MDA Join WHO Collaborative Registration Procedure (CRP) to Accelerate Approval of Prequalified IVDs

On February 3, 2026, Malaysia’s Medical Device Authority (MDA) officially joined the World Health Organization (WHO) Collaborative Registration Procedure (CRP) for in vitro diagnostic medical devices (IVDs). The announcement marks a significant step toward greater regulatory reliance and more efficient market access for eligible WHO-prequalified products.

The new pathway allows the MDA to leverage WHO prequalification assessments rather than repeating extensive technical reviews, helping shorten approval timelines while maintaining Malaysia’s national regulatory requirements.

WHO CRP Pathway Review Timeline

The WHO CRP pathway offers one of the fastest routes currently available for eligible IVD registrations in Malaysia.

The MDA has stated that it aims to issue a regulatory decision within 90 working days. The review clock begins only after:

• A complete application has been submitted through MeDC@St; and
• The MDA has received the relevant confidential reports directly from WHO.

This represents a substantial reduction compared with conventional registration timelines for Class B, C, and D medical devices, which typically range from 180 to 240 working days.

Eligibility Requirements for the WHO CRP Pathway

Manufacturers and applicants must satisfy several conditions before an IVD can qualify for the accelerated pathway.

Product Eligibility

The IVD must:

• Be currently included on the official WHO Prequalification List
• Be identical to the WHO-prequalified version in design, manufacturing process, specifications, and intended use

Any differences between the Malaysian submission and the WHO-prequalified product could prevent eligibility for the CRP pathway and may require a standard registration route.

Applicant Requirements

The application must be submitted by a locally licensed establishment in Malaysia that holds a valid Establishment License, including:

• Manufacturer
• Authorized Representative
• Importer

In addition, the manufacturer must provide formal written consent authorizing WHO to share confidential assessment and inspection reports directly with the MDA.

How the MDA WHO CRP Process Works

The implementation process involves coordinated actions between the manufacturer, WHO, and the MDA.

Step 1: Manufacturer Authorizes Information Sharing

The manufacturer submits a consent form to the WHO Prequalification Team identifying Malaysia’s MDA as the designated recipient of confidential documentation.

Step 2: Local Applicant Submits Registration

The Malaysian license holder submits the registration application through the MeDC@St system and identifies the submission as a WHO CRP Pathway application.

Step 3: WHO Transfers Assessment Reports

Following notification, WHO shares its unredacted Product Assessment Reports and Inspection Reports directly with the MDA through a secure platform.

Step 4: MDA Conducts an Abridged Review

The MDA performs an abridged assessment focused on Malaysian-specific regulatory requirements rather than re-evaluating technical evidence already reviewed through WHO Prequalification.

Final Thoughts

By participating in the WHO CRP, the MDA strengthens its position as a forward-thinking regulator in the ASEAN region while expanding the use of regulatory reliance to accelerate access to quality-assured diagnostics.

For manufacturers, the pathway offers a more efficient and predictable route to market; for the Malaysian public, it supports faster access to diagnostic products that meet internationally recognized standards for safety and performance.

As companies seek to take advantage of this accelerated pathway, ensuring compliance with local regulatory requirements remains critical. Cisema supports manufacturers with Medical Devices and In-Vitro Diagnostics registration strategies, local representation requirements, and regulatory submissions throughout Malaysia and the wider ASEAN region.

Need support navigating Malaysia’s WHO CRP pathway or preparing an MDA registration strategy for your IVD portfolio? Contact Cisema’s regulatory experts to discuss your market access and compliance requirements.

Further Information

Explore Cisema's services for medical device and IVD registration in Malaysia.

Reference

MDA Announcement 1776