To the drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government, the drug administrations of Xinjiang Production and Construction Corps, National Institutes for Food and Drug Control, and relevant inspection agencies,
According to the Notice of the Comprehensive Division of the National Medical Products Administration on Carrying out the National Medical Device Quality Sampling Inspection in 2021 (YJZXG [2021] No.18), the Inspection Plan for National Medical Device Sampling Products in 2021 is hereby issued to you, and the relevant requirements are notified as follows:
I. Inspection
The drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government, and the drug administrations of Xinjiang Production and Construction Corps (hereinafter referred to as the administrations), National Institutes for Food and Drug Control shall organize relevant inspection institutions to carry out inspection according to the mandatory standards for medical devices and the technical requirements of registered or filed products (registered product standards) in accordance with the National Inspection Plan for Sampling Varieties of Medical Devices in 2021 (Annex 1).
II. Re-inspection
In accordance with Article 32 of the Administrative Measures for Quality Sampling Inspection of Medical Devices, in case that the inspected manufacturers or the medical device registrants, filers and agents of imported products hold objections to the inspection conclusion, they may submit an application for re-inspection to the re-inspection institution (Annex 2) recommended by this plan within 7 working days from the date of receipt of the inspection report. The re-inspection institution shall accept the application for re-inspection and carry out inspection in a timely manner. If an application for re-inspection is filed beyond the time limit, the inspection institution will no longer accept it.
III. Objection Complaints
In case the inspected manufacturers or the medical device registrants, filers and agents of imported products hold objections to the inspection method and basis for determination and such objections cannot be verified through re-inspection, they shall submit an objection complaints in writing to the local administration within 10 working days from the date of receipt of the inspection report, together with relevant supporting materials.
The local administration shall, within 2 working days after receiving the application, submit the objection complaints to the National Medical Device Sampling Information System, investigate and confirm the objection complaints within 15 working days, and submit the treatment proposal to the Technical Supervision Center of National Institutes for Food and Drug Control. If the relevant administrations fail to conduct investigation and audit, and fail to put forward verification results and treatment proposal, the relevant materials will not be handled.
IV. Other Requirements
After receiving the test results of risk monitoring products, medical device registrants and filers shall actively assess and eliminate risks according to the risk monitoring prompts, and the local administrations shall supervise and guide enterprises to control risks. The test results of risk monitoring products shall not be used as the basis for administrative punishment and announcement.
Annex:
1. National Inspection Plan for Sampling Varieties of Medical Devices in 2021
2. List of Recommended National Medical Device Sampling and Re-inspection Institutions in 2021
According to the Notice of the Comprehensive Division of the National Medical Products Administration on Carrying out the National Medical Device Quality Sampling Inspection in 2021 (YJZXG [2021] No.18), the Inspection Plan for National Medical Device Sampling Products in 2021 is hereby issued to you, and the relevant requirements are notified as follows:
I. Inspection
The drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government, and the drug administrations of Xinjiang Production and Construction Corps (hereinafter referred to as the administrations), National Institutes for Food and Drug Control shall organize relevant inspection institutions to carry out inspection according to the mandatory standards for medical devices and the technical requirements of registered or filed products (registered product standards) in accordance with the National Inspection Plan for Sampling Varieties of Medical Devices in 2021 (Annex 1).
II. Re-inspection
In accordance with Article 32 of the Administrative Measures for Quality Sampling Inspection of Medical Devices, in case that the inspected manufacturers or the medical device registrants, filers and agents of imported products hold objections to the inspection conclusion, they may submit an application for re-inspection to the re-inspection institution (Annex 2) recommended by this plan within 7 working days from the date of receipt of the inspection report. The re-inspection institution shall accept the application for re-inspection and carry out inspection in a timely manner. If an application for re-inspection is filed beyond the time limit, the inspection institution will no longer accept it.
III. Objection Complaints
In case the inspected manufacturers or the medical device registrants, filers and agents of imported products hold objections to the inspection method and basis for determination and such objections cannot be verified through re-inspection, they shall submit an objection complaints in writing to the local administration within 10 working days from the date of receipt of the inspection report, together with relevant supporting materials.
The local administration shall, within 2 working days after receiving the application, submit the objection complaints to the National Medical Device Sampling Information System, investigate and confirm the objection complaints within 15 working days, and submit the treatment proposal to the Technical Supervision Center of National Institutes for Food and Drug Control. If the relevant administrations fail to conduct investigation and audit, and fail to put forward verification results and treatment proposal, the relevant materials will not be handled.
IV. Other Requirements
After receiving the test results of risk monitoring products, medical device registrants and filers shall actively assess and eliminate risks according to the risk monitoring prompts, and the local administrations shall supervise and guide enterprises to control risks. The test results of risk monitoring products shall not be used as the basis for administrative punishment and announcement.
Annex:
1. National Inspection Plan for Sampling Varieties of Medical Devices in 2021
2. List of Recommended National Medical Device Sampling and Re-inspection Institutions in 2021
Comprehensive Division of National Medical Products Administration
April 9, 2021
April 9, 2021