GDPMD

How to apply GDPMD in Malaysia?

To apply for Good Distribution Practise for Medical Devie (GDPMD) certification in Malaysia, a company must first implement a quality management system, then engage a Conformity Assessment Body (CAB) recognized by MDA to conduct a two-stage audit. After successfully passing the audits and receiving GDPMD certificate the company must apply for an MDA Establishment License through the MedDC@st portal to legally distribute medical devices in Malaysia.

Here are the 5 steps to obtain GDPMD certification in Malaysia:

Step 1: GDPMD Awareness Training
Our registered consultants provide awareness training to your company key personnel. This training ensures your team fully understands the principles and requirements of GDPMD. principles and requirements of GDPMD.

Step 2: Establishment of GDPMD Regulatory Compliance System
We help you develop your Regulatory Compliance System including manuals, procedures, and supporting documents. All maintained as controlled records in line with MDA requirements.

Step 3: Implementation of GDPMD Regulatory Compliance System
Once established, your team begins operations in compliance with the documented procedures. Certification bodies generally require 2 months of implementation records before audit.

Step 4: GDPMD Internal Audit & Management Review
Our consultants or your trained internal auditors will perform a detailed compliance audit using structured audit programmes and checklists. Internal auditors should perform elemental audit of selected functions and areas using audit programme and audit checklists. This is followed by a Management Review Meeting, where top management evaluates the system’s effectiveness and readiness.

Step 5: GDPMD Certification Body Audit
We connect you with an MDA-registered Certification Body to complete the two-stage audit:
• Stage 1: Adequacy Audit – Review of documentation and readiness. Passing this stage earns you a Provisional Certificate (used to apply for your MDA Establishment License).

• Stage 2: Compliance Audit – Assessment of system effectiveness and implementation. Successful completion results in the award of the official GDPMD Certificate. The Provisional Certificate will be used to apply for MDA establishment license. The second stage of GDPMD audit will focus more on the GDPMD implementation and system effectiveness. After passing Stage 2 audit, an official GDPMD certificate will be awarded. Book our limited FREE GDPMD Consultation to understand more.

How KayV Consulting Supports You
• GDPMD Certification – End-to-end guidance to implement and achieve GDPMD compliance.
• Medical Device Registration – We handle your medical device registration and liaise directly with the MDA on behalf of you.
• Regulatory Support – From internal audits to management reviews, we ensure you are fully prepared for certification success.