330,000 medical equipment companies | FDA began flying test!
Pharmaceutical Network November 22 hearing the country 330,000 medical device operators are aware that the State Administration of Drug Control for the annual inspection of aircraft operators has officially kicked off.
On November 21, the State Administration of Drug Control of the People's Republic of China released the "Flight Inspection Bulletin on Wuhan Silas Medical Technology Co., Ltd.".
The circular shows that on October 17, 2017, Wuhan Seles Medical Technology Co., Ltd. accepted the "medical instruments Operating quality management practices "compliance inspection, and in the field inspection was found five defects.
Wuhan Silai Si company is a medical device operators enterprise , But not manufacturing enterprises.The Company operates in Class II and III medical devices and provides Class II and III medical device storage and delivery services (including in vitro diagnostic reagents, refrigerated and freezers) for medical device manufacturing enterprises.
This is still a listed A-share companies in the domestic medical device management business is ranked number one, larger.
Problems discovered by Wuhan Seles in flight inspection include: the returned products are not stored separately as required; individual purchase Receipt of storage receipt did not fill in the acceptance results; check the expired products in the warehouse qualified area; individual products do not match the goods; individual products failed to provide medical ¬ equipment registration certificate or filing voucher.
In response to the above problems, the requirements of the General Administration of Food and Drug Administration, Hubei Province Food and Drug Administration should be responsible for the rectification of enterprises within a time limit, and follow-up inspection, the relevant circumstances should be promptly reported to the General Administration of Medical Device Supervision Division.
Since the beginning of this year, the General Administration of Drug Control has been flying several dozen medical device companies successively. However, all of them were medical devices for manufacturing enterprises GMP Compliance inspection, or due to check on the report of the Wuhan Silex, is the first time this year, the General Administration of Drug Control released the results of the business inspection.
Note that this will not be the only one to be inspected during the year.
At the national medical device supervision and management conference held earlier this year, the State Administration of Press, Administration of the People's Republic of China (EMG) once heard a message that in 2017, the State Administration plans to inspect 50-80 manufacturing enterprises and 20-40 operating enterprises. Among them, Two categories:
1, storage and transportation of business with special requirements;
2, imported product registration proxy people.
Wuhan Seli Si is the first, has opened his head, then, there should be more than 20 companies were direct inspection by the Directorate General of Drug Administration, was notified to check the results.
This is a state-level flight inspection from the General Administration of Press and Publication, which is different from the level flight inspections in provinces and cities that have started in some places.
