Accelerate Market Entry in China with Expert China Agent Services

Path to NMPA Success Starts with Freyr!

To enter the Chinese market, medical device manufacturers without a presence in China must appoint a National Medical Products Administration (NMPA) legal agent/China agent. Freyr can act as your China agent, assisting you in ensuring compliance and enabling a smooth market entry.

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China Agent Services Overview

Foreign manufacturers without a physical office in China must appoint a China-authorized company (China agent) to register their devices in the country. The NMPA legal agent is entitled to manage registration and communicate with the NMPA before and after the registration. The certificate issued by the NMPA will appear on the registration certificate. The license, however, is owned by the manufacturer.

Freyr China Agent Competencies:

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    Legal Agent Support.
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    Laison with the Health Agency (NMPA).
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    Preparation of Documentation According to the NMPA Regulations.
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    Local Device Testing.
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    Post-market Surveillance Activity.
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    Translation Support.
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    License Renewal.
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    Regulatory Advisor.
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    End-to-end Registration Support.

Frequently Asked Questions (FAQs)

A China Agent assists the registrant and filer in fulfilling the obligations stipulated by the regulations on the supervision and administration of medical devices and cooperates with random inspections and investigations of imported medical devices.

Yes, a China agent is required for foreign medical device manufacturers to conduct clinical trials in China. Any foreign manufacturer must designate a domestic enterprise legal person as an agent, and this agent is responsible for coordinating and cooperating with the clinical trial processes and Regulatory requirements in China.

In China, the responsibilities of an agent in monitoring adverse events and ensuring medical device safety include:
 

  • Assisting medical device registrants and recorders in carrying out adverse event monitoring for medical devices.
  • Actively collecting and reporting adverse events and suspicious adverse events to the technical institutions for monitoring purposes as per the provisions of the drug supervision and administration department under the State Council.
  • Reporting overseas adverse events and control measures to the state medical devices administration and national monitoring agencies on time after informing and sending a copy to the local provincial drug supervision and administration department.
  • Promptly reporting follow-up disposals and risk-related information to the provincial drug supervision and management department where the enterprise is located, and announcing it to the public.
  • Cooperating with the investigation of adverse events conducted by technical institutions for monitoring adverse events of medical devices, drug supervision and management departments, and competent health departments.
  • Establishing an information transmission mechanism with the designated agent to exchange information on adverse events monitoring and re-evaluation of medical devices promptly.

    These responsibilities are aimed at ensuring that safety is maintained and any potential risks associated with medical devices are managed effectively.

Medical Device Regulatory Consulting – Proven Expertise

20

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Strategic Global Locations
1500

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Global Customers
2100

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In-house Regulatory Experts
850

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In-country Regulatory Affiliates
5

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Global Delivery Hubs

Accelerate Market Entry in China with Expert China Agent Services

  • Independent representation and Regulatory support.
  • Continuous liaison with the Agency for submissions, queries, and feedback.
  • Single point of contact in the country for liaison with the Regulatory agency.