Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China

On September 18, 2020, the National Medical Products Administration issued the Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China No.104 of 2020.

The purpose was to further implement the State Council's Opinions on Reforming the Review and Approval System for Pharmaceutical and Medical Devices and Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices.

As well as to implement the reform of "streamlined administration and delegated power, improve regulations, and upgrade services" and the requirements for optimizing the business environment, comprehensively deepening the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs.

This article explains the announcement which covers the production of products with an imported medical device registration certificate in China:

I. Scope of application

This announcement applies to matters relating to the production of Class II and Class III products with a registration certificate for imported medical devices by a registrant of imported medical devices through its foreign-invested enterprise established in China.

II. Registration Requirements

1. The foreign-funded enterprise established within the territory of China by the registrant of the imported medical device shall, as the registration applicant, submit the application for domestic medical device registration to the corresponding Medical Products Administration.

Except for the name, the residence of the registrant, and production address, the contents of the registration application in principle ought to be consistent with the relevant matters specified in the corresponding registration certificate of the imported medical device and its attachments.

2. The registration applicant must submit the registration application data in accordance with the requirements of the following regulations:

• Announcement on the Requirements for Registration Application Data and the Format of Approval Certification Documents for Medical Device (NMPA Announcement No.43 of 2014)

• Announcement on the Requirements for Registration Application Data and the Format of Approval Certification Documents for In Vitro Diagnostic Reagents (NMPA Announcement No.44 of 2014)

Among them, the following data could be submitted adopting the original registration application data of imported medical devices/IVD Reagents:

Medical Devices:

• Review data;

• Research data;

• Clinical evaluation data; and

• Products risk analysis data.

IVD Reagents:

• Review data;

• Research data of main raw materials (if applicable);

• Research data of main production processes and reaction systems (if applicable);

• Analytical performance evaluation data;

• Data for determining Cut-off or reference interval;

• Stability research data;

• Clinical evaluation data; and

• Products risk analysis data.

3. The registration and declaration procedures shall be carried out in accordance with the Measures for the Registration and Administration of Medical Devices, the Measures for the Registration and Administration of In Vitro Diagnostic Reagents, and the relevant regulations on the electronic declaration of medical devices.

4. If the registration application is submitted and approved in accordance with the requirements of this Announcement, the registration number of the medical device registration certificate of the imported product that has been approved shall be indicated in the remarks column of the registration certificate.

Ⅲ Registration System Verification Requirements

The registration applicant shall ensure that the domestic production includes the main production process of the product, promise that the main raw materials and production process will not change, and provide the self-inspection report that the quality management system of the product produced in China conforms to the Medical Device Production Quality Management Standards and the equivalence comparison report of domestic and overseas quality management systems.

In accordance with the verification procedures of the medical device registration quality management system, the medical products administrations carry out a comprehensive verification of domestic registration applicants, focusing on the equality and traceability of domestic and foreign quality management systems, as well as whether changes in the system brought about by changes in the production process will create new risks and lead to changes in registration matters.

IV. Post-marketing regulatory requirements

Domestic registrants shall apply for the medical device production license in accordance with the Measures for the Supervision and Administration of Medical Device Production, strictly implement the main responsibility of quality and safety, and strengthen the quality management of the whole life cycle of medical devices, establish and improve the quality management system and ensure its effective operation in accordance with the requirements of the Good Manufacturing Practice for Medical Devices.

V. Others

Where an overseas registrant invested by a Chinese domestic enterprise produces the Class II, and Class III products that have obtained the registration certificate for imported medical devices in China, the implementation shall be carried out in accordance with this Announcement, and the Chinese domestic enterprise that invested in the overseas registrant shall be the registration applicant to apply for the registration of the products

The products in Hong Kong, Macao, and Taiwan that have obtained medical device registration certificates are subject to this announcement. This announcement shall take effect as of the date of the announcement.

National Medical Products Administration

September 18, 2020