Manufacturers of certain medium to high risk 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:
1) U.S. Food and Drug Administration (FDA)
2) EU Notified Body
3) Health Canada
4) Australia’s Therapeutic Goods Administration (TGA)
5) 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.
In addition to Health Sciences Authority (HSA) certification, registration and licensed distribution requirements, the supply and use of medical devices in Singapore may be subject to additional regulations, such as the provisions of the Private Hospitals and Medical Clinics Act, and the Radiation Protection Act. Requirements can differ depending on the type of medical device under consideration.
A key requirement facing companies seeking to import, distribute or sell medical devices in Singapore is the requirement to establish and maintain a quality management system that meets the provisions set forth in 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 ISO 13485. 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.