Malaysia Updates Verification Pathway Guidance for Medical Device Registration in Medc@St

The Medical Device Authority (MDA) has released an updated guidance document titled “Establishment Guide to Medical Device Registration Submission in Medc@St Through Conformity Assessment by Way of Verification Process.”

The guidance provides instructions for manufacturers and authorised representatives seeking to register medical devices in Malaysia through the verification pathway, a regulatory route that allows devices already approved by recognised authorities to undergo an accelerated conformity assessment process.

The update introduces several important regulatory changes affecting eligibility criteria, recognised regulatory authorities, and documentation requirements.

Singapore and Thailand Added as Recognised Regulatory Authorities

One of the most notable updates is the inclusion of Health Sciences Authority (HSA) and the Thai Food and Drug Administration (Thai FDA) as recognised regulatory authorities.

With this addition, medical devices approved in Singapore or Thailand may now qualify for Malaysia’s verification pathway, potentially simplifying the registration process for manufacturers operating across the ASEAN region.

Check this: Malaysia Medical Device Registration

Clarification on Approval Schemes Not Eligible for Verification

The guidance also clarifies that certain regulatory approval schemes do not qualify for the verification pathway. These include programs such as:

This applies to approvals from major regulators including the U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Health Canada, Pharmaceuticals and Medical Devices Agency, and the Therapeutic Goods Administration.

The clarification ensures that only fully approved and commercially authorised devices are eligible for the streamlined verification process.

Updated Eligibility Criteria for Verification Pathway

The MDA has also refined the eligibility criteria for the verification pathway.

Previously, devices were required to be marketed for at least one year in the reference country. This requirement has now been removed.

Instead, manufacturers must demonstrate that within the past year:

These changes shift the focus toward device safety performance rather than market duration.

Recognition of MDSAP Certificates for Quality Management Systems

The guidance now explicitly recognises certificates issued under the Medical Device Single Audit Program (MDSAP) for Quality Management System verification.

This recognition aligns Malaysia with international regulatory practices and may reduce the need for additional QMS assessments for manufacturers already participating in the MDSAP program.

Updated Post-Market Surveillance Reporting Period

Another update relates to post-market surveillance requirements.

The previous reference to “3–5 years” of post-market data has been revised. The guidance now standardises the requirement to three years of post-market surveillance information.

Clarified Regulatory Timelines

The guidance also outlines clearer review timelines for both conformity assessment bodies (CABs) and the MDA:

These timelines provide greater transparency for manufacturers planning their regulatory submissions in Malaysia.

What This Means for Manufacturers

The updated guidance reflects Malaysia’s continued effort to streamline medical device registration while maintaining regulatory oversight and patient safety.

Manufacturers planning to register devices in Malaysia through the verification pathway should review the updated eligibility criteria and documentation requirements before submitting applications through the Medc@St system.