In China, the National Medical Products Administration (NMPA) is the competent authority responsible for the registration and certification of medical devices. The following are the general process and steps of NMPA certification for medical devices, which are for informational purposes only and do not encourage any illegal behavior:
Determine the product classification: Determine which class of medical devices your device falls into, as different classes of medical devices may have different certification standards.
Preparation of materials: Prepare complete certification application documents, including product specifications, performance test reports, production processes, quality control systems and other related materials.
Choosing a Certification Body: Choose a qualified certification body for certification. Ensure that the certification body is accredited by the NMPA and is able to provide appropriate services.
Application for Registration Certificate: Submit an application for registration to the NMPA, including detailed product information and related materials. It may be necessary to provide documents such as GMP certificates from manufacturing companies.
Technical evaluation: The certification body may conduct a technical evaluation, including an inspection of the product's performance, quality control, etc.
On-site audits: Certification bodies may conduct on-site audits to ensure that manufacturing processes and quality management meet standards.
Get certified: If the product meets the requirements, the NMPA will issue a certificate of registration that allows the product to be sold and used in the market.