May 9, 2018

In order to support the development of medical devices urgently needed for clinical purposes (hereinafter referred to as "emergency devices"), such as “for life-threatening cases, or diseases that may endanger public health, CMDE has released a draft of the basic principles of medical devices urgently needed in clinical purposes that may be conditionally approved to accelerate medical device listing. CMDE is open for public opinions before May 31, 2018.

This basic principle is applicable to medical devices which was already confirmed via the procedure –“The Confirmation Procedure of the Urgently Needed Medical Device for Treating Serious Life with No Effective Treatment and for Public Health Care.

The applicant may apply for registration of the emergency devices with the conditions while completing the clinical trial of the safety and effectiveness of the products.

The submitted information shall not only meet the requirements of the basic principles, but also the requirements for the registration of medical devices. Registration regulation may be carried out in accordance with the "Priority Approval Procedures for Medical Devices" and "Special Approval Procedures for Innovative Medical Devices (on Trial)".

In addition, pre-market and post-market clinical trials shall be carried out in accordance with the clinical trial plan, same that as established during the process of registration.

This basic principle covers "pre-clinical study", "the requirement of the pre-market clinical trial", "post market conditional requirements", and "post-market surveillance"      

The medical device department of the CNDA is responsible for the technical review of the application for Class III domestic devices and Class II and III imported devices which are urgently needed clinically.



Official press