Detailed Explanations of Emergency Approval Procedures for Medical Device

Recently, due to the epidemic situation of the new type of coronary pneumovirus(NCP), the NMPA has approved 4 new types of coronavirus detection products from 4 medical device enterprises in accordance with the emergency approval procedures.

So what is the emergency approval procedures?

The NMPA have issued the notice on issuing emergency approval procedures for medical devices in 2009, in order to effectively prevent, timely control and eliminate the harm of public health emergencies, ensure that the medical equipment required for public health emergencies is completed as soon as possible.

Scope of application:

- This procedure applies to medical device products required for public health emergencies, and have no similar products have been listed in China; or although similar products have been listed, the product supply cannot meet the emergency treatment needs of public health emergencies . Also, the medical device should be approved by the NMPA.

- Applicants who intend to apply for emergency approval of medical devices shall inform the corresponding medical products administration department in advance of the emergency situation of the product and the development of the product. Management departments of medical products administration at all levels shall know the development of relevant medical devices in a timely manner, adopt early intervention when necessary, conduct technical assessment of the products to be declared, and promptly guide production enterprises to carry out relevant declarations.

For medical devices that apply for emergency approval, the applicant should submit review materials and relevant instructions to the NMPA in advance.

The NMPA set up a special expert group to evaluate and review medical devices for emergency approval. Within 3 days, they confirm whether the product undergoes emergency approval, define the product management category, and notify the applicant of the results.

Basic requirements for each party:

Applicants:

For Class I medical devices approved by the NMPA for emergency approval, the production company should notify the local medical products administration of the province, autonomous region, and municipality in accordance with the relevant provisions of the Measures for the Supervision and Administration of Medical Device Production , and the corresponding medical products administration shall sign in time.

For the Class II and Class III medical devices approved by the NMPA for emergency approval, the medical products administration of the province, autonomous region, and municipality where the manufacturing enterprise is located after receiving the application or change application , in accordance with the relevant provisions of the Measures for the Supervision and Administration of Medical Device Production , should make a decision within 5 days as to whether to issue or change the Medical Device Manufacturing Enterprise License.

Testing center:

For medical devices approved by the NMPA for emergency approval (hereinafter referred to as emergency approval medical devices), the relevant medical device testing center shall organize medical device registration testing within 24 hours after receiving the sample, and issue a test report in a timely manner.

Medical Products Administration:

For emergency examination and approval of medical devices, the corresponding medical products administration shall organize the on-site assessment within 2 days after receiving the application for the assessment of the quality management system of the manufacturing enterprise, and issue a quality management system assessment report in time.

For emergency approval of medical devices, after the corresponding medical device registration department accepts, it shall mark the registration application item as "emergency approval", and a special person shall be responsible for the circulation of registration declaration data on the day of acceptance.

After the Class I emergency approval medical device registration application is accepted, the medical products administration shall complete the technical review and administrative review and approval within 5 days.

After the Class II emergency approval medical device registration application is accepted , the medical products administration shall complete the technical review within 5 days; after the technical review is completed, complete the administrative review and approval within 3 days.

After the Class III emergency approval medical device registration application is accepted , the medical products administration shall complete the technical review within 10 days; after the technical review is completed, complete the administrative review and approval within 3 days.