In China, authorized representatives play a crucial role for foreign manufacturers seeking NMPA (National Medical Products Administration) registration of medical devices. Here are the key regulations and guidelines pertaining to authorized representatives:

1. Role and Responsibilities:

   • The authorized representative acts as the legal entity representing the foreign manufacturer in China.
   • They facilitate communication and interactions with the NMPA on behalf of the foreign manufacturer.
   • The representative must ensure compliance with all Chinese regulatory requirements throughout the registration and post-market phases.

2. Appointment Requirements:

   • The authorized representative must be a legally registered entity in China.
   • They must have the capability and resources to fulfill the responsibilities associated with representing medical device manufacturers.
   • The appointment of the authorized representative must be documented and officially recognized by both the foreign manufacturer and the NMPA.

3. Communication and Documentation:

   • The authorized representative communicates all necessary information and documentation between the foreign manufacturer and the NMPA.
   • They ensure that all documents submitted to the NMPA are accurate, complete, and compliant with Chinese regulations.
   • Any changes or updates regarding the medical device registration or its status must be promptly communicated to both parties.

4. Post-Market Surveillance:

   • The authorized representative assists in implementing and maintaining a post-market surveillance system as required by Chinese regulations.
   • They facilitate the reporting of adverse events and product defects to the NMPA in accordance with Chinese regulatory requirements.

5. Liability and Compliance:

   • The authorized representative may be held liable for non-compliance with Chinese regulations related to the medical device.
   • They ensure that the foreign manufacturer's devices meet all safety, efficacy, and quality requirements stipulated by the NMPA.

6. Change Management:

   • Any changes related to the authorized representative (e.g., contact information, legal status) must be promptly notified to the NMPA.
   • Changes in the relationship between the foreign manufacturer and the authorized representative must also be documented and officially recognized.

7. Registration Process Support:

   • During the registration process, the authorized representative assists in preparing and submitting all necessary documentation and applications to the NMPA.
   • They ensure that the foreign manufacturer's application for medical device registration meets all regulatory requirements and standards.

Navigating these regulations requires a thorough understanding of Chinese medical device regulatory frameworks. Foreign manufacturers often engage local regulatory consultants or legal advisors in China to ensure compliance with these guidelines and facilitate smooth interactions with the NMPA throughout the registration process.