The inspection result of 7 Overseas Medical Device Enterprises

On January 18th, 2019, NMPA announced the onsite inspection results of 5 enterprises and the results of other 21 enterprises will be public gradually. On March 5th, 2019, NMPA continuously announced the onsite inspection results of 7 enterprises. There are 26 overseas enterprises so far inspected by NMPA after the publicity of the new ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018)

The general and significant detects are following:

1. Six of the company's eight training programs in 2017 were not implemented and were included in the 2018 training program, but training was still not planned as of the end of August. (SAMO S.p.A, Italy)

2. The mandatory standard ‘YY 0118-2016 joint replacement implant hip prosthesis’ has been in force on January 1, 2018. The Chinese agent did not inform it to the enterprise and the company did not promptly identify the changes in Chinese mandatory standards. (SAMO S.p.A, Italy)

3. The sealing temperature and sealing speed of different product size packages are different (temperature: 180°C, 150°C, 130°C; speed: 7, 6, 7), but the sealing parameters are not recorded in the company's production records, and pre-production sealing parameter setting record for products of different sizes are not provided. (GELITA MEDICAL GmbH, Czech Republic)

4. The third-party environmental monitoring report provided by the enterprise (No. 18Z0993 - Z0262-18) shows that the pressure in the clean room corridor is higher than that in the softening and stretching process, but the raw materials and semi-finished products such as oxidized cellulose entering the clean room are not purified. Washing operation through the hallway into the washing room possibly contaminates the production operation in the adjacent clean room. (GELITA MEDICAL GmbH, Czech Republic)

5. There are insect trapping devices in the storage area of the enterprise. Many insects are found on the spot, and the precautionary measures against insects in the storage area are insufficient. (AL.CHI.MI.A. Srl, Italy)

6. The enterprise has established a medical device adverse event monitoring system in accordance with EU regulations, but has not identified Chinese adverse event monitoring and re-evaluation regulations. (PERMEDICA S.P.A, Italy)

7. In the enterprise raw material procurement list, the raw materials of different risk levels such as PAI (important) and PBI (secondary importance) are not clearly distinguished, which is likely to cause confusion of the degree of supplier control. (DiaSorin S.p.A., Italy)

8. The production environment control program does not specify the water temperature requirement of the process cooling water; only the process cooling water temperature is less than 78F, while the process cooling water equipment maintenance requirements stipulate that the water temperature is less than 75F. (Varian Medical System, Inc., USA)

CIRS comments

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