The National Medical Products Administration (NMPA) has issued a notification regarding the implementation of the "In Vitro Diagnostic Reagent Classification Catalogue," which includes significant updates to the policies for the manufacturing and distribution of medical devices in China.
Manufacturers and Entrusted Manufacturing Enterprises: Entities involved in the production of in vitro diagnostic reagents must apply for medical device manufacturing licenses or amend their scope of manufacturing in their existing licenses according to the management category specified in their product registration certificates. The scope of the manufacturing license should continue to use the classification "Management Category - 6840 In Vitro Diagnostic Reagents."
Class I In Vitro Diagnostic Reagents: Manufacturers of Class I in vitro diagnostic reagents should handle the production registration according to the Class I in vitro diagnostic reagent registration information. The production scope for these fillings will also use the designation "6840 In Vitro Diagnostic Reagents."
Medical Device Distributors: Distributors of in vitro diagnostic reagents must apply for medical device business licenses or handle the registration for the Class II medical device operations as per the management category indicated in their product registration certificates. The business scope for these licenses and registrations will maintain the use of "6840 In Vitro Diagnostic Reagents."
The NMPA has directed provincial drug regulatory authorities to organize training and dissemination of the "Classification Catalogue" within their administrative regions. These authorities are also tasked with supervising and guiding relevant entities in implementing the catalogue, ensuring proper registration, record-keeping, and regulatory compliance of related products.
This move is part of the NMPA's ongoing efforts to streamline regulatory processes and enhance the management of medical devices, particularly in vitro diagnostic reagents, across China.
MEDTECH NEWS
Regulatory Requirements for Medical Device Manufacturing and Distribution Under the New IVD Classification Catalogue
15 05 2024The National Medical Products Administration (NMPA) of China has released new guidelines under the "In Vitro Diagnostic Reagent Classification Catalogue" to update the regulatory framework for the manufacturing and distribution of medical devices. These guidelines necessitate that manufacturers and distributors of in vitro diagnostic reagents adhere to specific licensing and registration processes based on the management categories detailed in their product registration certificates. The NMPA has mandated continued use of the classification "Management Category - 6840 In Vitro Diagnostic Reagents" across various scopes of manufacturing and distribution. Additionally, provincial drug regulatory authorities are instructed to facilitate the training and implementation of these new regulations to ensure compliance and enhance the management of medical devices, particularly focusing on in vitro diagnostic reagents. This initiative is part of the NMPA’s broader efforts to streamline and improve regulatory processes within the medical device sector in China.