What Is It

GDPMD (Good Distribution Practice for Medical Devices) is a mandatory quality management certification in Malaysia. It ensures that medical devices (from surgical masks to MRI machines) are handled, stored, and distributed safely throughout the supply chain. It is required to obtain an Establishment License from the Medical Device Authority (MDA).

Who Needs It

  • Medical device Importers.
  • Medical device Distributors.
  • Authorized Representatives of foreign medical device manufacturers in Malaysia.

    • Required Documents / Preparations

  • Quality Manual: Detailing GDPMD standard operating procedures (SOPs).
  • Premise Layout: Showing clean, temperature-controlled storage rooms with pest control logs.
  • Staff Training Records: Evidence of staff training in medical device handling and recall procedures.
  • SSM Documents: Company incorporation registration.

    • Step-by-Step Procedure

    1. Appoint CAB: Appoint a registered Conformity Assessment Body (CAB - e.g., SIRIM, SGS, TÜV) to conduct the GDPMD audit. 2. Develop QMS: Establish the GDPMD Quality Management System (QMS) in your warehouse and office. 3. Stage 1 Audit (Document Review): The CAB reviews your quality manuals and SOPs. 4. Stage 2 Audit (On-Site Check): Auditors inspect your warehouse, storage conditions, temperature logs, and interview staff. 5. Corrective Actions: Resolve any non-conformities (NCRs) raised by the auditors. 6. Certificate Issuance: The CAB issues the GDPMD Certificate. You can now use this certificate to apply for the MDA Establishment License via the MeDC@St portal.

    Cost & Processing Time

  • Cost: CAB auditing fees range from RM3,500 to RM8,000 depending on warehouse size and staff count. MDA registration fee is RM2,000.
  • Processing Time: The certification process takes 3 to 6 months.

    • Where to Apply

  • Conformity Assessment Bodies (CAB): Registered auditors listed on the MDA portal (mda.gov.my) or the MeDC@St online licensing system.

    • Important Notes

  • GDPMD certificates are valid for 3 years and require yearly surveillance audits to remain active.