1. Overseas inspections
By the end of 2017, the National Bureau (NMPA) has launched on-site flight inspections on 45 overseas medical device manufacturers. The inspection results of 24 of them have been reported on the official website. In 2019, on-site inspections of overseas companies will continue.
2. Notification of results of 3M Health Care overseas site inspection
Two problems were found on the spot inspection:
1)The registered product standard (YZB/USA 5456-2014) of transparent dressing (National Food and Drug Administration (imported) No. 2014 No. 2644698) stipulates that the finished product should be stored in a dry and ventilated room, not exposed to direct sunlight. The storage conditions is not inconsistent with the product instruction recommendation "cooling and drying" are inconsistent.
2)The minimum value of the speed specified in the semi-annual maintenance record (No. 760733) of the line speed gear pump in the rubber coating and film extrusion equipment and is inconsistent with the calibration specified by the third-party verification certificate (No. 730718) of the tachometer used for the measurement (the former is smaller than the latter).
3. Notification of results of Leica Biosystems Newcastle Ltd. overseas site inspection
A total of seven problems were found on the spot inspection:
1)The main raw material of HER-2 test kit, mouse IgG and hydrogen peroxide supplier, has changed, and has not been applied for registration modification according to the requirements of the “Regulations on the Registration of In Vitro Diagnostic Reagents” (General Administration Order No. 5).
2)HER-2 product raw material CB11 mouse clone antibody preparation process is inconsistent with CFDA approved product technical requirements.
3) The serial number of sodium azide in the BOM is ZCS017, and the number of the on-site material label is ZA7022. The company failed to provide supporting documents with different codes for the same material.
4)The number of raw materials hematoxylin and intermediate sections was inconsistent with the SAP system.
5) The company stipulates that the number of samples for each batch of HER-2 products is three, and the sampling amount for each batch of P53 products is one, but the enterprise cannot provide a statistically significant basis for determining the number of samples.
6) The factory inspection items of P53 products do not conform to the technical requirements. Like the dilution concentration of the conformity detection antibody is inconsistent, the blank control and the negative control stain are absent.
7)The lack of total organic carbon and easy oxide detection in the purified water testing.
4. Common problems
- Insufficient knowledge, learning and implementation of China GMP regulations.
- The requirements of China's GMP regulations have not been systematically implemented;
- Hardware facilities such as clean workshops, air conditioners, and purified water do not meet the requirements of China's GMP regulations and guidelines;
- The degree of control of the clean room does not meet the requirements for product cleanliness level;
- The actual production process and testing methods are inconsistent with the methods described in the registration declaration;
- The products were not fully considered in China when they were registered and issued in China, and did not fully consider the requirements of Chinese regulations and PTR (product technical documents);
5. Which foreign companies will be subject to overseas inspection
- The need for registration review
- Import inspection and sampling inspection failed
- Serious recalls and adverse events
- Manufacturers are inspected by other regulatory agencies to show significant defects
- Review after rectification
- Routine compliance check
The rest results of 24 overseas medical device flight inspection reported could be found on the official website.