Guidelines for Self Inspection and Verification of Medical Device Registration Comes into Effect

Just now! The National Medical Products Administration has released the “Guidelines for Self Inspection and Verification of Medical Device Registration”, which will come into effect immediately.

Purpose and Basis  

To strengthen the registration management of medical devices (including in vitro diagnostic reagents), standardize the self-inspection work of registration applicants, and ensure the orderly conduct of self-inspection work for medical device registration, this guideline is formulated in accordance with the “Regulations on the Supervision and Administration of Medical Devices”, “Measures for the Administration of Registration and Filing of Medical Devices”, “Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents”, “Measures for the Supervision and Administration of Medical Device Production”, “Good Manufacturing Practice for Medical Devices”, “Guidelines for the Inspection of Quality Management Systems for Medical Device Registration”, and “Provisions on the Administration of Self-Inspection for Medical Device Registration”.

Scope of application  

This guide can serve as a guiding document for drug regulatory authorities to conduct inspections on self-inspection for the registration of Class II and Class III medical devices. It can also be used as a reference for registration applicants to carry out self-inspection work for registration. It is not enforced as a regulation and should be used on the premise of complying with regulatory requirements.