The NMPA certification process of the all-in-one medical examination machine is complex and includes multiple steps. Below is an overview of the general NMPA certification process and steps:
Preparation: Determine the product classification and understand the applicable NMPA regulations and technical requirements. Collect product design and manufacturing information, performance and safety assessments, test reports, instruction manuals, etc.
Select an assessment agency:
Choose an NMPA-accredited medical device evaluation body to work with them for technical file reviews and product evaluations.
Preparation of technical documentation:
Prepare a complete technical file, ensuring that all necessary information is included to meet the requirements of the NMPA.
Application for registration: Submit the medical device registration application to the NMPA, including the complete technical documents, registration application form and other necessary documents.
Preliminary Audit: The NMPA conducts a preliminary review to check that the submitted documents are complete. If the documents are incomplete, additional materials may be required.
Review of technical documents:
The NMPA conducts a detailed review of the submitted technical documentation to ensure that it complies with relevant regulations and standards.
On-site audit (if required):
NMPA may arrange on-site audits to verify the information provided in the technical documentation and the manufacturing conditions of the product.
Assessment Body Audit:
The evaluation body conducts technical document review and product evaluation, and provides evaluation reports.
Publicity: The NMPA will publicize the information of registered medical devices on its official ** for public inspection.
Obtain a Certificate of Registration:
If approved, the NMPA will issue a medical device registration certificate to prove that the product meets the regulatory requirements of the Chinese market.
Certificate of Registration Renewal:
Regularly update the registration certificate to ensure that the product continues to meet the requirements.