To the food and drug administrations of all provinces, autonomous regions and municipalities directly under the central government,
According to the Notice of NMPA on Carrying out the National Spot Check of Medical Devices in 2019 (GYJXG No. 6 [2019] ), the national inspection plan for spot check of medical devices in 2019 is now issued to you, and the requirements are as follows:
I. Inspection
The 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 to carry out inspection (a project supported by state budget) based on the mandatory standards for medical devices and technical requirements for the registered or filed products (standards for registered products) in accordance with the 2019 National Inspection Protocol for Spot Check of Medical Devices (a local project aided by the central government) (Attachment 1), and National Inspection Plan for Spot Check of Medical Devices in 2019 (Attachment 2).
II. Re-inspection
In case of any objection from an inspected manufacturer (hereinafter referred to as the applicant) to the inspection conclusion, it may submit an application for re-inspection to the corresponding medical device inspection institution within seven working days from the receipt date of the inspection report. In order to ensure the effectiveness of the re-inspection, any applicant may first select an institution from the List of Recommended Re-inspection Institutions for National Medical Device Spot Check in 2019 (Attachment 3). The re-inspection institution shall accept the application for re-inspection and carry out the 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 the re-inspection application.
III. Objection appeal
In case an inspected manufacturer holds any objection to the inspection method and basis for determination and such an objection cannot be verified through re-inspection, the manufacturer may submit an objection appeal in writing to the provincial administration within seven working days from the receipt date of the inspection report.
The provincial administration shall, within two working days after receiving the application, submit the objection appeal to the National Medical Device Sampling Information System, investigate and verify the objection appeal and affirm the verification results within 15 working days, and submit the proposed treatment to the Technical Supervision Center of National Institutes for Food and Drug Control. In case that the provincial administration does not investigate and verify the objection appeal, affirm the verification results and put forward proposed treatments, the relevant materials will be returned. The applicant who fails to submit its objection or provide valid evidences within the time limit shall be deemed to have accepted the inspection results.
Attachment:
1. 2019 National Inspection Plan for Spot Check of Medical Devices (a local project aided by the central government)
2. 2019 National Inspection Plan for Spot Check of Medical Devices (a project supported by state budget)
3. List of Recommended Re-inspection Institutions for National Medical Device Spot Check in 2019
According to the Notice of NMPA on Carrying out the National Spot Check of Medical Devices in 2019 (GYJXG No. 6 [2019] ), the national inspection plan for spot check of medical devices in 2019 is now issued to you, and the requirements are as follows:
I. Inspection
The 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 to carry out inspection (a project supported by state budget) based on the mandatory standards for medical devices and technical requirements for the registered or filed products (standards for registered products) in accordance with the 2019 National Inspection Protocol for Spot Check of Medical Devices (a local project aided by the central government) (Attachment 1), and National Inspection Plan for Spot Check of Medical Devices in 2019 (Attachment 2).
II. Re-inspection
In case of any objection from an inspected manufacturer (hereinafter referred to as the applicant) to the inspection conclusion, it may submit an application for re-inspection to the corresponding medical device inspection institution within seven working days from the receipt date of the inspection report. In order to ensure the effectiveness of the re-inspection, any applicant may first select an institution from the List of Recommended Re-inspection Institutions for National Medical Device Spot Check in 2019 (Attachment 3). The re-inspection institution shall accept the application for re-inspection and carry out the 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 the re-inspection application.
III. Objection appeal
In case an inspected manufacturer holds any objection to the inspection method and basis for determination and such an objection cannot be verified through re-inspection, the manufacturer may submit an objection appeal in writing to the provincial administration within seven working days from the receipt date of the inspection report.
The provincial administration shall, within two working days after receiving the application, submit the objection appeal to the National Medical Device Sampling Information System, investigate and verify the objection appeal and affirm the verification results within 15 working days, and submit the proposed treatment to the Technical Supervision Center of National Institutes for Food and Drug Control. In case that the provincial administration does not investigate and verify the objection appeal, affirm the verification results and put forward proposed treatments, the relevant materials will be returned. The applicant who fails to submit its objection or provide valid evidences within the time limit shall be deemed to have accepted the inspection results.
Attachment:
1. 2019 National Inspection Plan for Spot Check of Medical Devices (a local project aided by the central government)
2. 2019 National Inspection Plan for Spot Check of Medical Devices (a project supported by state budget)
3. List of Recommended Re-inspection Institutions for National Medical Device Spot Check in 2019
Comprehensive Department, NMPA
April 29, 2019
April 29, 2019