On December 28th, 2018, National Medical Products Administration (NMPA) issued and implemented ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018). CIRS immediately reported the regulations and highlighted overseas enterprises must pay attention to the new regulations and stringently manage manufacture process.
Recently, NMPA announced the onsite inspection results of 5 enterprises. The results of other 21 overseas enterprises will be announced later on the official website. NMPA has required the enterprises to implement rectification measures and submit rectification reports on the problems of implementing Good Manufacturing Practices (GMP) regulations for the medical devices in China.
Products: posterior chamber intraocular lens, capsular tension ring
1) The Chinese GMP requirements are not included in the relevant documents such as the quality manual. The product technical documents do not contain the corresponding national and industrial standards in China.
2) The product documentation requires that the CTR in each polishing bottle should not exceed 60, but no data is recorded in the records or the corresponding control measures are not implemented. In the production record, the second extraction time was 74h 32min, which was inconsistent with the 24-72 hours in the production regulations.
3) In order to establish the sample management program, there is no raw material, and the finished product is sampled.
4) The microbiological limit of purified water exceeded the standard and no preventive measures were taken.
5) The cleaning requirements for work shoes in the clean area are not established, and monitoring data such as surface microbial content is also provided.
6) No temperature control and treatment measures in the clean area
7) Purified water test report is not summarized and classified as required
8) Bio-burden data for the inner packaging of the product prior to sterilization is not monitored and provided
Becton, Dickinson and Company
Products: Vacuum blood collection tube
1) The company is organized by the management representative to conduct management review, not the person in charge of the company.
2) The cleanroom test reported that there were particulates exceeding the standard, but no follow-up measures were taken and it is unknown the product was affected or not.
3) The technical differences between the technical requirements of China and the UK have not been considered and no technical changes have been made in a timely manner.
4) The company has not verified the validity of the setting of the production plant and the external static pressure difference.
5) Related files cannot be effectively associated in the system
6) The company controls the positive test, but the positive bacteria inoculation process is not operated under negative pressure conditions.
Rayner Intraocular Lenses Limited
Products: Injection aspheric acrylic intraocular lens system
1) The company does not recognize Chinese regulations, but also makes comparisons of regulatory differences.
2) The grinding workshop found that the two analytical balances were not in the zero return state and the abnormal state was not identified, and the work surface did not meet the requirements.
3) There is a situation in the clean area colony test report that exceeds the specified action limit. After the test exceeds the standard, the company only pays attention to the subsequent clean test and does not take control measures.
4) Design changes have not been made in time without considering the differences in technical requirements between China and the UK
Waldemar Link GmbH & Co.KG
Products: Hip prosthesis - acetabular inner cup, knee prosthesis
1) The ethylene oxide sterilization process control document of the product only specifies the analytical control requirements of the first stage, and the second stage warehouse analysis is not clear, and the procurement control requirements for the outsourcing process are incomplete.
2) The calibration cycle setting of the CNC machining center used for product production is unreasonable. If the overall data is deviated, the product size will be inaccurate.
Products: Circulating epithelial cell sampling needle
1) The aseptic processing of the product does not use the medium simulated filling test method preferred by ISO13408.1 (YY/T0567.1). The company's aseptic processing process is not confirmed.
2) The glass tube for the initial packaging of the product is a non-sealed ordinary package, and the material directly enters the A-class area after being sterilized by damp heat, and no appropriate particle control measures are taken.
3) The company is equipped with a sampling needle rigidity, toughness test instrument and roughness sample, but the calibration cycle of the above inspection instrument is not clear.
Overseas medical device enterprises usually ignore the significance and update of Chinese regulations, but now it is clear that NMPA will continue to do a good job in the overseas inspection of medical devices in accordance with Administrative Regulations of Drug and Medical Device Overseas Inspection, and continue to promote the overseas production of imported medical devices in compliance with Chinese laws and regulations, and further ensure the safety and effectiveness of imported products.
In order to help all overseas medical device enterprise optimize manufacture process and successfully pass the inspection, CIRS provides the relevant customized service, including collection of relevant Chinese standards and regulations, overseas regulatory training, GMP auditing, local mimic inspection etc. CIRS will also close pay attention to the newest information of overseas inspection and publish regulatory alerts on the official website.
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