In China, the role of an Authorized Representative (AR) for medical devices registered with the National Medical Products Administration (NMPA) is crucial, especially for foreign manufacturers who do not have a physical presence in China. Here's an overview of the role and responsibilities of the Authorized Representative:

Role of the Authorized Representative (AR):

1. Local Presence: The AR serves as the local representative of the foreign manufacturer within China. They must have a physical presence and legal entity registered in China.

2. Communication Bridge: Facilitates communication between the foreign manufacturer and the NMPA. This includes submitting regulatory applications, responding to queries, and handling correspondence related to device registration.

3. Regulatory Compliance: Ensures that the medical devices imported or manufactured by the foreign company comply with Chinese regulations and standards. This includes ongoing compliance monitoring and reporting to the NMPA.

4. Device Registration: Assists in preparing and submitting registration applications to the NMPA on behalf of the foreign manufacturer. This involves compiling technical documentation, test reports, and other required documents.

5. Post-Market Surveillance: Supports the foreign manufacturer in fulfilling post-market surveillance obligations, such as reporting adverse events, recalls, or field safety corrective actions to the NMPA.

6. Local Representation: Acts as the legal representative in case of regulatory inspections or inquiries by Chinese authorities concerning the medical devices.

Responsibilities of the Authorized Representative:

1. Legal Obligations: Assumes legal responsibilities in China on behalf of the foreign manufacturer for ensuring compliance with all applicable laws, regulations, and standards.

2. Documentation Management: Maintains and updates technical documentation, labeling, and instructions for use in accordance with Chinese requirements.

3. Market Authorization Holder (MAH): For imported devices, the AR may be designated as the Market Authorization Holder (MAH) responsible for obtaining the Medical Device Registration Certificate (MDRC) and maintaining it throughout the device's lifecycle.

4. Conflict Resolution: Handles any disputes or issues that may arise concerning regulatory compliance or device safety in China.

5. Representation in Meetings: Represents the foreign manufacturer in meetings, negotiations, or discussions with Chinese regulatory authorities regarding device registration or compliance matters.

Overall, the Authorized Representative plays a critical role in enabling foreign manufacturers to navigate the regulatory landscape in China smoothly and ensures that their medical devices meet all necessary requirements for market entry and ongoing compliance. Choosing a knowledgeable and reputable AR is essential for successful market access and continued operations in China's medical device market.

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