Malaysia MDA Med Dev Guidance: Guide for CABs and Medical Device Establishments
- Sharan Murugan
- Apr 1
- 3 min read
The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, "Guide for Conformity Assessment Bodies (CAB): Conducting Conformity Assessment Through Verification" and "Guide for Medical Device Establishment: Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St" to streamline the conformity assessment process for medical devices. These documents outline the roles, responsibilities, and procedures for Conformity Assessment Bodies (CABs) and medical device establishments when conducting conformity assessments through verification.
Guide for Conformity Assessment Bodies (CAB): Conducting Conformity Assessment Through Verification:
Conformity assessment is a critical procedure that ensures medical devices meet regulatory requirements for safety and performance before they can be marketed. In Malaysia, this process is governed by the Medical Device Act 2012 and related regulations. Verification is a specific type of conformity assessment that confirms the reliability of claims made by organizations regarding their products or services. The verification method is one of the approaches used by Conformity Assessment Bodies (CABs) to assess compliance, particularly for low-risk medical devices.
The verification pathway applies to medical devices classified as Class B, C, and D that meet specific criteria:
Approved by at least one recognized competent authority.
Marketed for at least one year without global safety issues (e.g., no reported deaths, serious health deterioration, or open field corrective actions).
Unchanged in design or intended purpose compared to the approved version.
Free from rejection or withdrawal by any recognized authority.
The verification process involves the following steps:
Submission of Evidence: Manufacturers provide technical documentation demonstrating compliance with EPSP.
Review by CAB: CAB evaluates submitted evidence against regulatory requirements.
On-Site Audits (if necessary): CAB conducts inspections to verify implementation of safety measures.
Issuance of Reports: CAB prepares detailed assessment reports for submission to MDA.
Certification: Upon approval, certificates are issued confirming compliance.
This guideline applies to:
Manufacturers: Responsible for compiling technical documentation.
Authorized Representatives (ARs): Acting on behalf of foreign manufacturers to submit applications in Malaysia.
To qualify for the verification pathway, a medical device must meet the following conditions:
Approval by Recognized Authorities: The device must have been approved by at least one authority listed in Annex 1 (e.g., FDA, TGA, Health Canada).
Market History: The device must have been marketed for at least one year without global safety issues, such as:
No reported deaths or serious health deterioration.
No open field safety corrective actions or recalls.
Unchanged Design: The device’s design and intended purpose must remain consistent with its approved version.
No Rejections: The device must not have been rejected or withdrawn by any recognized authority.
Devices that fail to meet these criteria must undergo a full conformity assessment.
A registered Conformity Assessment Body (CAB) evaluates the submitted evidence and verifies compliance with Malaysian regulations.
The verification pathway offers an efficient alternative for medical device registration in Malaysia, leveraging prior approvals from recognized authorities to streamline processes without compromising safety standards. By adhering to this guideline and utilizing MeDC@St effectively, manufacturers can achieve faster market access while ensuring compliance with regulatory requirements.
📌 For detailed guidance, refer to the official MDA documents.
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