【Regulatory Alert】The inspection result of 12 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 January 30th, 2019, NMPA continuously announced the onsite inspection results of other 12 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 medical devices manufactured by these enterprises cover many medical device categories, including dialyzers, detection kits (IVD), MRI systems, breathing machines, patient monitors, defibrillators etc. The most inspected devices are dental implants and artificial lens. The most products belong to Class III medical devices. As CIRS mentioned, the new regulations are stringent for overseas enterprises, which is one of the most important steps for NMPA to manage China imported medical device market. All inspected enterprises have more or less problems. The problems covers the following aspects:

-Production record inspection

-Protective measures on productive process

-Maintenance and cleaning of manufacturing equipment

-Manufacturing technique

-Monitoring records

-Production control documents

-Raw material purchase records

-Requirement of inspection procedure and standard

-Document number management

CIRS comments

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.

If you have any demand for the service or want to receive newest regulatory alert, please contact us at md@cirs-group.com

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Mr. Edwin Wen (Beijing office)
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CIRS Europe

Bryan Zhou
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Mr. Junho Lee 
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