• Common questions about the approval processes:
  • SIRIM Type Approval
    • How long does the SIRIM type approval process take?
      • If all your documents are complete and meet the requirements for the issuance of the SIRIM CoC (Certificate of Conformity), the process is normally completed in 5-7 working days.
  • ST CoA
    • What documents are required for ST CoA?
      • Type Test Report (CB/IEC)
      • 2. COC (for Wireless/RF products only)
      • 3. Declaration Identification Letter (if brand and model not the same with the original)
      • 4. Instruction Manual (if requested)
      • 5. Letter of Consent from the Original Brand Owner (if requested)
      • 6. Letter of Consent to Use Other Companies Test Reports (if requested)
      • 7. List of Components
      • 8. Sample for Assessment (if requested)
      • 9. Schematic Diagram
      • 10. Technical Specification and Catalogue
      • 11. Test Certificate
      • 12. Verification / Partial / Assessment Report
  • NPRA Registration
    • What is the timeline for NPRA registration?
      • NPRA registration varies depending on the category of products. If your product is classified as cosmetics, it takes 2 weeks and if it is health supplements, it can take up to 6 months.
    • Is it Possible to Modify a Product’s Label/Formula After it is Registered?
      • Yes, that is still feasible. It is possible to make NPRA Quest 3 online submissions in order to change the specifics of a verified product. Before it can be enforced, all changes/amendments require approval from the NPRA. Online notification of the approval and decision will be presented. The product formulation, however, cannot be altered if there is a change in the active composition. New requests from National Pharmaceutical Regulatory Agency must be made in this case.
      • To avoid any mistakes in formulation statements and active ingredients listing and eliminate the need for amendments, cancellations, and re-payments for a new application, it is advisable to hire a consultancy agency in Malaysia for NPRA applications.
    • What Should Foreign Companies do to Sell Pharmaceutical Products in Malaysia?
      • Before being able to be commercialized in Malaysia, all pharmaceutical products registration should be registered with the Drug Control Authority. To become the owner of the registration certificate, a foreign corporation that wants to introduce pharmaceutical product registration into Malaysia first has to find a local agency (a company registered in Malaysia).
      • For cosmetic product registration, the online registration procedure for all cosmetic products has been substituted by the online notification procedure as of 1 January 2008. Before putting the products on the local market, firms attempting to introduce new cosmetic products should inform the NPRA.