Companies involved in the importation, exportation, and distribution of medical devices in Malaysia must comply with the Good Distribution Practice for Medical Devices (GDPMD) standard. This certification is a mandatory requirement under the Medical Device Act 2012 (Act 737) and is essential before applying for an Establishment License from the Medical Device Authority (MDA).
This article provides an updated 2025 step-by-step guide to help businesses understand the certification process and prepare effectively.
1. Understand GDPMD Requirements
GDPMD ensured that medical devices are consistently stored, transported, and distributed under safe and controlled conditions. The requirements cover:
- Quality management system (QMS).
- Proper storage and handling.
- Distribution records and traceability.
- Complaint management and recall procedures.
- Employee roles and responsibilities.
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2. Conduct a Gap Analysis
A gap analysis helps identify the difference between your current practices and GDPMD requirements. Common gaps include:
- Lack of documented procedures.
- Inadequate monitoring of temperature and humidity.
- Weak traceability and record-keeping.
3. Develop and Implement a Quality Management System (QMS)
A documented QMS is required to demonstrate compliance. Essential elements include:
- Standard Operating Procedures (SOPs).
- Defined responsibilities of staff.
- Documented records for storage, distribution, and transportation.
4. Provide Employee Training
Staff involved in handling medical devices must be trained to ensure consistent compliance. Training typically covers:
- SOP implementation.
- Stock handling and record-keeping.
- Procedures for complaints and product recalls.
5. Conduct an Internal Audit
Before applying for certification, companies should perform an internal audit to evaluate compliance and correct any non-conformities. This reduces the risk of issues during the external audit.
6. Engage an MDA-Recognized Certification Body
GDPMD certification must be obtained from a certification body recognized by the Medical Device Authority (MDA). Using a non-recognized body will result in the certificate being invalid.
For your reference, please visit the following website: https://mdar.mda.gov.my/frontend/web/index.php?r=carian-cab
7. Undergo the Certification Audit
The certification audit usually involves two stages:
- Stage 1: Document review
- Stage 2: On-site audit to verify implementation.
Auditors will assess whether your QMS and processes comply with GDPMD requirements.
8. Obtain GDPMD Certification
Once the audit is successfully completed, the company will be awarded the GDPMD certificate. Typically, the certificate is valid for three years, subject to annual surveillance audits. With this certificate, companies may then apply for the MDA Establishment License.
Conclusion
GDPMD certification is a legal requirement for medical device distributors in Malaysia. By following these steps, companies can ensure smooth certification, regulatory compliance, and enhanced business credibility.
At Flexly Consulting Sdn Bhd, we provide expert consultancy and training services to guide organizations through the GDPMD certification process – from initial gap analysis to documentation, training, audit preparation and internal audit. Contact us today to learn how we can support your certification journey.
