What changes will the newly revised Regulations on Supervision and Administration of Medical Devices bring to the supervision of the class I medical devices?

Although the safety risk of class I medical devices is low, some record listing products do not meet the requirements of laws and regulations or technical standards due to the weak sense of responsibility of some enterprises and non-standard production quality management. In addition, high class products are listed in the form of filing, and non-medical device products are listed as class I medical device.

The newly revised Regulations on supervision and Administration of Medical Devices (hereinafter referred to as the new Regulations) have been implemented since June 1 this year. What impact will the new regulations have on the regulation of class I medical devices? What are the new regulatory issues facing the regulation of class I medical devices?

New changes of the new Regulations in the supervision system of class I medical devices are mainly reflected in the following four aspects:

First, the implementation of the record-holder system. The new Regulations clearly stipulate the implementation of the record-holder system for class I medical devices, which solves the problems caused by the non-inclusion of class I medical devices in the pilot work of the medical device registrant system.

Second, the implementation of informative filing system. The new Regulations make it clear that the listing and production filing of class I medical devices is an “informative” filing, rather than an “examination” filing. That is, whether it is product listing record or production record, the record is completed when the enterprise submits the record data to the drug regulatory authorities  according to the requirements of the record data, and the regulatory authorities no longer needs to review the record data before approving the record, which solves the problem of unclear record behavior regulations. At the same time, in view of the record is the initiative of the enterprise, the enterprise should bear the main responsibility.

Third, the entrustment system is clearly defined. The new regulations clearly stipulate that class I medical devices can be manufactured by record-holder or on commission. In the case of entrusting the production of medical devices, the record-holder of medical devices shall be responsible for the quality of the entrusted production of medical devices, strengthen the management of the production activities of the entrusted manufacturer, and ensure its production in accordance with legal requirements.

Fourth, a new filing cancellation system has been added. The new Regulations clearly stipulate that the record-holder of medical devices shall carry out the reevaluation of the class I medical devices after the listing. If the reevaluation result of the listed medical device shows that the safety and effectiveness cannot be guaranteed, the record-holder of medical device shall take the initiative to apply for cancellation of the filing. Where the record-holder fails to apply for cancellation of record-keeping, the regulatory authorities shall cancel the record-keeping.

Positive effects of the new regulations

The regulatory system for class I medical devices in the new Regulations, especially the record-holder system, will help research and development institutions and medical institutions hold products as the record subject and promote the technical improvement of new products. Under the commissioned production system, it is beneficial to promote the standardization and scale of the class I medical device production.

The new Regulations strengthen the requirements for supervision during and after the event. According to the new laws and regulations, after enterprises submit the record data of class I medical device products, the first thing the regulatory authorities should do is to generate public record information for the record data submitted by the enterprises in accordance with the procedures.

In addition, due to the notification type of filing, whether the filing materials meet the requirements, whether the filing products belong to the class I medical devices, and whether the production filing conditions meet the requirements are included in the post-supervision.

IMD can provide manufacturers with all kinds of  regulation consultation and regulation training services. Please do not hesitate to contact us at info@inspirativemed.com, if you have any question in the gap between your products and NMPA’s standards.