Qualifications of an Authorized Representative in China

Qualifications of an Authorized Representative in China

Choosing the right in-country representative for your medical device registration is like deciding to get married with your life partner. The authorized representative of your choice must possess the necessary qualifications and skills to ride the rough waves with you along the medical device registration process.

So, what do you need to consider when choosing an in-country agent or authorized representative?

Responsibilities of the in-country agent for imported medical devices of foreign manufacturers:

• The in-country agent shall handle the document submission for the product registration or filing on behalf of the foreign manufacturer’s Class I, II, and III medical devices. This includes any changes concerning registration license or filing information, as well as registration renewal and withdrawal.

• Assist foreign medical device manufacturer applicant in establishing a quality management system appropriate to the product and maintain its effective operations

• Assist foreign medical device manufacturer applicant in developing post-market research and risk control plan and ensure its effective implementation

• Assist foreign medical device manufacturer applicant in performing adverse event monitoring and re-evaluation procedure

• Assist foreign medical device manufacturer applicant in establishing and implementing the product traceability and recall system

• Assist foreign medical device manufacturer applicant in other obligations defined by the State Council drug supervision and management department

What qualification or criteria does a China Agent need to have?

• The enterprise shall be registered and have its domicile located in the People’s Republic of China, regardless whether it is an independent company or subsidiary of the manufacturer

• The enterprise shall have a valid medical device operating licence. The role of the in-country representative for Class II and III medical devices in China is a part of the operational activities related to medical devices. However, Class I is an exception.

• The enterprise shall have a third-party quality management organization or in-house quality management employees related to the business scope and the scale of operation. Quality management personnel should have relevant professional qualifications or position.

• A business location that is suitable for the intended scope of business and the scale of operation.

• The enterprise shall have storage conditions that fit its scope of business and scale of operation. If relevant, these facilities should meet requirements for lighting, ventilation, moisture control, rodent and insect control, fire safety, etc.

• A quality management system that matches with the medical device operations. Enterprises that engage in the operation of Class III medical devices should also have a computerized information management system that meets the requirements of the quality management system for the operation of medical devices to ensure the product traceability.

• The enterprise shall have a third-party quality management organization or in-house personnel with appropriate technical training and after-sales service related to the operations of the medical devices.

• The enterprise shall consist of Medical Device Registration Electronic Filing Information System Digital Authentication, also known as Certificate Authentication (CA). The owner and applicant of the CA shall be the enterprise residing in China, which intends to use the online service for registration submission, NMPA communication, or medical device reporting. The CA allows the in-country manufacturer or China Agent to log in and carry out registration activities related to medical devices through NMPA’s eRPS.

Does your current China Agent hold the applicable qualifications and processes to fulfil the necessary responsibilities?

This is such an underrated topic. Making the right choice of China Agent is a quarter-way to success. Similarly, in life, the result depends on whether you have the right partner.

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