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| Sichuan province, check medical equipment! No, no! |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-16 11:04:32 Number Browse：669 |
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The food and drug administration of sichuan province ordered the operation and operation of medical devices in the whole province. Uncertified, it's going to be terrible!
In sichuan in the notice said that the object is within the scope of the province of the special inspection of the medical equipment production, management and use of units, mainly the production of sterile implantable high-risk medical devices, using operation link of lenses, condoms, contact lenses, beauty with sodium hyaluronate, large medical equipment and consumables for review.
There are three main points in the review:
In the production process, we should strictly check the behavior of the second and third types of medical devices. Focus on the production of sterile implanted medical devices.
In business processes, to hunt down without permission or registration engaged in the management of medical equipment business, has not obtained a medical device registration certificate or registration certificate of medical devices and refurbished medical equipment import sales illegal behavior. Focus on the hotel, the small commodity trading market.
In the use of the link, we should strictly inspect the purchase and acceptance, and check the use of unlicensed products, especially the use of large equipment and consumables. Focus on large medical institutions and beauty salons.
It is understood that this inspection is conducted in three stages. Among them, the middle of August - in the middle of September is the "stage" of the organizations, municipal bureau of state require companies to fully carry out self audits, and introspects the results and their rectification report submitted to the jurisdiction, state food medicine department.
In late September - at the end of October is centralized inspection phase, secri food medicine department in accordance with the established inspection scheme of related production and business operation and use of medical equipment units to carry out the centralized checking, found in the inspection unlicensed production and management of medical equipment and the production and business operation and use of unlicensed medical devices unit, strictly in accordance with the law, investigate, major inform ShengJu case.
The provincial bureau will organize inspection teams according to work arrangement to conduct spot checks on the special inspection work of various cities (state) bureaus.
November is the summary stage. |
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