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 Singapore Standard GDPMDS SS620 from certification bodies accredited by the Singapore Accreditation Council (SAC). Refer to the Guidance below to better understand this standard and how to apply it in meeting the regulatory requirements:
- GN-33 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices564 KB
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.