Medical device licenses in China are valid for a period of four years, and they must be renewed during the six-month period prior to expiration. In addition, if certain minor or major changes in the license holder¡¯s operations or products occur during the term of the license, the holder may need to apply for an ¡°amendment¡± to the license. Examples of minor changes are name changes or changes to the wording of the address of a manufacturing facility. Major changes include a change of manufacturing facility, a change in the scope of use, or a change in the specifications or engineering of the device.
Until now, stakeholders have had to submit complete application materials to CFDA for both minor and major changes. In some cases, the materials submitted could be related to aspects of the product or manufacturing that were not affected by the change.
The primary benefit of the Notice is that, in most instances, even for major changes, stakeholders will need to submit only the materials primarily related to the change they are making. For example, if the license holder is changing the location of its domestic manufacturing facility, it will need to submit a declaration describing the change in location, reports on inspections of the new facility¡¯s quality control systems, and a self-test report on the products manufactured at the new facility. Foreign enterprises only need to submit a declaration of the change, ¡°appropriate approval documentation,¡± and a self-test report on the products manufactured at the new facility. However, if the license holder does not re-submit the product standards, the testing report, or the package insert, it shall continue to be bound by those submitted with the original application after the change is approved.
The Notice contains similarly modified requirements for other major changes, such as the scope of use of the device, its specifications, and its performance structure and composition. The Notice provides a list of materials that should be submitted and under what circumstances.
Also of great benefit in conserving stakeholder resources is a truncated renewal process. If there are no changes to the products, product standards, and package insert at the time of renewal, then the license holder only need submit a declaration to that effect, as well as a declaration that the device still complies with mandatory standards in China. In these circumstances, the manufacturer shall continue to be bound by the original product standards and testing report after renewal. When applying for renewal, a ¡°quality tracking report¡± accompanying the application must contain an analysis of any suspected adverse events, their causes, and an explanation of their ¡°influence¡± on the safety and effectiveness of the device.
Still, there are circumstances under which a major change requires a license holder to start the registration process anew. The Notice cites two such circumstances: (1) if there is a change in the ¡°basic principles¡± underlying the product; and (2) if there is a ¡°significant¡± change in the scope of use, structure, design, performance, function, and materials of a device that necessitates a reevaluation of its safety and effectiveness. The Notice does not provide further information on what constitutes a basic-principle or significant change.
The Notice became effective on January 1, 2014. Domestic and foreign manufacturers of medical devices in China should follow its requirements when applying for amendments or renewals to their licenses in the future.
