Authorized representatives play a crucial role in the registration and regulatory compliance of medical devices in China, particularly for foreign manufacturers. Here’s an overview of their responsibilities and the regulatory requirements they must meet under NMPA (National Medical Products Administration) regulations.

Responsibilities of Authorized Representatives

1. Registration and Submission:

   • Facilitate the registration of medical devices with the NMPA on behalf of the foreign manufacturer.
   • Prepare and submit all necessary documentation, including technical files, clinical data, and quality management system (QMS) information.

2. Regulatory Compliance:

   • Ensure that the manufacturer’s products comply with Chinese regulations, including relevant standards (GB standards).
   • Monitor changes in regulations and inform the manufacturer about new compliance requirements.

3. Communication with NMPA:

   • Act as the primary contact point between the NMPA and the manufacturer, managing all communications, queries, and submissions.

4. Post-Market Surveillance:

   • Oversee post-market surveillance activities, ensuring that any adverse events or product complaints are reported to the NMPA in a timely manner.
   • Collect and analyze feedback from the market to maintain device safety and effectiveness.

5. Quality Management Support:

   • Assist in maintaining the manufacturer's QMS to ensure ongoing compliance with regulatory requirements.
   • Facilitate audits and inspections by regulatory authorities.

6. Labeling and Marketing:

   • Ensure that all labeling and marketing materials comply with Chinese regulations and are appropriately translated into Chinese.
   • Validate that the product is marketed according to its registered specifications.

Regulatory Requirements for Authorized Representatives

1. Legal Entity:

   • The authorized representative must be a legally registered entity in China, such as a domestic company or organization, that has the capability to perform the required responsibilities.

2. Designation and Documentation:

   • The foreign manufacturer must formally designate the authorized representative through a written agreement.
   • This agreement should outline the scope of responsibilities and obligations of the representative.

3. Registration with NMPA:

   • The authorized representative must be registered with the NMPA as part of the medical device registration process.
   • They must submit their business license and relevant qualifications to the NMPA during the registration process.

4. Compliance with Good Manufacturing Practices (GMP):

   • The authorized representative should ensure that the manufacturer complies with Good Manufacturing Practices (GMP) as required by NMPA regulations.

5. Training and Expertise:

   • The representative should have adequate knowledge of Chinese regulations, medical device standards, and the specific product category they are representing.
   • Continuous training may be required to stay updated on regulatory changes.

6. Reporting Obligations:

   • Authorized representatives must ensure timely reporting of any adverse events, product recalls, or changes in product status to the NMPA.
   • They should maintain records of all communications and submissions to the NMPA.

Conclusion

Authorized representatives are essential for foreign manufacturers seeking to navigate the complexities of medical device registration and compliance in China. By understanding their responsibilities and adhering to regulatory requirements, they can effectively support the manufacturer in achieving and maintaining compliance with NMPA regulations. This partnership not only facilitates smoother market entry but also ensures that medical devices meet the safety and efficacy standards required in China.

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