MDA Participation in WHO Collaborative Registration Procedure for Prequalified IVDs

The Medical Device Authority (MDA), Ministry of Health Malaysia, has officially joined the World Health Organization Collaborative Registration Procedure (CRP) for WHOprequalified in vitro diagnostics (IVDs) effective 3 February 2026. This reliance based regulatory mechanism is designed to accelerate national registration by leveraging WHO prequalification assessments while ensuring compliance with Malaysia’s regulatory requirements.  

Key Updates on MDA Participation in WHO CRP

Under the WHO CRP, the MDA is now a participating National Regulatory Authority (NRA) that can access confidential assessment reports from WHO’s prequalification programme to facilitate the registration of WHOprequalified IVDs in Malaysia. This collaborative framework reduces duplicative regulatory work, supports efficient decision-making, and enhances access to quality assured diagnostics.  

To participate in the CRP pathway:

• IVD products must be successfully prequalified and listed under WHO’s Prequalification Programme.  

• Submitted products must be identical in essential features to the WHOprequalified version.  

• Manufacturers must provide written consent for WHO to share confidential assessment reports with MDA.  

• Applicants must comply with Malaysia’s regulatory submission requirements and fees in addition to CRP conditions.  

Eligibility and Scope of the CRP Pathway

Manufacturers or authorized representatives seeking accelerated registration of WHOprequalified IVDs in Malaysia must demonstrate:

• The IVD has been prequalified by WHO.  

• The product for submission in Malaysia is the same product prequalified by WHO.  

• Written manufacturer consent is provided to WHO for sharing assessment reports.  

• Full compliance with MDA’s national regulatory framework, including all applicable submission procedures and fees.  

This reliance approach builds on WHO’s prequalification work to support regulatory efficiency and reduced duplication of assessment efforts.  

Implementation Pathway and Review Timeline

Once a complete CRP application is submitted and MDA has received relevant WHO information, the authority aims to complete its regulatory review within 90 working days. ⁠This timeline enhances predictability and supports faster access to quality assured IVDs in the Malaysian market.  

However, actual timelines may vary depending on:

• Completeness of the submission and supporting data  

• Any additional information requested by MDA  

• National administrative processes and requirements  

Participation in the CRP remains voluntary, and MDA retains full authority to make final decisions on product registration status.  

Benefits of the CRP for Manufacturers and Patients

The WHO Collaborative Registration Procedure offers several benefits for manufacturers and public health alike:

• Accelerated registration timelines compared with traditional pathways  

• Reduced duplication of regulatory assessment work between WHO and national authorities  

• Efficient use of regulatory resources by MDA and manufacturers alike  

• Improved availability of qualityassured IVDs for healthcare providers and patients through faster market access  

By leveraging WHO’s prequalification assessments, NRAs like MDA can make regulatory decisions with confidence while maintaining national regulatory sovereignty.  

Important Notes and Compliance Requirements

Applicants using the CRP pathway should be aware of the following:

1. Participation in the CRP is voluntary and initiated at the manufacturer’s request.  

2. National requirements, including regulatory fees and submission formats, remain applicable.  

3. MDA retains the authority to make the final regulatory decision, even when using the CRP pathway.  

4. Post-registration changes to a registered product must be reported both to WHO and MDA as per CRP procedures.  

Conclusion

Malaysia’s participation in the WHO Collaborative Registration Procedure for prequalified IVDs marks a significant step toward harmonizing regulatory processes with global best practices. The CRP pathway enhances regulatory efficiency by reducing duplication and leveraging WHO prequalification assessments, ultimately accelerating access to quality assured diagnostics while ensuring full compliance with Malaysia’s regulatory framework.  

Internal Links  

• Learn more about MDA Malaysia Medical Device Registration

• Related: MDA Malaysia Medical Device Regulations

External Links

• Official announcement by Malaysia’s Medical Device Authority (MDA).

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