Since the "Supervision and Regulation of Medical Devices" issued, especially since the "Medical Device Distribution Enterprise License management approach" and after the formal implementation of the relevant implementation rules, the food and drug regulatory authorities to effectively monitor, medical equipment enterprises are gradually standardized , legal track. But three days of non-freezing cold day,China fever thermometer manufacturer the medical equipment business license management, there are still many problems, such as in the mode of operation, equipment quality, etc. there are still many problems need to be addressed.
Mode of operation and scope
Currently,China baby thermometer manufacturer pharmaceutical, food and other commodities on a business license and business license will be marked "mode of operation" (wholesale or retail),China wrist blood pressure monitor and medical equipment business license does not have "management approach" one.
Currently, China forehead thermometer the medical device mode of operation in the wholesale and retail and retail are two, there is only a retail business license "above the range of retail business" or "retail" character, is not reflected in the permit as a "wholesale" business.
According to "Anhui Medical Device Distribution Enterprise License Management Measures Implementation Rules (Trial)" Article 29, China electronic thermometer manufacturer "retail" is the purchase of products sold directly to consumers, usually Class II medical devices. Medical equipment supply medical products to use, China medical thermometer only a small part can be used by consumers themselves. I believe that could be considered medical license mode of operation to "wholesale and retail."
"Medical Device Distribution Enterprise License Management Measures" for medical device companies to expand business scope without the liability provisions there are two: 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 device enterprises" Beyond the "Medical Device 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, a fine of 10,000 yuan to 20,000 yuan fine. " 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, I believe, should require drug manufacturers' equipment must be purchased from the manufacturer with medical equipment or 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 establishment of the procurement of medical equipment suppliers 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; purchase of medical equipment must obtain legal bills, as required to establish a true and complete record of the purchase of medical equipment, 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.
Release management also need to avoid blind spots
In May 2005, the State Food and Drug Administration announced the first batch do not need to apply for "Medical Device Distribution Enterprise License" for Class II medical devices product catalog, a total of seven categories of 13 products.