新加坡医疗器材登记法规问题集
Email：sin4ww@evershinecpa.com
或
联络人：苏 玉 燕 副总经理
skype: rachelsu8
wechat: r0928486835
HLF-SG-10
请问新加坡对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?
它的政府管辖机构为何？网页？
What are the categories of medical devices in Singapore?
What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?
Evershine RD：
在新加坡，卫生部辖下的卫生科学局(HAS)是管理医疗器材的国家监管机构。
医疗器材是指任何仪器、器具、机器、体外诊断试剂、植入物、校准器、软体、材料、或其他相关的物品单独或组合使用于人体，出于以下任何一个或多个特定目的：
1. 任何疾病的诊断、预防、监测、治疗或缓解。
2. 损伤的诊断、监测、治疗或缓解或起到减轻的作用。
3.主要用于医学目的的解剖或生理过程的研究、替换、调节或支持。
4.支持或维持生命。
5. 妊娠控制。
6. 医疗器材消毒。
7. 出于医学或诊断目的，通过对源自于人体的样本进行体外检查来提供信息。
．用于调节或固定任何身体部位的任何植入物。
． 任何可注射的真皮填充剂或黏膜填充物
．通过侵入性方式去除或降解脂肪的任何仪器、器具或机器。
一般医疗器材
1. A 类(低风险)：例如轮椅或压舌板等。
2. B 类(低到中等风险) ：例如皮下注射针头或吸引设备等。
3. C 类(中到高风险) ：例如呼吸机或骨固定板等。
4. D 类(高风险) ：例如心脏瓣膜或植入式除颤器等。
影响医疗器材风险分类的因素包括
1. 医疗器材与身体接触的持续时间。
2. 侵入程度。
3. 医疗设备是否向患者提供医药产品或能量。
4. 是否对患者产生生物学影响。
5. 局部与全身效应（例如常规与可吸收缝线）。
6. 根据产品所有者的预期目的，如果两个或多个风险分类规则适用于医疗器材，则医疗器材被分配最高风险等级。
7. 一种医疗器材与另一种医疗器材同时使用的，风险分类规则应当分别适用于每一种医疗器材。
这与它们是否来自同一产品所有者无关（例如，生理监视器和单独的记录器，或通用注射器和注射器驱动器）。
体外诊断 (IVD) 医疗器材
1. A 类 (低个人风险和低公共卫生风险)：例如样品容器
2. B 类 (中等个人风险或低公共卫生风险或两者兼有) ：例如维生素B12、妊娠自检、抗核抗体、尿液试纸
3. C 类 (高个人风险或中等公共卫生风险或两者兼有) ：例如血糖自测、HLA 分型、PSA 筛检、 IgM检查
4. D 类 (高个人风险和高公共卫生风险) ：例如HIV筛查，HIV诊断试剂盒
影响 IVD 医疗器材风险分类因素包括
1. 确定产品是否符合体外诊断医疗器材的预期用途和使用适应症的定义。
2. 考虑到适当分类的规则。如果体外诊断医疗器材具有产品所有者规定的多种预期用途，将器材归为一个以上的类别，则应将其归为更高的类别。
3. 如果两个或多个风险分类规则适用于 IVD 医疗器材，则为其分配最高风险等级。
4. 应记录将产品置于特定风险等级的理由。
5. 其他需要考虑的因素包括：
．与 IVD 试剂一起使用的校准器应与 IVD 试剂归为同一级别。
．用于一种特定分析物或多种分析物的具有定量或定性指定值的独立对照材料应与 IVD 试剂归为同一类。
．用于多种或单一分析物的没有指定值的独立对照材料不应与 IVD 试剂归为同一类。
注意
1. 最低风险的A类医疗器材，可直接豁免医材登记。
2. 风险较高的B、C、D类医疗器材，需视情况分别经过完整评估（full evaluation）、简要评估（abridged evaluation）和快速评估（expedited evaluation）的审查途径。
3. 基本上B、C、D类医疗器材都可採取完整评估和简要评估；部分C、D类医疗器材可採取快速评估；部分等级B、C类医疗器材可採取立即评估。
In Singapore, the Health Sciences Authority (HAS) under the Ministry of Health is the national regulatory body for the management of medical devices.
A medical device means any instrument, appliance, machine, in vitro diagnostic reagent, implant, calibrator, software, material, or other related item used alone or in combination with the human body for any one or more of the following specific purposes:
1. The diagnosis, prevention, monitoring, treatment or mitigation of any disease.
2. Diagnosis, monitoring, treatment, or alleviation or mitigation of damage
3. The study, replacement, modulation or support of anatomical or physiological processes primarily for medical purposes.
4. Supports or sustains life.
5. Pregnancy management.
6. Disinfection of medical equipment.
7. For medical or diagnostic purposes, to provide information by performing in vitro examination of samples derived from humans.
．Any implant used to adjust or fix any part of the body.
．any injectable dermal fillers or mucosal fillers
．Any instrument, appliance or machine which removes or degrades fat by invasive means.
General Medical Devices
1. Class A (low risk): eg wheelchair or tongue depressor, etc.
2. Class B (low to moderate risk): For example, hypodermic needles or suction devices, etc.
3. Class C (moderate to high risk): such as ventilator or bone plate, etc.
4. Class D (high risk): such as heart valves or implantable defibrillators, etc.
Factors affecting the risk classification of medical devices include:
1. The duration of the medical device in contact with the body.
2. Degree of invasiveness.
3. Does the medical device deliver medicinal products or energy to the patient.
4. Whether there is a biological impact on the patient.
5. Local and systemic effects (eg conventional and absorbable sutures).
6. The medical device is assigned the highest risk class if two or more risk classification rules apply to the medical device, based on the intended purpose of the product owner.
7. When one medical device is used simultaneously with another medical device, the risk classification rules shall apply to each medical device separately.
This is irrelevant whether they are from the same product owner (eg, physiological monitor and separate recorder, or universal syringe and syringe driver).
In Vitro Diagnostic (IVD) Medical Devices
1. ClassA (low personal risk and low public health risk): e.g. sample containers.
2. ClassB (moderate personal risk or low public health risk or both): e.g. vitamin B12, pregnancy self-test, antinuclear antibodies, urine test strips.
3. ClassC (high personal risk or moderate public health risk or both): e.g. blood glucose self-test, HLA typing, PSA screening, IgM testing.
4. ClassD (high personal risk and high public health risk): eg HIV screening, HIV diagnostic kits.
Factors affecting the risk classification of IVD medical devices include:
1. Determine whether the product meets the definition of the intended use and indication for use of the IVD medical device.
2. Take into account the rules for proper classification. If an in vitro diagnostic medical device has more than one intended use as specified by the product owner and the device is classified in more than one category, it should be classified in a higher category.
3. If two or more risk classification rules apply to an IVD medical device, assign the highest risk class to it.
4. The justification for placing the product at a particular risk level should be documented.
5. Additional factors to consider include:
．Calibrators used with IVD reagents should be classified in the same class as IVD reagents.
．An independent control material with a quantitative or qualitative assigned value for a specific analyte or analytes should be classified in the same class as the IVD reagent.
．Independent control materials without assigned values for multiple or single analytes should not be classified in the same category as IVD reagents.
Notice
1. Medical equipment with the lowest risk of Class A can be directly exempted from medical material registration.
2. Class B, C, and D medical devices with higher risk need to go through the review process of full evaluation, abridged evaluation and expedited evaluation, respectively, depending on the situation.
3. Basically, all grades B, C, and D medical devices can be assessed in full and briefly; some grades C and D medical devices can be assessed quickly; some grades B and C medical devices can be assessed immediately.
【参考连结】
https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule
HLF-SG-20
外国公司要到新加坡销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell medical devices in Singapore, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
不需要营业特许证，但须以当地公司名义向HSA申请批发许可执照（Wholesaler’s license）。
持有此项执照方可在新加坡境内供应医疗器材。不过，对零售商供应医疗器材，则不需持有批发许可执照。
1.申请方式：
MEDICS网站提出线上申请。
2.申请文件：提交质量管理体系 (QMS) 的以下文件之一：
．ISO 13485证书(范围必须包括医疗器材的进口、储存和/或分销)。
．GDPMDS 证书(该证书需要由新加坡认可委员会（SAC）认可的认证机构颁发)。
．GDPMDS豁免声明 （仅用于再出口或非临床用途的进口）。
．质量管理体系符合性声明（仅适用于处理 A 类医疗器材的公司）。
No business license is required, but apply for a Wholesaler’s license to HSA in the name of a local company.
This license is required for the supply of medical equipment within Singapore. However, a wholesale license is not required for the supply of medical equipment to retailers.
1. Application method:
Online application is made on the MEDICS website.
2. Application documents: Submit one of the following documents for the quality management system (QMS):
．ISO 13485 certificate (the scope must cover the import, storage and/or distribution of medical devices).
．GDPMDS certificate (this certificate needs to be issued by a certification body accredited by Singapore Accreditation Council (SAC).
．GDPMDS Exemption Statement (for re-export or import for non-clinical use only).
．Declaration of Conformity for the Quality Management System (only for companies handling Class A medical devices).
【参考连结】
https://www.sac-accreditation.gov.sg/
https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
HLF-SG-25
假如需要办理，请问新加坡有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
不需要营业许可证。
HLF-SG-30
外国公司要到新加坡销售医疗器材，可以指派新加坡公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell medical devices in Singapore, can it assign a Singapore company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以，不需要营业特许证，但须以当地公司并向HSA申请批发许可执照（Wholesaler’s license）。
持有此项执照方可在新加坡境内供应医疗器材。不过，对零售商供应医疗器材，则不需持有批发许可执照。
1.申请方式：
MEDICS网站提出线上申请。
2.申请文件：提交质量管理体系 (QMS) 的以下文件之一：
．ISO 13485证书(范围必须包括医疗器材的进口、储存和/或分销)。
．GDPMDS 证书(该证书需要由新加坡认可委员会（SAC）认可的认证机构颁发)。
．GDPMDS豁免声明 （仅用于再出口或非临床用途的进口）。
．质量管理体系符合性声明（仅适用于处理 A 类医疗器材的公司）。
医疗器材不良事件报告
所有从事医疗器材交易的公司，包括进口商、製造商、供应商和註册人，都必须报告其产品的不良事件。
任何符合下列三个基本报告标准的不良事件 (AE) 均被视为可报告：
1. 发生了 AE（或潜在的 AE）。
2. 医疗设备与 AE 相关联。
3. AE 导致以下结果之一：
．成为对公众健康的严重威胁。
．患者、用户或其他人的死亡。
．患者、使用者或其他人的健康状况严重恶化。
．最初的 AE 没有死亡或重伤，但如果 AE 再次发生，可能会导致患者、用户或其他人死亡或重伤。
如何报告
不良事件的初步报告应包含尽可能详细的信息，如果一个可报告的 AE 涉及多个经销商，则每个经销商都必须提交自己的报告。
报告流程
通过电子邮件提交医疗器材经销商强制性医疗器材不良事件报告表。
何时报告
医疗器材公司，包括产品註册人、製造商、进口商和供应商，必须报告与其所经营的医疗器材相关的任何不良事件。
必须向我们报告以下与医疗器材相关的AE
1. 严重威胁公众健康：48小时
2. 死亡：10天
3. 健康状况严重恶化：10天
4. 如果不良事件再次发生，可能导致死亡或重伤：30天
注意：
1.一旦公司的任何人员（包括销售代表）了解 AE情况，报告的时间就开始了。如果不确定 AE 是否可报告，仍应在规定的时间范围内提交报告。
2.医疗器材经销商应在初始报告后 30 天内更新内容，详细说明对不良事件的调查，必要时可要求提供后续报告。
3.发生在新加坡境外但医疗器材也在新加坡供应的不良事件不需要报告。只有当这些医疗器材的註册或许可条件要求，或者收到要求提供不良事件信息的通知时，才需要报告。
No business license is required, but apply for a Wholesaler’s license to HSA in the name of a local company. This license is required for the supply of medical equipment within Singapore. However, a wholesale license is not required for the supply of medical equipment to retailers.
1. Application method:
Online application is made on the MEDICS website.
2. Application documents: Submit one of the following documents for the quality management system (QMS):
．ISO 13485 certificate (the scope must cover the import, storage and/or distribution of medical devices).
．GDPMDS certificate (this certificate needs to be issued by a certification body accredited by Singapore Accreditation Council (SAC).
．GDPMDS Exemption Statement (for re-export or import for non-clinical use only).
．Declaration of Conformity for the Quality Management System (only for companies handling Class A medical devices).
Medical device adverse event reporting
All companies that deal in medical devices, including importers, manufacturers, suppliers and registrants, are required to report adverse events with their products.
Any adverse event (AE) meeting the following three basic reporting criteria was considered reportable:
1. An AE (or potential AE) occurs.
2. The medical device is associated with the AE.
3. AE results in one of the following outcomes:
．Constitute a serious threat to public health.
．Death of a patient, user, or others.
．Serious deterioration of the patient’s, user’s or other person’s health.
．There was no death or serious injury from the initial AE, but if the AE recurs, it may cause death or serious injury to the patient, user, or others.
How to report
Preliminary reports of adverse events should contain as much detail as possible, and if a reportable AE involves multiple distributors, each distributor must submit its own report.
Report process
Submit the Medical Device Distributor Mandatory Medical Device Adverse Event Reporting Form by email.
When reporting
Medical device companies, including product registrants, manufacturers, importers and suppliers, must report any adverse events related to the medical devices they operate. The following medical device related AEs must be reported to us
1. Serious public health threat: 48 hours.
2. Dead: 10 days.
3. Serious deterioration in health: 10 days.
4. If the adverse event occurs again, it may cause death or serious injury: 30 days.
Notice:
1. Once any person in the company (including sales reps) is aware of the AE situation, the time for reporting begins.
If there is uncertainty as to whether an AE is reportable, the report should still be submitted within the time frame specified.
2. Medical device distributors should update the content within 30 days of the initial report detailing the investigation of the adverse event, and may request follow-up reports if necessary.
3. Adverse events that occur outside of Singapore but the medical equipment is also supplied in Singapore do not need to be reported. Reporting is required only if required by the conditions of registration or licensing of these medical devices, or if a notification has been received requiring adverse event information.
【参考连结】
https://www.hsa.gov.sg/medical-devices/adverse-events
https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
HLF-SG-35
HLF-SG-40
外国公司销售到新加坡医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing medical devices sold to Singapore?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要。医疗器材只有新加坡本地的公司可以申请产品註册。
海外的製造商有以下3种可能性在新加坡註册其医疗器材：
1. 在本地设立子公司来进行註册。
2. 指定拥有经销商执照、医疗器材良好分销实践认证(GDPMDS) 和註册账户的当地进口商或批发商通过MEDICS 註册医疗器材。
3. 委託独立第三方对医疗器材进行註册
B、C、D类产品註册：未经任何海外参考监管机构事先批准的医疗器材必须经过全面评估，包含以下内容。
1. 东盟共同提交档案模板 (CSDT)
．执行摘要
．基本原则清单
．符合性声明
．设备说明
．设计验证和确认文件的详细信息：临床前研究的完整报告，例如物理测试数据、生物相容性研究、动物研究以及软件验证和确认研究
．计量要求
．灭菌验证
．保质期研究和预计使用寿命
．临床评估报告，包括所引用研究的出版物和完整报告
．设备标籤
．风险分析
．生产场所和灭菌场所的名称和地址
．以下至少一项质量管理体系的证明：ISO 13485、符合美国 FDA 质量体係法规、日本厚生劳动省条例 169
．製造工艺流程图
．可能需要进一步的临床数据来支持设备在其正常使用之外的其他标记用途
2. 授权书
3. 医疗器材配置清单
产品标籤与包装
1.需要符合规范，于产品註册时审查。
2.产品标籤必须是英文
3.标籤上显示的基本信息应以人类可读的格式提供，但可以通过机器可读的格式进行补充，例如射频识别 (RFID) 或条形码。
4.标籤上的所有字符必须足够大且印刷清晰。
标籤的一般要素
1. 产品所有者的姓名、联繫方式（地址/电话号码/电子邮件地址）。
2. 医疗器材的商品或品牌名称，应提供在设备包装和使用说明上，以帮助用户识别设备以及与设备相关的使用说明。
3. 用户识别设备的足够详细信息，应在设备包装上提供，以帮助用户将设备与其他设备/类型区分。
4. 应在设备包装上提供批号/批号（例如一次性设备或试剂）或序列号（例如电动医疗设备）的指示，以便採取适当的行动来追踪和召回设备。
5. 在设备包装上提供明确指示设备可以安全使用的日期，至少以年、月表示，例如，在提供无菌、一次性设备或试剂的设备。
6. 如果标籤和/或 IFU 上指定了设备的预计使用寿命，则最终用户应在设备的整个使用过程中清楚地识别製造日期。这是为了帮助最终用户跟踪设备的剩馀使用寿命。
7. 明确标示截止日期。
8. 适用的任何特殊储存和/或处理条件的说明，包括第一次打开主容器后的储存条件、保质期，以及工作溶液的储存条件、稳定性。
9. 使用说明的发布日期或最新版本，以及识别号。
10. 如果医疗器材装在一个包装中，而包装内的物品不是很明显，则应说明包装内含的物品，并以适合医疗器材的术语表示，例如尺寸、淨重、长度、体积或单位数。
11. 使用医疗器材的任何特殊操作说明。
12. 如果设备的产品所有者打算将设备与其他医疗设备/专用软体一起安装或连接，则应提供识别此类设备的信息，和/或对医疗器材和设备组合的任何已知限制信息，以便获得安全组合，
13. 验证设备是否正确安装以及是否可以正确、安全运行所需的信息，包括性质的详细信息，预防性、定期维护的频率，任何质量控制，消耗性组件的更换以及校准所需的校准，确保设备在其预期寿命期间正常、安全地运行。
14. 产品所有者预期的性能和任何不良作用。
15. 用户正确使用设备所需的规格，例如 如果设备具有测量功能，设备设计达到的准确度。
16. 设备用户和/或第三方特殊设施、特殊培训或特定资格的任何要求。
17. 供非专业人士使用的设备，用户应谘询医疗保健专业人员的情况。
18. 可能适用于医疗器材使用的任何禁忌症、警告、限製或预防措施。
19. 任何需要立即引起医疗器材用户注意的警告、限制或预防措施，并在适当的情况下提请任何其他人注意（例如，注意 – 辐射危险）应提供在设备或其包装上。
20. 与设备中包含的材料有关的注意事项，例如：患者或使用者的致敏或过敏反应。
21. 警告、预防措施和/或在设备发生故障或性能发生变化时应採取的措施。
22. 在特定的诊断调查、评估、治疗或使用过程中，针对设备的合理可预见的干扰风险（例如设备发出的电磁干扰影响其他设备）。
23. 关于患者或用户暴露于合理可预见的环境条件或由于医疗设备的所有或任何物理特徵（如磁场、外部电和电磁效应、静电放电、压力或压力变化、温度、湿度、加速度。
24. 与设备、附件，以及一起使用的耗材（如果有）的相关警告或预防措施，应涵盖与设备相关的任何特殊或不寻常的风险，包括：
．感染或微生物危害（例如外植体、针头或外科设备被人源的潜在感染物质汙染）
．环境危害（例如，释放潜在危险辐射水平的电池或材料）
．物理危害（例如，锐器）
Yes. All medical devices and in-vitro diagnostic reagents must be registered for products, and only local companies in Singapore can apply for account registration products. Therefore, overseas manufacturers have three possibilities to register their medical devices in Singapore:
1. Establish a local subsidiary to register.
2. Designate a local importer or wholesaler with a Dealer License, Good Distribution Practice for Medical Devices Certification (GDPMDS) and a registered account to register the medical device with MEDICS.
3. Entrusting an independent third party to register medical devices
Category B, C, D Product Registration: Medical devices that have not been pre-approved by any overseas reference regulatory body must undergo a thorough evaluation, including the following.
1. ASEAN Common Submission Dossier Template (CSDT)
．Executive Summary
．Checklist of Basic Principles
．Declaration of Conformity
．Device Description
．Details of design validation and validation documentation: full reports of preclinical studies such as physical test data, biocompatibility studies, animal studies, and software validation and validation studies
．Measurement requirements
．Sterilization Validation
．Shelf life studies and expected useful life
．Clinical evaluation reports, including publications and full reports of the studies cited
．Device label
．Risk Analysis
．Names and addresses of production and sterilization sites
．Certification of at least one of the following quality management systems: ISO 13485, compliance with US FDA Quality System Regulations, Japanese Ministry of Health, Labour and Welfare Regulation 169
．Manufacturing process flow chart
．Further clinical data may be required to support other labeled uses of the device beyond its normal use
2. Power of Attorney
3. Medical equipment configuration list
Product Labeling & Packaging
1. It is required to comply with the specifications and be reviewed at the time of product registration.
2. The product label must be in English
3. The basic information displayed on the label should be provided in a human-readable format, but may be supplemented by a machine-readable format such as radio frequency identification (RFID) or barcodes.
4. All characters on the label must be large enough and printed clearly.
General Elements of Labeling
1. Product owner’s name, contact details (address/phone number/email address).
2. The commodity or brand name of the medical device should be provided on the device packaging and instructions for use to help users identify the device and the instructions for use related to the device.
3. Sufficient details for the user to identify the device should be provided on the device packaging to help the user distinguish the device from other devices/types.
4. An indication of the lot/lot number (eg single-use devices or reagents) or serial number (eg, powered medical devices) should be provided on the device packaging so that appropriate action can be taken to track and recall the device.
5. Provide a date on the device packaging that clearly indicates that the device is safe to use, at least in years and months, for example, where sterile, single-use devices or reagents are provided.
6. If the expected lifespan of the equipment is specified on the label and/or IFU, the end user should clearly identify the date of manufacture throughout the life of the equipment. This is to help end users track the remaining useful life of the device.
7. Clearly mark the due date.
8. Description of any special storage and/or handling conditions that apply, including storage conditions after first opening of the primary container, shelf life, and storage conditions, stability of working solutions.
9. Date or latest version of the instructions for use, and identification number.
10. If the medical device is contained in a package and the contents of the package are not obvious, the contents of the package should be stated and expressed in terms appropriate to the medical device, such as size, net weight, length, volume or number of units.
11. Any special handling instructions for using the medical device.
12. If the product owner of the device intends to install or connect the device with other medical devices/specialized software, information identifying such devices, and/or any known limitations on medical device and device combinations, shall be provided in order to get a safe combination,
13. Information required to verify that equipment is properly installed and can operate correctly and safely, including details of nature, frequency of preventive, scheduled maintenance, any quality control, replacement of expendable components, and calibration required for calibration, ensuring that Equipment operates normally and safely during its expected life.
14. Performance and any adverse effects expected by the product owner.
15. Specifications required by the user to properly use the device, eg, the accuracy the device is designed to achieve if the device has measurement capabilities.
16. Any requirements for equipment users and/or third parties for special facilities, special training or specific qualifications.
17. For equipment intended for use by non-professionals, users should consult a healthcare professional.
18. Any contraindications, warnings, restrictions or precautions that may apply to the use of the medical device.
19. Any warning, restriction or precaution that requires the immediate attention of the user of the medical device, and where appropriate, to the attention of any other person (eg, CAUTION – RADIATION HAZARD), shall be provided on the device or its packaging.
20. Precautions related to materials contained in the device, such as: sensitization or allergic reactions of patients or users.
21. Warnings, precautions and/or actions to be taken in the event of equipment failure or changes in performance.
22. The reasonably foreseeable risk of interference to the equipment during a particular diagnostic investigation, evaluation, treatment or use (eg electromagnetic interference from equipment affecting other equipment).
23. Regarding the exposure of the patient or user to reasonably foreseeable environmental conditions or due to all or any physical characteristics of the medical device (such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, pressure or pressure changes, temperature, humidity, acceleration.
24. Warnings or precautions associated with the equipment, accessories, and consumables (if any) used with the equipment should cover any special or unusual risks associated with the equipment, including:
． Infection or microbial hazard (e.g. contamination of explants, needles or surgical equipment with potentially infectious material of human origin)
． Environmental hazards (eg, batteries or materials that release potentially dangerous levels of radiation)
． Physical hazards (eg, sharps)
【参考连结】
https://www.hsa.gov.sg/medical-devices/registration/overview
HLF-SG-45
HLF-SG-50
外国公司可以用自己名义申请办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
不行，医疗器材只有新加坡本地的公司可以申请产品註册，除非符合以下条件:
海外的製造商有以下3种可能性在新加坡註册其医疗器材：
1. 在本地设立子公司来进行註册。
2. 指定拥有经销商执照、医疗器材良好分销实践认证(GDPMDS) 和註册账户的当地进口商或批发商通过MEDICS 註册医疗器材。
3. 委託独立第三方对医疗器材进行註册
B、C、D类产品註册：未经任何海外参考监管机构事先批准的医疗器材必须经过全面评估，包含以下内容。
1. 东盟共同提交档案模板 (CSDT)
．执行摘要
．基本原则清单
．符合性声明
．设备说明
．设计验证和确认文件的详细信息：临床前研究的完整报告，例如物理测试数据、生物相容性研究、动物研究以及软件验证和确认研究
．计量要求
．灭菌验证
．保质期研究和预计使用寿命
．临床评估报告，包括所引用研究的出版物和完整报告
．设备标籤
．风险分析
．生产场所和灭菌场所的名称和地址
．以下至少一项质量管理体系的证明：ISO 13485、符合美国 FDA 质量体係法规、日本厚生劳动省条例 169
．製造工艺流程图
．可能需要进一步的临床数据来支持设备在其正常使用之外的其他标记用途
2. 授权书
3. 医疗器材配置清单
产品标籤与包装
1.需要符合规范，于产品註册时审查。
2.产品标籤必须是英文
3.标籤上显示的基本信息应以人类可读的格式提供，但可以通过机器可读的格式进行补充，例如射频识别 (RFID) 或条形码。
4.标籤上的所有字符必须足够大且印刷清晰。
标籤的一般要素
1. 产品所有者的姓名、联繫方式（地址/电话号码/电子邮件地址）。
2. 医疗器材的商品或品牌名称，应提供在设备包装和使用说明上，以帮助用户识别设备以及与设备相关的使用说明。
3. 用户识别设备的足够详细信息，应在设备包装上提供，以帮助用户将设备与其他设备/类型区分。
4. 应在设备包装上提供批号/批号（例如一次性设备或试剂）或序列号（例如电动医疗设备）的指示，以便採取适当的行动来追踪和召回设备。
5. 在设备包装上提供明确指示设备可以安全使用的日期，至少以年、月表示，例如，在提供无菌、一次性设备或试剂的设备。
6. 如果标籤和/或 IFU 上指定了设备的预计使用寿命，则最终用户应在设备的整个使用过程中清楚地识别製造日期。这是为了帮助最终用户跟踪设备的剩馀使用寿命。
7. 明确标示截止日期。
8. 适用的任何特殊储存和/或处理条件的说明，包括第一次打开主容器后的储存条件、保质期，以及工作溶液的储存条件、稳定性。
9. 使用说明的发布日期或最新版本，以及识别号。
10. 如果医疗器材装在一个包装中，而包装内的物品不是很明显，则应说明包装内含的物品，并以适合医疗器材的术语表示，例如尺寸、淨重、长度、体积或单位数。
11. 使用医疗器材的任何特殊操作说明。
12. 如果设备的产品所有者打算将设备与其他医疗设备/专用软体一起安装或连接，则应提供识别此类设备的信息，和/或对医疗器材和设备组合的任何已知限制信息，以便获得安全组合，
13. 验证设备是否正确安装以及是否可以正确、安全运行所需的信息，包括性质的详细信息，预防性、定期维护的频率，任何质量控制，消耗性组件的更换以及校准所需的校准，确保设备在其预期寿命期间正常、安全地运行。
14. 产品所有者预期的性能和任何不良作用。
15. 用户正确使用设备所需的规格，例如 如果设备具有测量功能，设备设计达到的准确度。
16. 设备用户和/或第三方特殊设施、特殊培训或特定资格的任何要求。
17. 供非专业人士使用的设备，用户应谘询医疗保健专业人员的情况。
18. 可能适用于医疗器材使用的任何禁忌症、警告、限製或预防措施。
19. 任何需要立即引起医疗器材用户注意的警告、限制或预防措施，并在适当的情况下提请任何其他人注意（例如，注意 – 辐射危险）应提供在设备或其包装上。
20. 与设备中包含的材料有关的注意事项，例如：患者或使用者的致敏或过敏反应。
21. 警告、预防措施和/或在设备发生故障或性能发生变化时应採取的措施。
22. 在特定的诊断调查、评估、治疗或使用过程中，针对设备的合理可预见的干扰风险（例如设备发出的电磁干扰影响其他设备）。
23. 关于患者或用户暴露于合理可预见的环境条件或由于医疗设备的所有或任何物理特徵（如磁场、外部电和电磁效应、静电放电、压力或压力变化、温度、湿度、加速度。
24. 与设备、附件，以及一起使用的耗材（如果有）的相关警告或预防措施，应涵盖与设备相关的任何特殊或不寻常的风险，包括：
．感染或微生物危害（例如外植体、针头或外科设备被人源的潜在感染物质汙染）
．环境危害（例如，释放潜在危险辐射水平的电池或材料）
．物理危害（例如，锐器）
No. All medical devices and in-vitro diagnostic reagents must be registered for products, and only local companies in Singapore can apply for account registration products.
Therefore, overseas manufacturers have three possibilities to register their medical devices in Singapore:
1. Establish a local subsidiary to register.
2. Designate a local importer or wholesaler with a Dealer License, Good Distribution Practice for Medical Devices Certification (GDPMDS) and a registered account to register the medical device with MEDICS.
3. Entrusting an independent third party to register medical devices
Category B, C, D Product Registration: Medical devices that have not been pre-approved by any overseas reference regulatory body must undergo a thorough evaluation, including the following.
1. ASEAN Common Submission Dossier Template (CSDT)
．Executive Summary
．Checklist of Basic Principles
．Declaration of Conformity
．Device Description
．Details of design validation and validation documentation: full reports of preclinical studies such as physical test data, biocompatibility studies, animal studies, and software validation and validation studies
．Measurement requirements
．Sterilization Validation
．Shelf life studies and expected useful life
．Clinical evaluation reports, including publications and full reports of the studies cited
．Device label
．Risk Analysis
．Names and addresses of production and sterilization sites
．Certification of at least one of the following quality management systems: ISO 13485, compliance with US FDA Quality System Regulations, Japanese Ministry of Health, Labour and Welfare Regulation 169
．Manufacturing process flow chart
．Further clinical data may be required to support other labeled uses of the device beyond its normal use
2. Power of Attorney
3. Medical equipment configuration list
Product Labeling & Packaging
1. It is required to comply with the specifications and be reviewed at the time of product registration.
2. The product label must be in English
3. The basic information displayed on the label should be provided in a human-readable format, but may be supplemented by a machine-readable format such as radio frequency identification (RFID) or barcodes.
4. All characters on the label must be large enough and printed clearly.
General Elements of Labeling
1. Product owner’s name, contact details (address/phone number/email address).
2. The commodity or brand name of the medical device should be provided on the device packaging and instructions for use to help users identify the device and the instructions for use related to the device.
3. Sufficient details for the user to identify the device should be provided on the device packaging to help the user distinguish the device from other devices/types.
4. An indication of the lot/lot number (eg single-use devices or reagents) or serial number (eg, powered medical devices) should be provided on the device packaging so that appropriate action can be taken to track and recall the device.
5. Provide a date on the device packaging that clearly indicates that the device is safe to use, at least in years and months, for example, where sterile, single-use devices or reagents are provided.
6. If the expected lifespan of the equipment is specified on the label and/or IFU, the end user should clearly identify the date of manufacture throughout the life of the equipment. This is to help end users track the remaining useful life of the device.
7. Clearly mark the due date.
8. Description of any special storage and/or handling conditions that apply, including storage conditions after first opening of the primary container, shelf life, and storage conditions, stability of working solutions.
9. Date or latest version of the instructions for use, and identification number.
10. If the medical device is contained in a package and the contents of the package are not obvious, the contents of the package should be stated and expressed in terms appropriate to the medical device, such as size, net weight, length, volume or number of units.
11. Any special handling instructions for using the medical device.
12. If the product owner of the device intends to install or connect the device with other medical devices/specialized software, information identifying such devices, and/or any known limitations on medical device and device combinations, shall be provided in order to get a safe combination,
13. Information required to verify that equipment is properly installed and can operate correctly and safely, including details of nature, frequency of preventive, scheduled maintenance, any quality control, replacement of expendable components, and calibration required for calibration, ensuring that Equipment operates normally and safely during its expected life.
14. Performance and any adverse effects expected by the product owner.
15. Specifications required by the user to properly use the device, eg, the accuracy the device is designed to achieve if the device has measurement capabilities.
16. Any requirements for equipment users and/or third parties for special facilities, special training or specific qualifications.
17. For equipment intended for use by non-professionals, users should consult a healthcare professional
18. Any contraindications, warnings, restrictions or precautions that may apply to the use of the medical device.
19. Any warning, restriction or precaution that requires the immediate attention of the user of the medical device, and where appropriate, to the attention of any other person (eg, CAUTION – RADIATION HAZARD), shall be provided on the device or its packaging.
20. Precautions related to materials contained in the device, such as: sensitization or allergic reactions of patients or users.
21. Warnings, precautions and/or actions to be taken in the event of equipment failure or changes in performance.
22. The reasonably foreseeable risk of interference to the equipment during a particular diagnostic investigation, evaluation, treatment or use (eg electromagnetic interference from equipment affecting other equipment).
23. Regarding the exposure of the patient or user to reasonably foreseeable environmental conditions or due to all or any physical characteristics of the medical device (such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, pressure or pressure changes, temperature, humidity, acceleration.
24. Warnings or precautions associated with the equipment, accessories, and consumables (if any) used with the equipment should cover any special or unusual risks associated with the equipment, including:
． Infection or microbial hazard (e.g. contamination of explants, needles or surgical equipment with potentially infectious material of human origin)
． Environmental hazards (eg, batteries or materials that release potentially dangerous levels of radiation
． Physical hazards (eg, sharps)
【参考连结】
https://www.hsa.gov.sg/medical-devices/guidance-documents
HLF-SG-55
HLF-SG-60
经过核准登记的医疗器材，进口到新加坡要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved medical devices into Singapore? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
需要当地公司名义申请进口商许可证，由进口商许可证持有者名义进口医疗器材。
进口商许可证（Importer’s licence）
1.申请方式：
MEDICS网站提出线上申请。
2.申请文件：提交质量管理体系 (QMS) 的以下文件之一：
．ISO 13485证书(范围必须包括医疗器材的进口、储存和/或分销)。
．GDPMDS 证书(该证书需要由新加坡认可委员会（SAC）认可的认证机构颁发)。
．GDPMDS豁免声明 （仅用于再出口或非临床用途的进口）。
．质量管理体系符合性声明（仅适用于处理 A 类医疗器材的公司）。
．如果不进口任何 A 类医疗器材，请提交不经营 A 类医疗器材声明。
海关进口许可证：
新加坡对进口商品检验检疫的标准和程序十分严格。负责进口医疗器材商品检验的部门是HSA。
1. 註册入口网站的帐户
https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct
．需使用HSA产品代码提交进口申报，并提供相关许可和/或批准资料。
．产品代码：HSAHP、HSAIFRSA
2. 指定报关代理人(新加坡物流协会/新加坡航空货运代理协会)或由进口商许可证持有者申报。
．必须与新加坡海关负责银行 GIRO (IBG)绑定以直接从您的银行账户向新加坡海关支付新加坡海关提供的服务的关税、税款、费用、罚款和其他费用。
．如果没有在新加坡海关持有 IBG，关税和 GST 将从您的申报代理的 IBG 中扣除。
3. 提供安全保障
．需要为涉及应课税货物的交易、为批准目的临时进口货物以及经营特许经营场所（如特许仓库和消费税工厂）提供担保。
．提供的担保应採用银行担保、财务公司担保或保证金的形式。
4. 获得海关进口许可证
．申请必须透由TradeNet提交 (TradeNet软体、政府应用程序)
．每份许可证的申请费用通常是2.88新元，不包含报关代理服务费等，如委託报关公司代理，可以查阅其收取的服务费用。
文件内容
．申请公司(须以公司名义报关，如为个人可以委託代办公司申请)、邮政编码、地址、电话、传真、行业
．联繫人、联繫方式、电话、传真、电子邮件
．计费管理员(通常是主管或财务人员)姓名、身分证/护照号码、联繫方式、电子邮件
．付款方式
．签章
5. 准备货物清关文件
．提供证明文件，包括发票、包装清单及提单/空运提单
．集装箱货物所需文件
通过海运进口集装箱货物，无需向入境口岸的检查站人员出示海关许可证和证明文件的打印副本。
通过空运或陆运进口集装箱货物，需要出示海关许可证以及发票、装箱单和提单/空运提单等证明文件，向检查站官员核实。
．常规货物所需文件
对于常规货物，请在货物清关时将货物、海关通行证打印件、发票、装箱单、提单/空运单等证明文件交给口检人员核对。
．保留贸易文件
购买、进口、销售或出口货物有关的相关证明文件自许可证申请批准之日起保留 5 年。
6. 提交申报时，请遵守以下要求：
．使用适用的 HSA 产品代码，在单独的项目序列号上声明每个产品。
．产品代码计量单位 (UOM) 必须与声明的 HS UOM 匹配。
．即使产品使用相同的 HS 编码，也不要为每个商品序列号申报超过一件商品。
．声明产品标籤上的完整产品名称。
．在 CA/SC 代码字段中声明相关的许可/批准信息。
It is necessary to apply for an importer license in the name of the local company, and the importer license holder will import medical equipment.
Importer’s license
1. Application method:
The MEDICS website makes an online application.
2. Application documents: Submit one of the following documents for the quality management system (QMS):
．ISO 13485 certificate (the scope must cover the import, storage and/or distribution of medical devices).
．GDPMDS certificate (this certificate needs to be issued by a certification body accredited by Singapore Accreditation Council (SAC).
Website: https://www.sac-accreditation.gov.sg/
．GDPMDS Exemption Statement (for re-export or import for non-clinical use only).
．Declaration of Conformity for the Quality Management System (only for companies handling Class A medical devices).
．If you do not import any Class A medical devices, please submit a declaration of not operating Class A medical devices.
Customs import license:
Singapore has strict standards and procedures for the inspection and quarantine of imported goods. The department responsible for commodity inspection of imported medical devices is HSA.
1. Register an account on the portal
https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct
． An import declaration is required to be submitted using the HSA product code, along with relevant license and/or approval information.
． Product Code: HSAHP, HSAIFRSA
2. Designated customs broker (Singapore Logistics Association/Singapore Air Freight Forwarders Association) or declared by the importer license holder.
． Must be tied to Singapore Customs Responsible Bank GIRO (IBG) to pay Singapore Customs duties, taxes, fees, fines and other charges for services provided by Singapore Customs directly from your bank account.
． If the IBG is not held at Singapore Customs, duties and GST will be deducted from your reporting agent’s IBG.
3. Provide security
．Guarantee is required for transactions involving dutiable goods, temporary importation of goods for approved purposes, and the operation of franchise premises such as licensed warehouses and excise factories.
．Guarantees provided should be in the form of bank guarantees, finance company guarantees or security deposits.
4. Obtain customs import license
．Applications must be submitted through TradeNet (TradeNet software, government applications)
．The application fee for each license is usually S$2.88, excluding customs brokerage service fees.
Document content
．Application company (customs declaration must be made in the name of the company, if it is an individual, you can entrust an agency company to apply), zip code, address, telephone, fax, industry
．Contact, Contact, Phone, Fax, Email
． Billing administrator (usually supervisor or financial officer) name, ID/passport number, contact details, email
．Payment method
．Signature
5. Prepare cargo clearance documents
．Provide supporting documents including invoice, packing list and bill of lading/air waybill
．Documents Required for Containerized Cargo
Importing containerized cargo by sea eliminates the need to present printed copies of customs permits and supporting documents to checkpoint personnel at the port of entry.
To import containerized cargo by air or land, you need to present a customs permit and supporting documents such as invoice, packing list and bill of lading/airway bill to verify with the checkpoint officer.
．Documents Required for Regular Cargo
For conventional goods, please submit the goods, printed copies of customs passes, invoices, packing lists, bills of lading/airway bills and other supporting documents to the inspection personnel for verification when the goods are cleared.
．Keep trade documents
Relevant supporting documents related to the purchase, import, sale or export of goods are retained for 5 years from the date of approval of the license application.
6. When submitting the declaration, please observe the following requirements:
．Claim each product on a separate item serial number using the applicable HSA product code.
．The product code Unit of Measure (UOM) must match the declared HS UOM.
．Do not declare more than one item per item serial number, even if the products use the same HS code.
．Claim the full product name on the product label.
．Declare the relevant licensing/approval information in the CA/SC code field.
【参考连结】
https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
https://www.customs.gov.sg/businesses/importing-goods/overview
HLF-SG-70
新加坡医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
DPMDS SS620认证：质量管理体系要求
1.一般要求
建立的质量管理体系应足够稳健，以满足外部和内部考虑，例如法规要求的变化、客户反馈、关键人员、设施的变化等。
2.文件要求
程序中所需的结构、详细程度应根据组织的需要进行调整。程序或说明可以任何形式（文本、图形或视听）或媒介呈现。
．文件控制：应有适当的控制以确保文件的准确性、可用性、易读性和可追溯性。
．记录控制：组织应保留所有所需的记录，以说明其遵守 SS GDPMDS 中的各种相关条款。 在使用电子记录系统代替纸质系统的情况下，所使用的系统应具有内置的製衡机制，以确保记录的完整性并防止未经授权的输入。 该系统还应包含用于跟踪更改的审计跟踪。
3. 管理责任
．组织应在质量管理体系中记录工作描述，包括关键职责和权限。
．管理代表：管理代表的任命应记录在案，例如 在站点主文件或正式任命信中。 只有一名管理层成员被授权为组织的管理层代表。 在管理代表缺席的情况下，可以任命一名副手。管理者代表履行的其他职责和职能与与质量管理体系相关的职责和职能之间不能有利益冲突。
4. 管理评审
．最高管理者应定期审查质量管理体系，至少每年一次，以确保质量管理体系保持有效。
．审核输入、输出
．管理记录可以採用适合组织的任何形式，包括正式的会议记录或会议记录，应以纸本或电子方式製作、分发和存储。 管理评审的记录应包括参与评审的人员的身份、评审日期和所有评审输入和输出SS GDPMDS 中列出的方面。 这包括对要採取的任何纠正或预防措施的描述。
．对于确定的任何行动，应确定此类行动的责任、资源、目标完成日期等。
5.资源管理
．人员：组织应考虑参与医疗器材分销的人员的经验、资格、能力和能力。在质量体系内工作的人员需要一定程度的能力或培训（内部或外部）才能正确执行任务。培训可以採取在职培训/主管指导、指导简报、课程、讲习班等形式。
对处理某些类别的物质/材料（如化学、生物、辐射发射或能源）的人员可能需要特殊培训组件或产品，以及需要冷链管理的组件或产品。
．培训：人员培训应根据人员的角色和职责进行调整。
6. 场地和设施
．储存、仓储和库存处理
收货区应保护货物在卸货过程中免受外部环境（例如雨）的损坏。接收区应与存储区分开。用于储存、仓储和库存处理的场所应具有足够的安全性，以防止未经授权的访问和盗用医疗器材。场所应保护医疗设备免受汙染和变质，包括防止过热或过度暴露在阳光直射下。储存区域应有足够的照明和通风。不应允许吸烟、进食和饮水。应该有足够的存储区域，并在适用的情况下，物理上分开的区域，以便有序地隔离医疗器材。应为隔离、可销售库存、过期、拒收/损坏、召回和退回的医疗器材设立指定区域。替代方法如果得到证实，可以考虑隔离，以防止混淆。
．适用于医疗器材的储存温度应根据製造商的建议，通常在标籤上标明特别的存储要求。
．应以适当的预定时间间隔测量存储区域的温度，以显示当天的最高和最低温度并记录下来，还应进行湿度测量。 温度监测器应位于最有可能出现波动的区域。
．需要特殊储存条件（即 8°C 及以下的储存条件）的医疗器材需要冷链管理。
．清洁度：存储区域应保持清洁，并应定期清除废物。 医疗器材应远离地面存放并保持适当的间距，以便进行清洁和检查。 托盘应妥善保养并保持良好的清洁状态。 应採取充分的预防措施，防止溢出或破损、汙染和交叉汙染。
．害虫防治：应设置储存区以防止昆虫、囓齿动物和其他害虫/动物进入。 需要保留的记录示例包括第三方害虫防治公司出具的服务报告、内部诱饵更换记录、害虫类型和数量。
．库存周转：应保存全部批次/批号/序列号或同等数量的所有进出医疗器材记录，医疗器材的定期库存核对应通过将实际库存数量与记录的库存数量进行比较。
．医疗器材的交付：应制定程序将所有医疗器材从发佈点到交付点安全、可靠的交付。
7.安装和维修
．安装活动：应建立执行和验证安装是否满足规定要求的说明和程序。只有经过适当培训和合格的人员才能进行医疗设备的安装。
．服务活动：应制定执行和验证服务（包括修理和维护）是否满足规定要求的说明和程序。只有经过适当培训和合格的人员才能对医疗设备进行维修。
．校准：用于测量和监测的仪器（例如温度、湿度和电流）应定期校准或验证其准确性，并记录和保存此类校准或验证的结果。 校准应由合格人员或相关方执行。
．医疗器材的退货：任何退回组织的产品都应被视为不合格产品，在确定处置评估之前，退回的医疗器材只能作为可销售库存，并由授权人员进行质量重新评估。
．医疗器材的处置：不符合规格的医疗器材（例如过期、汙染、损坏、有缺陷等）应妥善处置。 应建立控制以确保用于处置的医疗器材无法再供应，并且按照程序和製造商的说明（如果有）进行处置。处置方法可能包括但不限于焚烧、返还给产品所有者等。
8. 认证机构：需要由新加坡认可委员会（SAC）认可的认证机构颁发
https://www.sac-accreditation.gov.sg/
9. 网页：https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
医疗器材产品註册需缴交技术文件，包含以下内容(Technical Reference Documents)：
1. 证明符合性的相关基本原则和方法
2. 设备说明
．设备描述和功能
．预期用途
．适应症
．使用说明
．禁忌症
．警告
．预防措施
．潜在的不利影响
．替代
．材料
．其他相关规范
．其他描述性信息
3. 设计验证和确认文件摘要
．临床前研究
．临床证据
4. 设备标籤
．设备及其包装上的标籤
．使用说明
5. 风险分析结果
6. 製造商信息、製造工艺
7. 参考文献
DPMDS SS620 Certification: Requirements for Quality Management System
1. General requirements
The established quality management system should be robust enough to meet external and internal considerations, such as changes in regulatory requirements, customer feedback, key personnel, changes in facilities, etc.
2. Document Requirements
The required structure and level of detail in the program should be adapted to the needs of the organization. Programs or instructions can be presented in any form (text, graphic or audiovisual) or medium.
．Document Control: Appropriate controls should be in place to ensure the accuracy, usability, legibility and traceability of documents.
．Records Control: The organization shall maintain all required records to demonstrate its compliance with the various relevant clauses in the SS GDPMDS. Where an electronic recording system is used in place of a paper-based system, the system used should have built-in checks and balances to ensure the integrity of the records and prevent unauthorized entry. The system should also contain an audit trail for tracking changes.
3. Management responsibility
．The organization shall document job descriptions in the quality management system, including key responsibilities and authorities.
．Management Representative: The appointment of a management representative should be documented, such as in the site master file or in a formal letter of appointment. Only one management member is authorized to be the management representative of the organization. In the absence of the management representative, a deputy may be appointed. There shall be no conflict of interest between other responsibilities and functions performed by the management representative and those related to the quality management system.
4. Management Review
．Top management should review the quality management system periodically, at least annually, to ensure that the quality management system remains effective.
．Audit input and output
．Administrative records may take any form appropriate to the organization, including official meeting minutes or minutes, and should be produced, distributed and stored in paper or electronic form. Records of management reviews shall include the identity of those who participated in the review, the date of the review and the aspects listed in the SS GDPMDS for all review inputs and outputs. This includes a description of any corrective or preventive action to be taken.
．For any actions identified, responsibilities, resources, target completion dates, etc. for such actions should be identified.
5. Resource management
．Personnel: Organizations should consider the experience, qualifications, competencies, and competencies of personnel involved in the distribution of medical devices. People working within a quality system require a certain level of competence or training (internal or external) to perform their tasks properly. Training can take the form of on-the-job training/supervisor mentoring, mentoring briefings, courses, workshops, etc. Special training components or products may be required for personnel handling certain classes of substances/materials such as chemical, biological, radiation emissions or energy, as well as components or products requiring cold chain management.
．Training: Personnel training should be tailored to the person’s role and responsibilities.
6. Venues and Facilities
． Storage, warehousing and inventory handling
The receiving area should protect the cargo from damage from the external environment (eg rain) during unloading. The receiving area should be separate from the storage area. Facilities used for storage, warehousing, and inventory handling shall have adequate security to prevent unauthorized access and misappropriation of medical equipment. Sites should protect medical equipment from contamination and deterioration, including protection from overheating or excessive exposure to direct sunlight. Storage areas should have adequate lighting and ventilation. Smoking, eating and drinking should not be allowed. There should be adequate storage areas and, where applicable, physically separated areas for orderly segregation of medical equipment. Designated areas should be established for quarantined, marketable inventory, expired, rejected/damaged, recalled, and returned medical equipment. Alternative approaches, if proven, may be considered for isolation to prevent confusion.
．Suitable storage temperatures for medical devices should be based on the manufacturer’s recommendations, usually on the label indicating specific storage requirements.
．The temperature of the storage area should be measured at appropriate predetermined intervals to show the day’s maximum and minimum temperatures and recorded, and humidity measurements should also be taken. Temperature monitors should be located in areas where fluctuations are most likely.
．Medical devices that require special storage conditions (i.e. storage conditions of 8°C and below) require cold chain management.
．Cleanliness: Storage areas should be kept clean and waste should be removed regularly. Medical equipment should be stored off the ground with proper spacing for cleaning and inspection. Trays should be properly maintained and kept in good clean condition. Adequate precautions should be taken to prevent spills or breakage, contamination and cross-contamination.
．Pest Control: Storage areas should be provided to prevent entry of insects, rodents and other pests/animals. Examples of records to keep include service reports from third-party pest control companies, internal bait replacement records, and pest types and numbers.
．Inventory Turnover: A record of all incoming and outgoing medical devices should be maintained for all batches/lots/serial numbers or equivalent, and periodic inventory reconciliation of medical devices should be done by comparing actual inventory quantities to recorded inventory quantities.
．Delivery of Medical Devices: Procedures should be in place for the safe and secure delivery of all medical devices from the point of release to the point of delivery.
7. Installation and maintenance
．Installation Activities: Instructions and procedures shall be established to perform and verify that the installation meets specified requirements. Only properly trained and qualified personnel should perform the installation of medical equipment.
．Service Activities: Instructions and procedures for performing and verifying that services, including repairs and maintenance, meet specified requirements shall be developed. Repairs to medical equipment should only be performed by properly trained and qualified personnel.
．Calibration: Instruments used for measurement and monitoring (such as temperature, humidity, and current) should be periodically calibrated or verified for accuracy, and the results of such calibration or verification should be recorded and maintained. Calibration should be performed by qualified personnel or interested parties.
．Returns of Medical Devices: Any product returned to the organization should be considered nonconforming product, and until a disposition evaluation is determined, returned medical devices may only be held as sellable inventory and subject to quality re-evaluation by authorized personnel.
．Disposal of Medical Devices: Medical devices that do not meet specifications (eg expired, contaminated, damaged, defective, etc.) should be disposed of properly. Controls should be established to ensure that medical devices used for disposal are no longer available and are disposed of in accordance with procedures and manufacturer’s instructions, if any. Disposal methods may include, but are not limited to, incineration, return to product owner, etc.
8. Certification body: It needs to be issued by a certification body accredited by the Singapore Accreditation Council (SAC).
https://www.sac-accreditation.gov.sg/
9. URL: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
The registration of medical device products requires the submission of technical documents, including the following contents (Technical Reference Documents):
1. Relevant basic principles and methods for demonstrating conformity
2. Device Description
． Device Description and Features
． Intended usage
． Indications
． Instructions for use
． Contraindications
． Warn
． Precaution
． Potential Adverse Effects
． Substitute
． Material
． Other relevant specifications
． Additional descriptive information
3. Summary of Design Verification and Validation Documents
．Preclinical studies
．Clinical evidence
4. Equipment label
．Labels on the device and its packaging
．Instructions for use
5. Risk Analysis Results
6. Manufacturer Information, Manufacturing Process
7. References
【参考连结】
https://www.hsa.gov.sg/medical-devices/guidance-documents
https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
HLF-SG-75
HLF-SG-77
HLF-SG-80
外国子公司进口医疗器材后，如果委託新加坡的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？
是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports medical devices and entrusts a distributor in Singapore to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
须为当地公司并向HSA申请批发许可执照（Wholesaler’s license）。持有此项执照方可在新加坡境内供应医疗器材。不过，对零售商供应医疗器材，则不需持有批发许可执照。
1.申请方式：
MEDICS网站提出线上申请。
2.申请文件：提交质量管理体系 (QMS) 的以下文件之一：
．ISO 13485证书(范围必须包括医疗器材的进口、储存和/或分销)。
．GDPMDS 证书(该证书需要由新加坡认可委员会（SAC）认可的认证机构颁发)。
．GDPMDS豁免声明 （仅用于再出口或非临床用途的进口）。
．质量管理体系符合性声明（仅适用于处理 A 类医疗器材的公司）。
医疗器材不良事件报告
所有从事医疗器材交易的公司，包括进口商、製造商、供应商和註册人，都必须报告其产品的不良事件。
任何符合下列三个基本报告标准的不良事件 (AE) 均被视为可报告：
1. 发生了 AE（或潜在的 AE）。
2. 医疗设备与 AE 相关联。
3. AE 导致以下结果之一：
．成为对公众健康的严重威胁。
．患者、用户或其他人的死亡。
．患者、使用者或其他人的健康状况严重恶化。
．最初的 AE 没有死亡或重伤，但如果 AE 再次发生，可能会导致患者、用户或其他人死亡或重伤。
如何报告
不良事件的初步报告应包含尽可能详细的信息，如果一个可报告的 AE 涉及多个经销商，则每个经销商都必须提交自己的报告。
报告流程
通过电子邮件提交医疗器材经销商强制性医疗器材不良事件报告表。
何时报告
医疗器材公司，包括产品註册人、製造商、进口商和供应商，必须报告与其所经营的医疗器材相关的任何不良事件。
必须向我们报告以下与医疗器材相关的AE
1. 严重威胁公众健康：48小时
2. 死亡：10天
3. 健康状况严重恶化：10天
4. 如果不良事件再次发生，可能导致死亡或重伤：30天
注意：
1.一旦公司的任何人员（包括销售代表）了解 AE情况，报告的时间就开始了。如果不确定 AE 是否可报告，仍应在规定的时间范围内提交报告。
2.医疗器材经销商应在初始报告后 30 天内更新内容，详细说明对不良事件的调查，必要时可要求提供后续报告。
3.发生在新加坡境外但医疗器材也在新加坡供应的不良事件不需要报告。
只有当这些医疗器材的註册或许可条件要求，或者收到要求提供不良事件信息的通知时，才需要报告。
Apply for a Wholesaler’s license to HSA in the name of a local company. This license is required for the supply of medical equipment within Singapore. However, a wholesale license is not required for the supply of medical equipment to retailers.
1. Application method:
Online application is made on the MEDICS website.
2. Application documents: Submit one of the following documents for the quality management system (QMS):
．ISO 13485 certificate (the scope must cover the import, storage and/or distribution of medical devices).
．GDPMDS certificate (this certificate needs to be issued by a certification body accredited by Singapore Accreditation Council (SAC).
URL: https://www.sac-accreditation.gov.sg/
．GDPMDS Exemption Statement (for re-export or import for non-clinical use only).
．Declaration of Conformity for the Quality Management System (only for companies handling Class A medical devices).
URL: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
Medical device adverse event reporting
All companies that deal in medical devices, including importers, manufacturers, suppliers and registrants, are required to report adverse events with their products.
Any adverse event (AE) meeting the following three basic reporting criteria was considered reportable:
1. An AE (or potential AE) occurs.
2. The medical device is associated with the AE.
3. AE results in one of the following outcomes:
．Constitute a serious threat to public health.
．Death of a patient, user, or others.
．Serious deterioration of the patient’s, user’s or other person’s health.
．There was no death or serious injury from the initial AE, but if the AE recurs, it may cause death or serious injury to the patient, user, or others.
How to report
Preliminary reports of adverse events should contain as much detail as possible, and if a reportable AE involves multiple distributors, each distributor must submit its own report.
Report process
Submit the Medical Device Distributor Mandatory Medical Device Adverse Event Reporting Form by email.
When reporting
Medical device companies, including product registrants, manufacturers, importers and suppliers, must report any adverse events related to the medical devices they operate. The following medical device related AEs must be reported to us
1. Serious public health threat: 48 hours.
2. Dead: 10 days.
3. Serious deterioration in health: 10 days.
4. If the adverse event occurs again, it may cause death or serious injury: 30 days.
Notice:
1. Once any person in the company (including sales reps) is aware of the AE situation, the time for reporting begins. If there is uncertainty as to whether an AE is reportable, the report should still be submitted within the time frame specified.
2. Medical device distributors should update the content within 30 days of the initial report detailing the investigation of the adverse event, and may request follow-up reports if necessary.
3. Adverse events that occur outside of Singapore but the medical equipment is also supplied in Singapore do not need to be reported. Reporting is required only if required by the conditions of registration or licensing of these medical devices, or if a notification has been received requiring adverse event information.
【参考连结】
https://www.hsa.gov.sg/medical-devices/adverse-events
https://www.hsa.gov.sg/medical-devices/dealers-licence/apply
HLF-SG-85
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