NMPA registration process for medical software

The process of NMPA registration for medical software mainly includes the following stages:

Preparation stage: Firstly, it is necessary to determine whether your product requires NMPA registration. Different types of products may require different registration procedures. Understand the regulations and technical requirements applicable to your product, including product classification, technical standards, etc. ‌

Document preparation: Prepare product technical documents, including product specifications, quality standards, production processes, safety and effectiveness data, etc. These documents need to provide a detailed description of the product's features and performance. If applicable, clinical trial reports also need to be prepared. ‌

Choose a testing agency: Based on the product type and requirements, select a suitable testing agency to conduct necessary testing and evaluation, which may involve aspects such as product safety, effectiveness, and performance. ‌

Application submission: Submit the NMPA registration application online, fill out the relevant forms, and upload the required documents. If applicable, you may need to pay registration fees. ‌

Preliminary review: NMPA will conduct a preliminary review of your application, checking whether the documents are complete and accurate. If problems are identified, additional information or correction of errors may be requested. ‌

On site inspection (if necessary): For certain products, NMPA may conduct on-site inspections to ensure that your production plant and quality management system meet requirements. ‌

Technical Review: NMPA will conduct a detailed review of your technical documents and test reports to ensure that your product complies with relevant technical standards and requirements. ‌

Approval decision: After technical review, NMPA will make an approval decision. If approved, you will receive an NMPA registration certificate. ‌

Registration Certificate Issuance: Once you obtain the registration certificate, you can legally sell and use your product in the Chinese market. ‌

Subsequent supervision: After obtaining the registration certificate for the product, you still need to comply with relevant regulations and regulatory requirements, including obligations such as regular reporting and quality management. ‌

Please note that the NMPA registration process may vary due to product type, technical complexity, and policy changes. ‌