In the last article, we discussed the steps to conduct medical device registration with MDA. In order to register a medical device in Malaysia, a company must first be certified with GDPMD by Conformity Assessment Body (CAB) recognized by MDA.
In this article, we will be exploring what are things a company should do in order to comply with GDPMD requirements and what are the steps to be taken to obtain the GDPMD certification in Malaysia. However, if this is your first time hearing about GDPMD, please click here.
Here are the 5 steps to obtain GDPMD certification in Malaysia:
Step 1: GDPMD Awareness Training
An awareness training session for the key personnel in the GDPMD Implementation Team should be provided by a registered GDPMD consultancy or training company. This awareness training is to provide sound understanding of the principles and requirements of GDPMD.
Step 2: Establishment of GDPMD Regulatory Compliance System
GDPMD documentation consists of regulatory compliance manual, procedures and supporting documents related to medical device compliance shall be prepared as controlled documents of the Regulatory Compliance System.
Step 3: Implementation of GDPMD Regulatory Compliance System
After the Regulatory Compliance System has been established, the implementation should begin. The routine operation related to distribution activities of medical devices shall be executed as the established procedures. In most cases, 2 months of implementation records are required for Certification Body Audit.
Step 4: GDPMD Internal Audit & Management Review
The overall adequacy and effectiveness of the GDPMD implementation should be checked by the appointed GDPMD consultant or company’s internal auditors. Internal auditors should perform elemental audit of selected functions and areas using audit programme and audit checklists. A Management Review is a meeting attended by the Top Management and all the personnel in the GDPMD Implementation Team to discuss and review the GDPMD system’s performance, adequacy and effectiveness.
Step 5: GDPMD Certification Body Audit
You need to appoint a MDA-registered certification body to perform your GDPMD certification audit. Initial certification is completed in two stages of audit – Stage 1 Adequacy Audit and Stage 2 Compliance Audit. Stage 1 audit will focus more on reviewing the GDPMD documentation and accessing the establishment’s readiness. After completion of Stage 1 audit, a Provisional Certificate will be awarded to the establishment. 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 Flexly Consulting Can Help?
- GDPMD Certificate – Our consultants can guide you to implement GDPMD and obtain GDPMD Certificate
- Medical Device Registration – We are fully capable to register your medical devices and interact with the MDA on your behalf.
