Since the "Medical Devices Supervision and Regulation" issued, especially after the "Medical Device Distribution Enterprise License management methods" and relevant implementation rules carring out, the food and drug regulatory authorities to effectively monitor, medical equipment enterprises standardized gradually, legal track. But found in the daily supervision, management, medical equipment business license, there are still many problems need to be addressed.
Operation Mode and scope
Currently, the medical device operation mode in the wholesale and retail are two, there is only a retail business license "above the retail business range " or "retail" character, is not reflected in the permit as a "wholesale" business.
There are two "Medical Equipment Distribution Enterprise License Management Measures" for medical equipment companies to expand business scope without the liability provisions: Article 35 provides that "unauthorized medical device enterprises to expand business scope, reducing operating conditions, the (food ) drug regulatory department shall order rectification, be criticized, and impose more than 10,000 yuan to 20,000 yuan fine "; Article 38, medical equipment enterprises" Beyond the "Medical Equipment Distribution Enterprise License" out of scope of business to carry out business activities ", (food) drug administration should be" ordered to make corrections and give a warning; overdue refuse to correct. Seen that the management approach is the expansion of (beyond) the scope of behavior management to provide financial penalty, the goods involved (medical devices) were not rules, the author considers it necessary to amend targeted.
Strict quality control
Current laws and regulations when buying and selling of medical products obtain records without qualification requirements and acceptance terms, should require drug manufacturers' equipment must be purchased from the manufacturer with medical equipment business enterprise license permits, business licenses corporate procurement, and to obtain the official seal stamped supply a copy of the qualification certificate, the the procurement of medical equipment suppliers establishment and product files. "
Medical equipment purchased should meet the following basic conditions: the legal production and operation of medical equipment; the Medical Device Registration Certificate; a product certification; with product quality standards; brochures, labels, packaging and labeling shall comply with the relevant provisions; medical equipment purchasment must contain legal bills, as required to establish a true and complete record of medical equipment purchasment, so that ticket, account, consistent with its goods. Purchase records required to save.
In addition, the implementation of the above issues should be developed without a penalty clause, to urge the enterprises to do this work, strict quality medical devices.
The current medical device regulations did not provide a license management companies should have a legal product wholesale to qualified businesses. As the relevant laws and regulations is not sound, coupled with the regulatory power is inadequate, the field of medical equipment distribution business without a license, super scope, do not bill the sale of firearms and other phenomena also more common. Therefore, medical devices should be required to operate a legitimate medical device companies will have a legitimate product sales to qualified companies in order to prevent the circulation of counterfeit medical devices.

本文由广州佳誉医疗器械有限公司编辑