Two ministries issued a document: Medical equipment clinical trial agencies will implement the record management

Pharmaceutical Network November 27 hearing the reporter learned from the State Food and Drug Administration on the 24th, the Food and Drug Administration recently jointly with the National Health and Family Planning Commission released the "medical device clinical trial institutions and the record management approach." According to the approach will be In line with the requirements of the quality management standard for clinical trials of medical devices, the medical device clinical trial institutions that carry out the corresponding levels and capabilities of clinical trials of medical devices shall carry out the record management.

Food and Drug Administration officials said the relevant department, according to "on the deepening review and approval system reform encouragement drug medical instruments Innovative opinions "and other relevant provisions of the medical device clinical trial institutions from the original qualification to record management.According to reports, the clinical trial agencies record management, is conducive to the release of clinical resources, to expand the number of clinical trial institutions to better meet Requirements for medical device clinical trials.

Measures proposed that clinical trials of medical devices should have the medical institutions with the qualifications to practice, with two or more A qualification, with a medical device clinical trial management system and standard Operating procedures and other eleven conditions.

According to the measures, SFDA organizes the establishment of a record management information system for clinical trial institutions of medical devices for the record management of clinical trial institutions of medical devices.A clinical trial institution of medical devices shall, according to the requirements of the measures, assess whether the unit has the clinical trial conditions for medical devices And ability to assess and record in the filing system on their own.

For the provision of false material behavior, the method of concealment of the situation or provide false materials for clinical trial institutions filing, or flawed, not suitable for clinical trials of clinical trial agencies, the food and drug supervision and management departments at or above the provincial level in accordance with the "medical Regulations on the Supervision and Administration of Machinery and Equipment. "SFDA abolished the record filing information of its institutions or relevant specialties, notified the State Health Planning Commission, and made public announcements.

It is understood that the measures from January 1, 2018 come into effect.