The National Medical Products Administration (NMPA) of China has released a new notification (Notification No. 17 of 2024) detailing significant updates regarding the management and classification of in vitro diagnostic reagents.
Key Updates of China's Updated Classification Guidelines for In Vitro Diagnostic Reagents Include:
1. Existing Registrations: In vitro diagnostic reagents that have been approved and are effective before January 1, 2025, will remain valid within their approved period.
2. New Registrations: From January 1, 2025, new registration applications for in vitro diagnostic reagents must adhere to the new classification catalogue. If applications submitted before this date have not been decided upon, they may continue under the old catalogue. However, if the product category changes under the new catalogue, the registration certificate will note this, and its validity will not extend beyond January 1, 2027.
3. Category Adjustments: For products approved before January 1, 2025, if the management category changes from a higher to a lower risk category, the registrant must apply for continued registration or filing under the new category. Conversely, if the category changes from a lower to a higher risk, a new registration must be applied for under the new category.
4. Renewal and Change Applications: For applications received before January 1, 2025, that have not yet been decided, the NMPA will continue to process these under the old catalogue. Approved changes will be noted on the new registration or filing documents.
5. Class I In Vitro Diagnostic Reagents: From now until June 30, 2024, Class I in vitro diagnostic reagents can be filed under the old catalogue. Starting July 1, 2024, filings must comply with the new catalogue. For filings completed before this date, registrants must review and adjust their filings to conform to the new catalogue.
This update aims to streamline the registration and management processes for in vitro diagnostic reagents, ensuring compliance with evolving regulatory standards and supporting the safe use of these products in medical diagnostics.
MEDTECH NEWS
More Insights into China's Updated Classification Guidelines for In Vitro Diagnostic Reagents
14 05 2024China's NMPA introduced significant updates to the management and classification of in vitro diagnostic reagents. These updates include maintaining the validity of existing registrations approved before this date and requiring new registration applications to comply with a revised classification catalogue. The changes also address category adjustments, where products must re-register under the new or old categories depending on risk level adjustments. Additionally, the NMPA will continue processing renewal and change applications received before the effective date under the old catalogue. Class I in vitro diagnostic reagents have a specific transition period until June 30, 2024, after which they must comply with the new catalogue. These revisions aim to enhance the regulatory framework, ensuring the safety and efficacy of in vitro diagnostic reagents in line with current standards.