Importers and wholesalers dealing with medical devices in Singapore should develop a Quality Management System (QMS) that conforms to the requirements of the Good Distribution Practice for Medical Devices (GDPMDS). GDPMDS ensures that companies dealing
with medical devices have quality management systems in place to maintain devices quality throughout the distribution process.
GDPMDS for medical devices
If you are applying for an Importer or Wholesaler licence, please ensure you have obtained a certification to GDPMDS from certification bodies accredited by the Singapore Accreditation Council (SAC).
Currently, HSA accepts the following two GDPMDS certification standards. Refer to the respective Guidance Notes below to better understand these standards and how to apply them in meeting the regulatory requirements:
- Technical Specification (TS-01 R2.1)
- Singapore Standard GDPMDS SS620
Note: Certification to GDPMDS based on Singapore Standard GDPMDS SS620 will be the only acceptable option from 9 November 2020.
Class A medical devices
Companies dealing with only Class A medical devices may submit a Declaration of Conformity47 KB 47 KBto a QMS, in lieu of ISO 13485 or GDPMDS certification for the application of a importer or wholesaler licence.