However, for the rectification, it should be some good news for companies and practitioners who operate legally and aspire to be medical devices, which can further improve the industry market of medical devices in Hunan Province, and improve the credibility of the industry and its development.
With regard to whether the current reporting conditions will be adjusted after the rectification, we can only wait for the notification from the provincial bureau, and generally speaking, it should be improved.
It is recommended to pay attention to the relevant news of the provincial bureau from time to time, or pay attention to the official website of Gaiser Junbao. We will update some new information and dynamics of the industry.
Excerpts from the original notice are as follows:
Notice on matters related to the implementation of the rectification of the medical device market circulation order special governance activities
Cities and states Food and Drug Administration:
According to the provincial Corrective Mechanism Office of the "on the province to carry out the rectification of the standardization of the order of the circulation of the drug and medical device market special governance work notice" (Hunan Corrective Mechanism Office issued by the 2013) document spirit.
According to the provincial corrective action office "on the province to carry out rectification and standardization of drugs, medical equipment market circulation order special governance work notice" (Xiang纠办发20113)文件精神，为全面、深入、扎实地开展整顿和规范医疗器械市场秩序专项行动，切实强强省省医疗器械安全监管，严厉击制售假劣医疗器械等违法违规行为，推动医疗器械市场秩序进一步好转，保障人民群众用械安全有效，现就开展整顿医疗器械市场流通秩序专项治理活动有关事项通知 As follows:
One, each unit to study and implement the provincial disciplinary committee of the eighth plenary session of the ninth and the province's anti-corruption work conference and the province's corrective work deployment arrangements, through the cleanup and standardization, so that the province's medical device market circulation order to be further standardized, the medical device market circulation order to be effectively regulated, the medical device purchase and sale of illegal and irregular behavior in the field of effective containment.
Second, the city and state bureaus should be based on the "2011 province's medical device business daily supervision program" requirements, the implementation of the work of the objectives, to strengthen the supervision and inspection of medical equipment business enterprises under the jurisdiction of the six-month daily supervision of the work of a scheduling.
Three, highlighting the focus of the work to strengthen the supervision of high-risk medical device products. Focus on checking whether the enterprise has the following problems: the sale of medical devices without "medical device product registration certificate" and other qualification documents or qualification documents do not comply with the provisions of the medical device; the sale of counterfeit, counterfeit, expired, prohibited elimination and labeling instructions and other non-compliance with the provisions of the medical device; altered, forged, rented, loaned, transferred, relying on the license to engage in medical device business activities; unauthorized changes in the name of the company, the business Registered address, warehouse address, legal representative, responsible person, responsible person for quality and over the scope of medical devices; for other units and individuals to provide sales authorization letter, qualification documents to engage in medical device business activities or for its ticket, over the ticket, on behalf of the sales invoices; the purchase of medical devices from illegal channels or to the unlicensed units and individuals to sell medical devices; purchasing, acceptance and sales records are not in line with the requirements of the storage The contents of the records are false; the person in charge of the enterprise, the person in charge of quality or practitioners do not meet the requirements of the regulations, the person in charge of quality and the person in charge of the quality management organization is not on duty or fails to perform the job duties; in vitro diagnostic reagents that need to be refrigerated are not stored according to the storage requirements and so on. Problems found during the inspection will be investigated and dealt with according to the law.
Four, in order to solidly carry out a good rectification of the medical device market circulation order of the special management work, from the date of issuance of the document to September 30th, suspend the medical device business enterprise new start-up licensing matters, the cities and states will not accept the start of the application of the medical device business enterprise.
Hunan Food and Drug Administration
July 11, 2011
The above information is provided by Gaiser Junbao.