How Will The IVD Reagent Type Examination Be Performed After National Standards And Reference Materials Are Issued Or Updated?

It is required in Article 25 of the Provisions for In-vitro Diagnostic Reagent Registration that the products with national standards and reference materials should be registered for type examination with national standards and reference materials.

It is also required in the Annex 4 of the Announcement of the China Food and Drug Administration on Issuing the Requirements for the Registration of In-vitro Diagnostic Reagents and the Approved Document Format (2014 No. 44) that the type examination report of the product meeting the requirements of the new generation of national standards or reference materials should be provided, if there is any update issued about the standards and reference materials.

Based on the requirements above, when doing the registration or renewing of an IVD reagent, the reagent should meet the requirements of the current national standards and reference materials, if there are any applicable national standards or reference materials released or updated (the applicability of the product to be judged according to the published instructions of the national standards and reference materials). When submitting the application, if the national standards and reference materials have been released or updated before the date of sampling and examination, the product should be proved to meet the requirements of the current national standards and reference materials. For the renewal application, the issued or updated national standards and reference materials should be used for type examination of the product, if they have been

released or updated before the acceptance date of the application. If the product has been approved, the applicant can also revise the compliance requirements for national standards and reference materials in the product technical requirements by applying for change of permission items.