Singapore: ISO13485 Certification Requirement for Medical Device Dealers

ARQon
Jul 8, 2021
1 min read

Local companies who manufacture, import, or supply medical devices by wholesale are required to be licensed by HSA. The type of dealer license they need to possess depends on the company’s activities.

Good Distribution Practise for Medical Devices in Singapore (GDPMDS) Certification

All GDPMDS certification must be performed by a 3rd party certification body (CB) who is subjected to witnessed assessments by HSA and accredited by the Singapore Accreditation Council (SAC).

ISO13485 Certification

All CBs that issue ISO13485 for local medical device regulatory purpose need to get themselves accredited by SAC. Similarly for GDPMDS certification, HSA will implement a witnessed assessment program.