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What are Singapore medical device regulations
Health Sciences Authority (HSA) regulates medical devices in Singapore under Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.
HSA requires companies to obtain a dealer’s license before manufacturing, importing or supplying medical devices. All medical devices will require registration with HSA before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by HSA.
Starting 1 Jan 2025, only ISO 13485 issued by SAC accredited CABs or MDSAP be accepted for Manufacturer’s license application with HSA. The manufacturer must ensure and maintain objective evidence to establish that the manufacture of the medical device complies with the requirements of ISO 13485, including the HSA Regulatory Requirements.
A key requirement facing companies seeking to import, distribute or sell medical devices in Singapore is to establish and maintain a quality management system that meets the HSA’s “Good Distribution Practice for Medical Devices” (GDPMDS) standard. GDPMDS provisions are similar in scope to those found in international quality management systems standards, such as SAC ISO 13485. SAC ISO 13485 certification by TÜV SÜD can serve as a substitute to GDPMDS certification if "storage and distribution" is covered in the scope of certification.
HSA requires companies to obtain a dealer’s license before manufacturing, importing or supplying medical devices. All medical devices will require registration with HSA before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by HSA.
Starting 1 Jan 2025, only ISO 13485 issued by SAC accredited CABs or MDSAP be accepted for Manufacturer’s license application with HSA. The manufacturer must ensure and maintain objective evidence to establish that the manufacture of the medical device complies with the requirements of ISO 13485, including the HSA Regulatory Requirements.
A key requirement facing companies seeking to import, distribute or sell medical devices in Singapore is to establish and maintain a quality management system that meets the HSA’s “Good Distribution Practice for Medical Devices” (GDPMDS) standard. GDPMDS provisions are similar in scope to those found in international quality management systems standards, such as SAC ISO 13485. SAC ISO 13485 certification by TÜV SÜD can serve as a substitute to GDPMDS certification if "storage and distribution" is covered in the scope of certification.
Why CAB certification is Important
Manufacturers of certain medical devices may qualify for an abridged product evaluation if the device has been evaluated and approved by one of the following national regulatory bodies:
- U.S. Food and Drug Administration (FDA)
- EU Notified Body
- Health Canada
- Australia’s Therapeutic Goods Administration (TGA)
- Japan’s Ministry of Health, Labour and Welfare (MHLW)
Devices submitted for product evaluation in Singapore under the abridged evaluation process must be identical to those approved by the reference regulatory body.
How TÜV SÜD can help you with Singapore medical device regulations
TÜV SÜD is accredited by the Singapore Accreditation Council (SAC) as an approved CAB for medical devices.
We are qualified to review and certify a company’s quality management system complies with the requirements of Singapore’s GDPMDS standard and the SAC ISO 13485 which including the Health Products Act (HPA) and HSA regulatory requirements. Our quality management system certifications, audits and factory inspections are consistent with most international regulations and standards. This allows clients to enjoy the benefits of coordinated inspections and audits with reduced risk and higher level of quality assurance, while reducing time of registration.
By using accredited CABs, it provides a marketing opportunity to the company, it also boosts the company’s image by having certification from the reliable CABs. This instils confidence in the company’s customers and stakeholders alike.
We are qualified to conduct biocompatibility studies and product safety testing for various medical devices with our ISO 17025 and GLP certified laboratories.
We are a trusted partner for companies ranging from global manufacturers to regional and local firms. Our extensive international network makes us an effective partner for manufacturers seeking global market access for their products. A Regulatory Affairs, Foreign Affairs and Clinical Centre of Excellence adds to our expertise.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees.
What our Singapore medical device regulations service includes
- QMS Review and Certification – TÜV SÜD PSB is accredited CAB by Singapore Accreditation Council (SAC) to certify quality management system for medical device and other quality management system.
- GDPMDS review and certification – TÜV SÜD PSB is also qualified to certify a company’s quality management systems, consistent with the provisions of Singapore’s GDPMDS standard.
- Other testing and certification services – In addition to review and certification of QMS to HSA requirements, TÜV SÜD PSB can also provide product safety and EMC testing for active medical devices for compliance with other relevant regulations and standards.
