12 Nov, 2018
In order to encourage the development of medical devices intended for rare diseases, CNMPA has drafted a guideline whose key principles where founded on the “Opinions on Deepening the Reform of Examination and Approval System Reform and Encouraging Innovation of Pharmaceutical Medical Devices” published by the General Office of the State Council.
Scope and objects: This guideline is applicable only for the registration and amendment application of medical devices (including IVD device/reagent) intended to be used for the treatment and prevention of rare diseases. Medical devices which have been listed in other countries could be approved under certain conditions. Moreover, the enterprise shall also formulate a risk management plan and conduct relevant research as required.
This guideline covers the following points:
1. Before applying for registration, the applicant may first inquire to the concerned department regarding the applicability of the guideline and to confirm the clinical evaluation path to be taken for the medical device in question. The applicant shall also prepare relevant documentation, and the technical review department shall hold a consultation meeting to discuss the issues raised by the applicant.
2. One of the documents included in the submission requirements is “the preclinical research of the product” where the applicant shall adequately discuss the background of the rare disease and the mechanism of action of the device product in question.
3. The device shall be exempted from clinical trial only if there are adequate pre-clinical studies or other relevant evidences establishing a high benefit-to-risk ratio when the device is used to the patient. Otherwise, clinical trial shall be performed.
4. For imported medical devices which have been listed for the prevention and treatment of rare diseases in other countries, overseas clinical trial data may serve as a valid data for as long as it meets which was issued February 2018.