Singapore Medical Devices Registration QA
Email: sin4ww@evershinecpa.com
Singapore CPA Lau Wei-Koon, speak in both English and Chinese
215 Henderson Road #03-03 Henderson Industrial Park Singapore 159554
HLF-SG-10
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：
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
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
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：
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
假如需要辦理指派新加坡公司擔任營業代理人，請問新加坡有專業服務公司可以協助？
Evershine RD：
Pharmaforte
YMS
HLF-SG-40
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：
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/medical-devices/registration/overview
HLF-SG-45
請問在新加坡有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
AZ
https://www.xn--az-q24cq15h.com/
TUV SUD PSB Pte Ltd
HLF-SG-50
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：
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)
【參考連結】
https://www.hsa.gov.sg/medical-devices/guidance-documents
HLF-SG-55
請問在新加坡有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
TUV SUD PSB Pte Ltd
BSI
https://www.bsigroup.com/en-SG/Our-services/Certification/
HLF-SG-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
新加坡醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
須為國際認證的ISO 13485 證書，或由新加坡認可委員會（SAC）認可的認證機構頒發之GDPMDS 證書(HLF-SG-77)：
LRQA
DNV
CM
https://www.cm-consulting.com.tw/
KIND
TUV
Intertek
https://www.intertek-twn.com/frontend/default.aspx?lang=C
DEKRA
https://www.dekra.com.tw/tc/home/
HLF-SG-77
請問在新加坡有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
新加坡認可委員會（SAC）認證機構：
A-Europe
BV
Guardian Independent Certification Pte Ltd
ISOCERT PTE. LTD.
SGS International Certification Services Singapore Pte Ltd
SOCOTEC CERTIFICATION SINGAPORE PTE. LTD.
http://www.socotec-certification-international.sg
TRANSPACIFIC CERTIFICATIONS (SINGAPORE) PTE. LTD.
TUV SUD PSB Pte Ltd
BSI
https://www.bsigroup.com/en-SG/Our-services/Certification/
HLF-SG-80
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：
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.
【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
請問在新加坡有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
Rajah & Tann
Drew & Napier
MPS
https://www.medicalprotection.org/malaysia
Contact Us
Singapore Evershine BPO Service Limited Corp.
E-mail: sin4ww@evershinecpa.com
Singapore CPA Lau Wei-Koon, speak in both English and Chinese
215 Henderson Road #03-03 Henderson Industrial Park Singapore 159554
or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), email to HQ4sin@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
linkedin address: Dale Chen
Additional Information
Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico
Other cities with existent clients:
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Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
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Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please send email to HQ4sin@evershinecpa.com
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