WHO-prequalified IVDs: the CRP route into Malaysia.

What changed in 2026.

MDA became a participating national regulatory authority in the WHO Collaborative Registration Procedure (CRP) for WHO-prequalified in vitro diagnostics on 3 February 2026. With the manufacturer’s consent, WHO shares its prequalification dossier review, site inspection and performance evaluation reports with MDA, so MDA can verify the product is the same instead of assessing it again. MDA aims to finish its review within 90 working days of receiving everything from WHO. Participation is voluntary, Malaysian requirements and fees still apply, and MDA keeps the final decision.

WHO’s list of countries in the CRP for IVDs, dated 6 July 2026, has 43 entries. Malaysia, Thailand and the Philippines are the ASEAN members on it.

Who can use it

WHO’s procedure (section 4.2) defines the same product as one with the same product name, regulatory version and product codes; the same manufacturing site and quality management system; the same quality, safety and performance data; the same design, with the same components from the same suppliers; and the same labelling, packaging, instructions for use and intended use. Labels and instructions may be translated if the content stays the same.

The five steps in MDA’s flowchart

1. Confirm WHO prequalification. The IVD must be prequalified before the pathway starts. The technical information in the Malaysian dossier must be the same as that submitted to WHO.
2. Give consent to WHO. The manufacturer sends WHO a signed consent form (Appendix 2 of the CRP procedure) authorising WHO to share its assessment reports with MDA for that product. It may go in with the expression of interest and the application; WHO and MDA share copies with each other.
3. Submit an expression of interest (Appendix 3A) to MDA with the national registration application. If the applicant is not the manufacturer, as when a Malaysian authorised representative applies, WHO’s procedure also requires the manufacturer’s authorisation letter confirming the applicant acts for it.
4. Submit the national registration application: the full dossier, in strict accordance with Malaysian requirements. For IVDs that means the CSDT format in MDA’s IVD guidance; see our CSDT page.
5. MDA evaluates the submission and the declared differences. Any difference between the WHO dossier and the Malaysian one, such as local labelling or climatic stability data, must be declared.

Review time

The two figures differ: 90 working days is roughly four months, 90 calendar days about three. We plan on MDA’s figure. Under WHO’s procedure, if an applicant fails to reply within a reasonable time (WHO gives 90 days as an example), MDA may end the CRP for that product and move it to normal registration.

After registration

• Changes go to both regulators. MDA requires post-registration changes to be submitted to WHO and MDA under section 6 of the CRP procedure. WHO asks applicants to submit changes that are subject to national rules within 30 calendar days of WHO accepting them. Translating labelling into the local language with no effect on quality, safety or performance is not reportable.
• Staying the same matters. If the Malaysian product stops matching the prequalified product, through a change made in one place and not the other, WHO removes it from the list of products registered under the procedure. The Malaysian change rules are on our change notification page.
• Withdrawals are shared. WHO tells MDA if a prequalified IVD is withdrawn, suspended or delisted, and MDA tells WHO if it suspends or cancels the Malaysian registration.
• Malaysian post-market duties still apply: problem reporting, recalls and FCAs, and re-registration every 5 years.

What MDA has not said

• Whether the CAB step is waived. Act 737 section 7 requires Class B, C and D devices to pass conformity assessment by a registered CAB. MDA’s announcement keeps all national requirements and does not mention CABs. Ask MDA before you skip it.
• Which MeDC@St option to use and where the expression of interest and consent form are uploaded. The announcement gives an enquiry email but no system guide.
• How many products have used it. MDA has published no figures.

CRP or verification?

Many WHO-prequalified tests also hold an EU certificate. If it is under an annex MDA/GD/0070 accepts, verification has the shorter published MDA review. The CRP is the better fit when WHO prequalification is the product’s strongest approval. Malaysian IVD classes and dossier rules are on our IVD registration page.