UNDERSTANDING SINGAPORE'S HEALTH PRODUCTS ACT FOR MEDICAL DEVICES
The Singapore Health Products Act of 2007 requires that all medical devices used to treat hospital and clinic patients be certified by an accredited Certification Assessment Body (CAB), registered in the Singapore Medical Device Information and Communication System (MEDICS), and distributed under an “establishment license”. Hospitals and clinics are prohibited from using any medical devices that have not been certified, registered and legally distributed under license. These requirements are designed to ensure the quality and integrity of all medical devices throughout the entire distribution process.
WHY IS CAB CERTIFICATION IMPORTANT?
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:
- 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.
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.
CERTIFICATION OF GDPMDS
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.
WHY CHOOSE TÜV SÜD MALAYSIA
TÜV SÜD PSB has been accredited by the Singapore Accreditation Council as an approved CAB for medical devices, and is qualified to conduct product safety testing for a variety of medical devices including active implantable medical devices. TÜV SÜD PSB can also review and certify a company’s quality management system consistent with the requirements of Singapore’s GDPMDS standard.
OUR SERVICES AT A GLANCE
- Product testing and certification support - TÜV SÜD PSB is an accredited CAB for medical devices in Singapore, and authorised to certify medical devices under the HSA.
- 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 testing and certifying medical devices 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.