For NMPA (National Medical Products Administration) certification in China, there are specific geographical authentication requirements that apply to medical devices. Here’s a summary of these requirements:

1. Manufacturer Location: The NMPA requires that the manufacturing site of the medical devices be subject to an on-site inspection. This means that any manufacturer applying for NMPA registration must have its facilities located either in China or be able to provide comprehensive documentation and possibly facilitate inspections if located abroad.

2. Local Agent Requirement: If the manufacturer is based outside of China, they must appoint a local agent or representative in China who is responsible for the registration process, including communication with the NMPA. This local representative is crucial for facilitating the importation and registration processes.

3. Certificate of Good Manufacturing Practice (GMP): Foreign manufacturers must also ensure that their products comply with the Chinese GMP standards. This might include providing evidence of compliance from their home country, which could be checked during the NMPA's review process.

4. Documents and Testing: Manufacturers are usually required to submit documents that may include quality management system certifications, product testing reports, and evidence that their devices comply with Chinese standards. These documents may vary depending on the class of the medical device (Class I, II, or III) and other specific regulatory requirements.

5. Inspection and Auditing: The NMPA may conduct audits or inspections of manufacturing facilities, particularly for Class II and Class III devices. This is to ensure adherence to local regulations and standards.

It’s important for manufacturers to thoroughly prepare and understand these geographical authentication requirements when seeking NMPA certification for their medical devices. If you have specific devices in mind or need more detailed guidance on the process, let me know!

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