新加坡醫療器材登記法規問題集 -

新加坡醫療器材登記法規問題集

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文章目錄 點擊收合

HLF-SG-10請問新加坡對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

HLF-SG-20外國公司要到新加坡銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

HLF-SG-30外國公司要到新加坡銷售醫療器材，可以指派新加坡公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

HLF-SG-40外國公司銷售到新加坡醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

HLF-SG-60經過核准登記的醫療器材，進口到新加坡要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

HLF-SG-70新加坡醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

HLF-SG-80外國子公司進口醫療器材後，如果委託新加坡的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

各國醫療器材登記法規問答集

HLF-SG-10
請問新加坡對於醫療器材的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?
它的政府管轄機構為何？網頁？

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，衛生部轄下的衛生科學局(HAS)是管理醫療器材的國家監管機構。
醫療器材是指任何儀器、器具、機器、體外診斷試劑、植入物、校準器、軟體、材料、或其他相關的物品單獨或組合使用於人體，出於以下任何一個或多個特定目的：

1. 任何疾病的診斷、預防、監測、治療或緩解。

2. 損傷的診斷、監測、治療或緩解或起到減輕的作用。

3.主要用於醫學目的的解剖或生理過程的研究、替換、調節或支持。

4.支持或維持生命。

5. 妊娠控制。

6. 醫療器材消毒。

7. 出於醫學或診斷目的，通過對源自於人體的樣本進行體外檢查來提供信息。

．用於調節或固定任何身體部位的任何植入物。

．任何可注射的真皮填充劑或黏膜填充物

．通過侵入性方式去除或降解脂肪的任何儀器、器具或機器。

一般醫療器材

1. A 類(低風險)：例如輪椅或壓舌板等。

2. B 類(低到中等風險) ：例如皮下注射針頭或吸引設備等。

3. C 類(中到高風險) ：例如呼吸機或骨固定板等。

4. D 類(高風險) ：例如心臟瓣膜或植入式除顫器等。

影響醫療器材風險分類的因素包括

1. 醫療器材與身體接觸的持續時間。

2. 侵入程度。

3. 醫療設備是否向患者提供醫藥產品或能量。

4. 是否對患者產生生物學影響。

5. 局部與全身效應（例如常規與可吸收縫線）。

6. 根據產品所有者的預期目的，如果兩個或多個風險分類規則適用於醫療器材，則醫療器材被分配最高風險等級。

7. 一種醫療器材與另一種醫療器材同時使用的，風險分類規則應當分別適用於每一種醫療器材。
這與它們是否來自同一產品所有者無關（例如，生理監視器和單獨的記錄器，或通用注射器和注射器驅動器）。

體外診斷 (IVD) 醫療器材

1. A 類 (低個人風險和低公共衛生風險)：例如樣品容器

2. B 類 (中等個人風險或低公共衛生風險或兩者兼有) ：例如維生素B12、妊娠自檢、抗核抗體、尿液試紙

3. C 類 (高個人風險或中等公共衛生風險或兩者兼有) ：例如血糖自測、HLA 分型、PSA 篩檢、 IgM檢查

4. D 類 (高個人風險和高公共衛生風險) ：例如HIV篩查，HIV診斷試劑盒

影響 IVD 醫療器材風險分類因素包括

1. 確定產品是否符合體外診斷醫療器材的預期用途和使用適應症的定義。

2. 考慮到適當分類的規則。如果體外診斷醫療器材具有產品所有者規定的多種預期用途，將器材歸為一個以上的類別，則應將其歸為更高的類別。

3. 如果兩個或多個風險分類規則適用於 IVD 醫療器材，則為其分配最高風險等級。

4. 應記錄將產品置於特定風險等級的理由。

5. 其他需要考慮的因素包括：

．與 IVD 試劑一起使用的校準器應與 IVD 試劑歸為同一級別。

．用於一種特定分析物或多種分析物的具有定量或定性指定值的獨立對照材料應與 IVD 試劑歸為同一類。

．用於多種或單一分析物的沒有指定值的獨立對照材料不應與 IVD 試劑歸為同一類。

注意

1. 最低風險的A類醫療器材，可直接豁免醫材登記。

2. 風險較高的B、C、D類醫療器材，需視情況分別經過完整評估（full evaluation）、簡要評估（abridged evaluation）和快速評估（expedited evaluation）的審查途徑。

3. 基本上B、C、D類醫療器材都可採取完整評估和簡要評估；部分C、D類醫療器材可採取快速評估；部分等級B、C類醫療器材可採取立即評估。

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.

【參考連結】

https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

HLF-SG-20
外國公司要到新加坡銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：

不需要營業特許證，但須以當地公司名義向HSA申請批發許可執照（Wholesaler’s license）。
持有此項執照方可在新加坡境內供應醫療器材。不過，對零售商供應醫療器材，則不需持有批發許可執照。

1.申請方式：

MEDICS網站提出線上申請。

2.申請文件：提交質量管理體系 (QMS) 的以下文件之一：

．ISO 13485證書(範圍必須包括醫療器材的進口、儲存和/或分銷)。

．GDPMDS 證書(該證書需要由新加坡認可委員會（SAC）認可的認證機構頒發)。

．GDPMDS豁免聲明（僅用於再出口或非臨床用途的進口）。

．質量管理體系符合性聲明（僅適用於處理 A 類醫療器材的公司）。

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).

【參考連結】

https://www.sac-accreditation.gov.sg/

https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

HLF-SG-25

假如需要辦理，請問新加坡有專業服務公司可以協助辦理醫療器材公司營業許可證？

Evershine RD：

不需要營業許可證。

HLF-SG-30
外國公司要到新加坡銷售醫療器材，可以指派新加坡公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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，不需要營業特許證，但須以當地公司並向HSA申請批發許可執照（Wholesaler’s license）。
持有此項執照方可在新加坡境內供應醫療器材。不過，對零售商供應醫療器材，則不需持有批發許可執照。

1.申請方式：

MEDICS網站提出線上申請。

2.申請文件：提交質量管理體系 (QMS) 的以下文件之一：

．ISO 13485證書(範圍必須包括醫療器材的進口、儲存和/或分銷)。

．GDPMDS 證書(該證書需要由新加坡認可委員會（SAC）認可的認證機構頒發)。

．GDPMDS豁免聲明（僅用於再出口或非臨床用途的進口）。

．質量管理體系符合性聲明（僅適用於處理 A 類醫療器材的公司）。

醫療器材不良事件報告

所有從事醫療器材交易的公司，包括進口商、製造商、供應商和註冊人，都必須報告其產品的不良事件。

任何符合下列三個基本報告標準的不良事件 (AE) 均被視為可報告：

1. 發生了 AE（或潛在的 AE）。

2. 醫療設備與 AE 相關聯。

3. AE 導致以下結果之一：

．成為對公眾健康的嚴重威脅。

．患者、用戶或其他人的死亡。

．患者、使用者或其他人的健康狀況嚴重惡化。

．最初的 AE 沒有死亡或重傷，但如果 AE 再次發生，可能會導致患者、用戶或其他人死亡或重傷。

如何報告

不良事件的初步報告應包含盡可能詳細的信息，如果一個可報告的 AE 涉及多個經銷商，則每個經銷商都必須提交自己的報告。

報告流程

通過電子郵件提交醫療器材經銷商強制性醫療器材不良事件報告表。

何時報告

醫療器材公司，包括產品註冊人、製造商、進口商和供應商，必須報告與其所經營的醫療器材相關的任何不良事件。
必須向我們報告以下與醫療器材相關的AE

1. 嚴重威脅公眾健康：48小時

2. 死亡：10天

3. 健康狀況嚴重惡化：10天

4. 如果不良事件再次發生，可能導致死亡或重傷：30天

注意：

1.一旦公司的任何人員（包括銷售代表）了解 AE情況，報告的時間就開始了。如果不確定 AE 是否可報告，仍應在規定的時間範圍內提交報告。

2.醫療器材經銷商應在初始報告後 30 天內更新內容，詳細說明對不良事件的調查，必要時可要求提供後續報告。

3.發生在新加坡境外但醫療器材也在新加坡供應的不良事件不需要報告。只有當這些醫療器材的註冊或許可條件要求，或者收到要求提供不良事件信息的通知時，才需要報告。

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.

【參考連結】

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
外國公司銷售到新加坡醫療器材本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

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。醫療器材只有新加坡本地的公司可以申請產品註冊。

海外的製造商有以下3種可能性在新加坡註冊其醫療器材：

1. 在本地設立子公司來進行註冊。

2. 指定擁有經銷商執照、醫療器材良好分銷實踐認證(GDPMDS) 和註冊賬戶的當地進口商或批發商通過MEDICS 註冊醫療器材。

3. 委託獨立第三方對醫療器材進行註冊

B、C、D類產品註冊：未經任何海外參考監管機構事先批准的醫療器材必須經過全面評估，包含以下內容。

1. 東盟共同提交檔案模板 (CSDT)

．執行摘要

．基本原則清單

．符合性聲明

．設備說明

．設計驗證和確認文件的詳細信息：臨床前研究的完整報告，例如物理測試數據、生物相容性研究、動物研究以及軟件驗證和確認研究

．計量要求

．滅菌驗證

．保質期研究和預計使用壽命

．臨床評估報告，包括所引用研究的出版物和完整報告

．設備標籤

．風險分析

．生產場所和滅菌場所的名稱和地址

．以下至少一項質量管理體系的證明：ISO 13485、符合美國 FDA 質量體係法規、日本厚生勞動省條例 169

．製造工藝流程圖

．可能需要進一步的臨床數據來支持設備在其正常使用之外的其他標記用途

2. 授權書

3. 醫療器材配置清單

產品標籤與包裝

1.需要符合規範，於產品註冊時審查。

2.產品標籤必須是英文

3.標籤上顯示的基本信息應以人類可讀的格式提供，但可以通過機器可讀的格式進行補充，例如射頻識別 (RFID) 或條形碼。

4.標籤上的所有字符必須足夠大且印刷清晰。

標籤的一般要素

1. 產品所有者的姓名、聯繫方式（地址/電話號碼/電子郵件地址）。

2. 醫療器材的商品或品牌名稱，應提供在設備包裝和使用說明上，以幫助用戶識別設備以及與設備相關的使用說明。

3. 用戶識別設備的足夠詳細信息，應在設備包裝上提供，以幫助用戶將設備與其他設備/類型區分。

4. 應在設備包裝上提供批號/批號（例如一次性設備或試劑）或序列號（例如電動醫療設備）的指示，以便採取適當的行動來追踪和召回設備。

5. 在設備包裝上提供明確指示設備可以安全使用的日期，至少以年、月表示，例如，在提供無菌、一次性設備或試劑的設備。

6. 如果標籤和/或 IFU 上指定了設備的預計使用壽命，則最終用戶應在設備的整個使用過程中清楚地識別製造日期。這是為了幫助最終用戶跟踪設備的剩餘使用壽命。

7. 明確標示截止日期。

8. 適用的任何特殊儲存和/或處理條件的說明，包括第一次打開主容器後的儲存條件、保質期，以及工作溶液的儲存條件、穩定性。

9. 使用說明的發布日期或最新版本，以及識別號。

10. 如果醫療器材裝在一個包裝中，而包裝內的物品不是很明顯，則應說明包裝內含的物品，並以適合醫療器材的術語表示，例如尺寸、淨重、長度、體積或單位數。

11. 使用醫療器材的任何特殊操作說明。

12. 如果設備的產品所有者打算將設備與其他醫療設備/專用軟體一起安裝或連接，則應提供識別此類設備的信息，和/或對醫療器材和設備組合的任何已知限制信息，以便獲得安全組合，

13. 驗證設備是否正確安裝以及是否可以正確、安全運行所需的信息，包括性質的詳細信息，預防性、定期維護的頻率，任何質量控制，消耗性組件的更換以及校準所需的校準，確保設備在其預期壽命期間正常、安全地運行。

14. 產品所有者預期的性能和任何不良作用。

15. 用戶正確使用設備所需的規格，例如如果設備具有測量功能，設備設計達到的準確度。

16. 設備用戶和/或第三方特殊設施、特殊培訓或特定資格的任何要求。

17. 供非專業人士使用的設備，用戶應諮詢醫療保健專業人員的情況。

18. 可能適用於醫療器材使用的任何禁忌症、警告、限製或預防措施。

19. 任何需要立即引起醫療器材用戶注意的警告、限制或預防措施，並在適當的情況下提請任何其他人注意（例如，注意 – 輻射危險）應提供在設備或其包裝上。

20. 與設備中包含的材料有關的注意事項，例如：患者或使用者的致敏或過敏反應。

21. 警告、預防措施和/或在設備發生故障或性能發生變化時應採取的措施。

22. 在特定的診斷調查、評估、治療或使用過程中，針對設備的合理可預見的干擾風險（例如設備發出的電磁干擾影響其他設備）。

23. 關於患者或用戶暴露於合理可預見的環境條件或由於醫療設備的所有或任何物理特徵（如磁場、外部電和電磁效應、靜電放電、壓力或壓力變化、溫度、濕度、加速度。

24. 與設備、附件，以及一起使用的耗材（如果有）的相關警告或預防措施，應涵蓋與設備相關的任何特殊或不尋常的風險，包括：

．感染或微生物危害（例如外植體、針頭或外科設備被人源的潛在感染物質污染）

．環境危害（例如，釋放潛在危險輻射水平的電池或材料）

．物理危害（例如，銳器）

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)

【參考連結】

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/gn-23-r1-1-guidance-on-labelling-for-medical-devices(20mar-pub).pdf

https://www.hsa.gov.sg/medical-devices/registration/overview

HLF-SG-45

HLF-SG-50
外國公司可以用自己名義申請辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
醫療器材包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？

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，醫療器材只有新加坡本地的公司可以申請產品註冊，除非符合以下條件:
海外的製造商有以下3種可能性在新加坡註冊其醫療器材：
1. 在本地設立子公司來進行註冊。
2. 指定擁有經銷商執照、醫療器材良好分銷實踐認證(GDPMDS) 和註冊賬戶的當地進口商或批發商通過MEDICS 註冊醫療器材。
3. 委託獨立第三方對醫療器材進行註冊
B、C、D類產品註冊：未經任何海外參考監管機構事先批准的醫療器材必須經過全面評估，包含以下內容。

1. 東盟共同提交檔案模板 (CSDT)

．執行摘要

．基本原則清單

．符合性聲明

．設備說明

．設計驗證和確認文件的詳細信息：臨床前研究的完整報告，例如物理測試數據、生物相容性研究、動物研究以及軟件驗證和確認研究

．計量要求

．滅菌驗證

．保質期研究和預計使用壽命

．臨床評估報告，包括所引用研究的出版物和完整報告

．設備標籤

．風險分析

．生產場所和滅菌場所的名稱和地址

．以下至少一項質量管理體系的證明：ISO 13485、符合美國 FDA 質量體係法規、日本厚生勞動省條例 169

．製造工藝流程圖

．可能需要進一步的臨床數據來支持設備在其正常使用之外的其他標記用途

2. 授權書

3. 醫療器材配置清單

產品標籤與包裝

1.需要符合規範，於產品註冊時審查。

2.產品標籤必須是英文

3.標籤上顯示的基本信息應以人類可讀的格式提供，但可以通過機器可讀的格式進行補充，例如射頻識別 (RFID) 或條形碼。

4.標籤上的所有字符必須足夠大且印刷清晰。

標籤的一般要素

1. 產品所有者的姓名、聯繫方式（地址/電話號碼/電子郵件地址）。

2. 醫療器材的商品或品牌名稱，應提供在設備包裝和使用說明上，以幫助用戶識別設備以及與設備相關的使用說明。

3. 用戶識別設備的足夠詳細信息，應在設備包裝上提供，以幫助用戶將設備與其他設備/類型區分。

4. 應在設備包裝上提供批號/批號（例如一次性設備或試劑）或序列號（例如電動醫療設備）的指示，以便採取適當的行動來追踪和召回設備。

5. 在設備包裝上提供明確指示設備可以安全使用的日期，至少以年、月表示，例如，在提供無菌、一次性設備或試劑的設備。

7. 明確標示截止日期。

8. 適用的任何特殊儲存和/或處理條件的說明，包括第一次打開主容器後的儲存條件、保質期，以及工作溶液的儲存條件、穩定性。

9. 使用說明的發布日期或最新版本，以及識別號。

11. 使用醫療器材的任何特殊操作說明。

14. 產品所有者預期的性能和任何不良作用。

15. 用戶正確使用設備所需的規格，例如如果設備具有測量功能，設備設計達到的準確度。

16. 設備用戶和/或第三方特殊設施、特殊培訓或特定資格的任何要求。

17. 供非專業人士使用的設備，用戶應諮詢醫療保健專業人員的情況。

18. 可能適用於醫療器材使用的任何禁忌症、警告、限製或預防措施。

20. 與設備中包含的材料有關的注意事項，例如：患者或使用者的致敏或過敏反應。

21. 警告、預防措施和/或在設備發生故障或性能發生變化時應採取的措施。

22. 在特定的診斷調查、評估、治療或使用過程中，針對設備的合理可預見的干擾風險（例如設備發出的電磁干擾影響其他設備）。

24. 與設備、附件，以及一起使用的耗材（如果有）的相關警告或預防措施，應涵蓋與設備相關的任何特殊或不尋常的風險，包括：

．感染或微生物危害（例如外植體、針頭或外科設備被人源的潛在感染物質污染）

．環境危害（例如，釋放潛在危險輻射水平的電池或材料）

．物理危害（例如，銳器）

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.

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

．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

．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

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).

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.

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.

7. Clearly mark the due date.

9. Date or latest version of the instructions for use, and identification number.

11. Any special handling instructions for using the medical device.

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.

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.

． 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)

【參考連結】

https://www.hsa.gov.sg/medical-devices/guidance-documents

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/gn-23-r1-1-guidance-on-labelling-for-medical-devices(20mar-pub).pdf

HLF-SG-55

HLF-SG-60
經過核准登記的醫療器材，進口到新加坡要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：
需要當地公司名義申請進口商許可證，由進口商許可證持有者名義進口醫療器材。
進口商許可證（Importer’s licence）

1.申請方式：

MEDICS網站提出線上申請。

2.申請文件：提交質量管理體系 (QMS) 的以下文件之一：

．ISO 13485證書(範圍必須包括醫療器材的進口、儲存和/或分銷)。

．GDPMDS 證書(該證書需要由新加坡認可委員會（SAC）認可的認證機構頒發)。

．GDPMDS豁免聲明（僅用於再出口或非臨床用途的進口）。

．質量管理體系符合性聲明（僅適用於處理 A 類醫療器材的公司）。

．如果不進口任何 A 類醫療器材，請提交不經營 A 類醫療器材聲明。

海關進口許可證：

新加坡對進口商品檢驗檢疫的標準和程序十分嚴格。負責進口醫療器材商品檢驗的部門是HSA。

1. 註冊入口網站的帳戶
https://www.tradenet.gov.sg/TN41EFORM/tds/sp/splogin.do?action=init_acct

．需使用HSA產品代碼提交進口申報，並提供相關許可和/或批准資料。

．產品代碼：HSAHP、HSAIFRSA

2. 指定報關代理人(新加坡物流協會/新加坡航空貨運代理協會)或由進口商許可證持有者申報。

．必須與新加坡海關負責銀行 GIRO (IBG)綁定以直接從您的銀行賬戶向新加坡海關支付新加坡海關提供的服務的關稅、稅款、費用、罰款和其他費用。

．如果沒有在新加坡海關持有 IBG，關稅和 GST 將從您的申報代理的 IBG 中扣除。

3. 提供安全保障

．需要為涉及應課稅貨物的交易、為批准目的臨時進口貨物以及經營特許經營場所（如特許倉庫和消費稅工廠）提供擔保。

．提供的擔保應採用銀行擔保、財務公司擔保或保證金的形式。

4. 獲得海關進口許可證

．申请必須透由TradeNet提交 (TradeNet軟體、政府應用程序)

．每份許可證的申請費用通常是2.88新元，不包含報關代理服務費等，如委託報關公司代理，可以查閱其收取的服務費用。

文件內容

．申請公司(須以公司名義報關，如為個人可以委託代辦公司申請)、郵政編碼、地址、電話、傳真、行業

．聯繫人、聯繫方式、電話、傳真、電子郵件

．計費管理員(通常是主管或財務人員)姓名、身分證/護照號碼、聯繫方式、電子郵件

．付款方式

．簽章

5. 準備貨物清關文件

．提供證明文件，包括發票、包裝清單及提單/空運提單

．集裝箱貨物所需文件

通過海運進口集裝箱貨物，無需向入境口岸的檢查站人員出示海關許可證和證明文件的打印副本。

通過空運或陸運進口集裝箱貨物，需要出示海關許可證以及發票、裝箱單和提單/空運提單等證明文件，向檢查站官員核實。

．常規貨物所需文件

對於常規貨物，請在貨物清關時將貨物、海關通行證打印件、發票、裝箱單、提單/空運單等證明文件交給口檢人員核對。

．保留貿易文件

購買、進口、銷售或出口貨物有關的相關證明文件自許可證申請批准之日起保留 5 年。

6. 提交申報時，請遵守以下要求：

．使用適用的 HSA 產品代碼，在單獨的項目序列號上聲明每個產品。

．產品代碼計量單位 (UOM) 必須與聲明的 HS UOM 匹配。

．即使產品使用相同的 HS 編碼，也不要為每個商品序列號申報超過一件商品。

．聲明產品標籤上的完整產品名稱。

．在 CA/SC 代碼字段中聲明相關的許可/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.

【參考連結】

https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

https://www.customs.gov.sg/businesses/importing-goods/overview

HLF-SG-70
新加坡醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

DPMDS SS620認證：質量管理體系要求

1.一般要求

建立的質量管理體系應足夠穩健，以滿足外部和內部考慮，例如法規要求的變化、客戶反饋、關鍵人員、設施的變化等。

2.文件要求

程序中所需的結構、詳細程度應根據組織的需要進行調整。程序或說明可以任何形式（文本、圖形或視聽）或媒介呈現。

．文件控制：應有適當的控制以確保文件的準確性、可用性、易讀性和可追溯性。

．記錄控制：組織應保留所有所需的記錄，以說明其遵守 SS GDPMDS 中的各種相關條款。在使用電子記錄系統代替紙質系統的情況下，所使用的系統應具有內置的製衡機制，以確保記錄的完整性並防止未經授權的輸入。該系統還應包含用於跟踪更改的審計跟踪。

3. 管理責任

．組織應在質量管理體系中記錄工作描述，包括關鍵職責和權限。

．管理代表：管理代表的任命應記錄在案，例如在站點主文件或正式任命信中。只有一名管理層成員被授權為組織的管理層代表。在管理代表缺席的情況下，可以任命一名副手。管理者代表履行的其他職責和職能與與質量管理體系相關的職責和職能之間不能有利益衝突。

4. 管理評審

．最高管理者應定期審查質量管理體系，至少每年一次，以確保質量管理體系保持有效。

．審核輸入、輸出

．管理記錄可以採用適合組織的任何形式，包括正式的會議記錄或會議記錄，應以紙本或電子方式製作、分發和存儲。管理評審的記錄應包括參與評審的人員的身份、評審日期和所有評審輸入和輸出SS GDPMDS 中列出的方面。這包括對要採取的任何糾正或預防措施的描述。

．對於確定的任何行動，應確定此類行動的責任、資源、目標完成日期等。

5.資源管理

．人員：組織應考慮參與醫療器材分銷的人員的經驗、資格、能力和能力。在質量體系內工作的人員需要一定程度的能力或培訓（內部或外部）才能正確執行任務。培訓可以採取在職培訓/主管指導、指導簡報、課程、講習班等形式。
對處理某些類別的物質/材料（如化學、生物、輻射發射或能源）的人員可能需要特殊培訓組件或產品，以及需要冷鏈管理的組件或產品。

．培訓：人員培訓應根據人員的角色和職責進行調整。

6. 場地和設施

．儲存、倉儲和庫存處理

收貨區應保護貨物在卸貨過程中免受外部環境（例如雨）的損壞。接收區應與存儲區分開。用於儲存、倉儲和庫存處理的場所應具有足夠的安全性，以防止未經授權的訪問和盜用醫療器材。場所應保護醫療設備免受污染和變質，包括防止過熱或過度暴露在陽光直射下。儲存區域應有足夠的照明和通風。不應允許吸煙、進食和飲水。應該有足夠的存儲區域，並在適用的情況下，物理上分開的區域，以便有序地隔離醫療器材。應為隔離、可銷售庫存、過期、拒收/損壞、召回和退回的醫療器材設立指定區域。替代方法如果得到證實，可以考慮隔離，以防止混淆。

．適用於醫療器材的儲存溫度應根據製造商的建議，通常在標籤上標明特別的存儲要求。

．應以適當的預定時間間隔測量存儲區域的溫度，以顯示當天的最高和最低溫度並記錄下來，還應進行濕度測量。溫度監測器應位於最有可能出現波動的區域。

．需要特殊儲存條件（即 8°C 及以下的儲存條件）的醫療器材需要冷鏈管理。

．清潔度：存儲區域應保持清潔，並應定期清除廢物。醫療器材應遠離地面存放並保持適當的間距，以便進行清潔和檢查。托盤應妥善保養並保持良好的清潔狀態。應採取充分的預防措施，防止溢出或破損、污染和交叉污染。

．害蟲防治：應設置儲存區以防止昆蟲、囓齒動物和其他害蟲/動物進入。需要保留的記錄示例包括第三方害蟲防治公司出具的服務報告、內部誘餌更換記錄、害蟲類型和數量。

．庫存周轉：應保存全部批次/批號/序列號或同等數量的所有進出醫療器材記錄，醫療器材的定期庫存核對應通過將實際庫存數量與記錄的庫存數量進行比較。

．醫療器材的交付：應制定程序將所有醫療器材從發佈點到交付點安全、可靠的交付。

7.安裝和維修

．安裝活動：應建立執行和驗證安裝是否滿足規定要求的說明和程序。只有經過適當培訓和合格的人員才能進行醫療設備的安裝。

．服務活動：應制定執行和驗證服務（包括修理和維護）是否滿足規定要求的說明和程序。只有經過適當培訓和合格的人員才能對醫療設備進行維修。

．校準：用於測量和監測的儀器（例如溫度、濕度和電流）應定期校準或驗證其準確性，並記錄和保存此類校准或驗證的結果。校準應由合格人員或相關方執行。

．醫療器材的退貨：任何退回組織的產品都應被視為不合格產品，在確定處置評估之前，退回的醫療器材只能作為可銷售庫存，並由授權人員進行質量重新評估。

．醫療器材的處置：不符合規格的醫療器材（例如過期、污染、損壞、有缺陷等）應妥善處置。應建立控制以確保用於處置的醫療器材無法再供應，並且按照程序和製造商的說明（如果有）進行處置。處置方法可能包括但不限於焚燒、返還給產品所有者等。

8. 認證機構：需要由新加坡認可委員會（SAC）認可的認證機構頒發

https://www.sac-accreditation.gov.sg/

9. 網頁：https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

醫療器材產品註冊需繳交技術文件，包含以下內容(Technical Reference Documents)：

1. 證明符合性的相關基本原則和方法

2. 設備說明

．設備描述和功能

．預期用途

．適應症

．使用說明

．禁忌症

．警告

．預防措施

．潛在的不利影響

．替代

．材料

．其他相關規範

．其他描述性信息

3. 設計驗證和確認文件摘要

．臨床前研究

．臨床證據

4. 設備標籤

．設備及其包裝上的標籤

．使用說明

5. 風險分析結果

6. 製造商信息、製造工藝

7. 參考文獻

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

【參考連結】

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
外國子公司進口醫療器材後，如果委託新加坡的經銷商銷售，經銷商需要醫療器材營業許可證嗎？
假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？

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：
須為當地公司並向HSA申請批發許可執照（Wholesaler’s license）。持有此項執照方可在新加坡境內供應醫療器材。不過，對零售商供應醫療器材，則不需持有批發許可執照。

1.申請方式：

MEDICS網站提出線上申請。

2.申請文件：提交質量管理體系 (QMS) 的以下文件之一：

．ISO 13485證書(範圍必須包括醫療器材的進口、儲存和/或分銷)。

．GDPMDS 證書(該證書需要由新加坡認可委員會（SAC）認可的認證機構頒發)。

．GDPMDS豁免聲明（僅用於再出口或非臨床用途的進口）。

．質量管理體系符合性聲明（僅適用於處理 A 類醫療器材的公司）。

醫療器材不良事件報告

所有從事醫療器材交易的公司，包括進口商、製造商、供應商和註冊人，都必須報告其產品的不良事件。

任何符合下列三個基本報告標準的不良事件 (AE) 均被視為可報告：

1. 發生了 AE（或潛在的 AE）。

2. 醫療設備與 AE 相關聯。

3. AE 導致以下結果之一：

．成為對公眾健康的嚴重威脅。

．患者、用戶或其他人的死亡。

．患者、使用者或其他人的健康狀況嚴重惡化。

．最初的 AE 沒有死亡或重傷，但如果 AE 再次發生，可能會導致患者、用戶或其他人死亡或重傷。

如何報告

不良事件的初步報告應包含盡可能詳細的信息，如果一個可報告的 AE 涉及多個經銷商，則每個經銷商都必須提交自己的報告。

報告流程

通過電子郵件提交醫療器材經銷商強制性醫療器材不良事件報告表。

何時報告

1. 嚴重威脅公眾健康：48小時

2. 死亡：10天

3. 健康狀況嚴重惡化：10天

4. 如果不良事件再次發生，可能導致死亡或重傷：30天

注意：

1.一旦公司的任何人員（包括銷售代表）了解 AE情況，報告的時間就開始了。如果不確定 AE 是否可報告，仍應在規定的時間範圍內提交報告。

2.醫療器材經銷商應在初始報告後 30 天內更新內容，詳細說明對不良事件的調查，必要時可要求提供後續報告。

3.發生在新加坡境外但醫療器材也在新加坡供應的不良事件不需要報告。
只有當這些醫療器材的註冊或許可條件要求，或者收到要求提供不良事件信息的通知時，才需要報告。

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

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.

【參考連結】

https://www.hsa.gov.sg/medical-devices/adverse-events

https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

HLF-SG-85

各國醫療器材登記法規問答集

**請注意下列事項：
以上內容為永輝研發及教育中心 (簡稱:永輝RD)於2021年10月摘要。
隨著時間推移，法規會發生變化，不同情況會有不同的選擇。
在選擇選項之前，請與我們聯系或諮詢您信任的專業人士。
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新加坡與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。除了提供外資公司登記外，在雲會計和薪資系統的支持下,永輝擔任您的本地內部會計角色，承擔了會計,稅務,薪資等法規遵循服務。

新加坡主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。新加坡新加坡與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。

申請適用租稅協定第7條營業利潤免稅申請服務，新加坡公司支付費用給台灣母公司的零扣繳稅率申請。當新加坡公司（作爲付款人）向台灣母公司(收款人)支付服務費時，由於新加坡與臺灣簽訂了 DTA （避免雙重徵稅協定），而且在台灣母公司在新加坡沒有常設機構(non-PE) ，我們將根據 DTA 提供零稅率豁免申請服務。

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