Prepare Materials: Gather and prepare all necessary documents and information, including product technical specifications, design documents, quality management system documents, clinical trial data (if applicable), manufacturing processes, etc.
Determine the product classification: Determine which category your product falls under the NMPA to understand the applicable regulations and certification procedures. This may involve classifying products to determine the applicable technical specifications and certification criteria.
Choosing a Certification Body: Choosing an NMPA-accredited certification body is a necessary step for NMPA certification. Make sure that the chosen institution is on the NMPA's list of accrediting bodies.
Technical Review and Testing: Submit the technical file, which will be reviewed by the certification body and may carry out an on-site inspection to verify the information in the document. Products may need to undergo conformity testing to ensure that they comply with the relevant technical specifications.
Evaluation of the quality management system: If the product is required to comply with the requirements of the quality management system, the certification body will evaluate the manufacturer's quality management system document to ensure that it meets the requirements of the NMPA.
Review of clinical trial data (if applicable): If the product is involved in a clinical trial, the certification body will review the relevant clinical trial data to evaluate the safety and efficacy of the product.
Audit report and certification: If the product meets the requirements, the certification body will issue an NMPA certification certificate. This certificate will confirm that the product complies with the country's regulations and standards and can be sold in the market.