The Medical Device Authority (MDA), Ministry of Health Malaysia, has officially joined the WHO Collaborative Registration Procedure (CRP) as a participating National Regulatory Authority (NRA) for WHO-prequalified in vitro diagnostic (IVD) products, effective 3 February 2026.
This reliance-based mechanism allows MDA to leverage WHO prequalification assessments to accelerate the national registration process, reduce duplication of regulatory efforts, and improve timely access to quality-assured diagnostics in Malaysia.
Read the full announcement here:
https://portal.mda.gov.my/index.php/announcement/1776-medical-device-authority-mda-participates-in-who-collaborative-registration-procedure-crp-for-prequalified-in-vitro-diagnostics
Purpose of the Announcement
To formally announce MDA’s participation in the WHO Collaborative Registration Procedure (CRP) for WHO-prequalified in vitro diagnostic (IVD) products.
To facilitate reliance on WHO prequalification assessments to streamline the national registration process in Malaysia.
Scope of Application
This announcement applies to manufacturers and applicants of WHO-prequalified in vitro diagnostic (IVD) products seeking registration in Malaysia.
Applications are limited to local manufacturers or Authorized Representatives (AR).
Key Highlights
- Applicable to WHO-prequalified IVD products only
- Participation in CRP is voluntary
- Requires manufacturer consent for WHO to share assessment reports with MDA
- Product must be identical to the WHO-prequalified version (product sameness)
- Applicants must comply with all Malaysian regulatory requirements, including submission procedures and fees
- Target review timeline: approximately 90 working days (subject to completeness and queries)
- MDA retains full authority for final registration decision
- Post-registration changes must be submitted to both WHO and MDA under CRP requirements
Implications to Clients
Manufacturers of WHO-prequalified IVD products may benefit from an accelerated registration pathway in Malaysia through participation in the CRP.
Applicants should ensure product sameness with the WHO-prequalified version and secure the necessary consent for WHO to share assessment reports with MDA.
Despite reliance on WHO assessments, applicants must continue to comply with all Malaysian regulatory requirements, including local submission procedures, documentation, and applicable fees.
Effective Date
3 February 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.