To the food and drug administrations of all provinces, autonomous regions, and municipalities directly under the central government:
According to the Notice of the Office of the State Drug Administration on Carrying out the National Spot Check of Medical Devices in 2018 (YJB [2018] No. 2), we hereby issue the 2018 national spot check protocol for medical devices. Please implement the protocol based on the following requirements:
I、Inspection requirements
Food and drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as the administrations) shall organize relevant inspection institutions according to the mandatory standards and register or file product technical requirements (registered product standards) by following the 2018 Inspection Protocol for Spot Check of National Medical Devices (Subsidy Items from the Central Government to the Local), and 2018 Inspection Protocol for Spot Check of National Medical Devices (State-level Budget Items).
II、Re-inspection requirements
In case of objections from the inspected manufacturers (hereinafter referred to as the applicants) to the inspection conclusion, they may submit an application for re-inspection to the corresponding medical device inspection institution within 7 working days from the date of receipt of the inspection report. In order to ensure the effectiveness of the re-inspection, the applicant may first select a re-inspection institution from the list of recommended institutions for 2018 national medical device spot check. The re-inspection institution shall accept the application for re-inspection and carry out inspection in a timely manner. Applicants who fail to apply for re-inspection within the time limit shall be deemed to have accepted the inspection results and the inspection institution shall no longer accept re-inspection application.
III、Requirements of objection complaints
In case the inspected manufacturers hold objections (hereinafter referred to as the applicant) to the inspection method and basis for determination and such objections cannot be verified through re-inspection, they may submit an objection complaints in writing to the local administration within 7 working days from the date of receipt of the inspection report. 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 China Drug Administration. Applicants who fail to raise objections or provide valid evidences within the time limit shall be deemed to have accepted the inspection results.
According to the Notice of the Office of the State Drug Administration on Carrying out the National Spot Check of Medical Devices in 2018 (YJB [2018] No. 2), we hereby issue the 2018 national spot check protocol for medical devices. Please implement the protocol based on the following requirements:
I、Inspection requirements
Food and drug administrations of all provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as the administrations) shall organize relevant inspection institutions according to the mandatory standards and register or file product technical requirements (registered product standards) by following the 2018 Inspection Protocol for Spot Check of National Medical Devices (Subsidy Items from the Central Government to the Local), and 2018 Inspection Protocol for Spot Check of National Medical Devices (State-level Budget Items).
II、Re-inspection requirements
In case of objections from the inspected manufacturers (hereinafter referred to as the applicants) to the inspection conclusion, they may submit an application for re-inspection to the corresponding medical device inspection institution within 7 working days from the date of receipt of the inspection report. In order to ensure the effectiveness of the re-inspection, the applicant may first select a re-inspection institution from the list of recommended institutions for 2018 national medical device spot check. The re-inspection institution shall accept the application for re-inspection and carry out inspection in a timely manner. Applicants who fail to apply for re-inspection within the time limit shall be deemed to have accepted the inspection results and the inspection institution shall no longer accept re-inspection application.
III、Requirements of objection complaints
In case the inspected manufacturers hold objections (hereinafter referred to as the applicant) to the inspection method and basis for determination and such objections cannot be verified through re-inspection, they may submit an objection complaints in writing to the local administration within 7 working days from the date of receipt of the inspection report. 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 China Drug Administration. Applicants who fail to raise objections or provide valid evidences within the time limit shall be deemed to have accepted the inspection results.
Office of State Drug Administration
May 25, 2018
May 25, 2018