The six major industry regulations that medical device practitioners must understand!
In the past six months of 2016, for the Chinese medical industry , it was a very extraordinary year in which the crisis was one after another and the industry was in turmoil. On the one hand, "the girl angrily traffickers event", "poison vaccine pieces", "Wei the West event", "Guangzhou Medical injury events" such as the spate of medical incidents, the doctor-patient relationship dropped to the freezing point, it is on the verge of doctor-patient conflicts On the other hand, the unprecedented rectification of the medical industry is well prepared. In the further implementation of the Regulations on the Management of Medical Devices, the implementation of medical device quality and circulation is more targeted, more specific and comprehensive. At the same time of rigorous industry supervision, the "two-vote system", "one-vote system", flight inspection, self-examination, and the ban on ticketing and ticketing, etc., have been carried out in a series of large-scale reforms and rectifications, so that medical equipment enterprises should be overwhelmed. Medical device practitioners are even complaining about the sky.
From the perspective of market development, the rectification and regulation of the medical device industry is imperative. As a practitioner in the medical device industry, it should be the most sensible choice. The following are the new rules for the notifications, announcements, and solicitation of opinions on medical devices issued by the CFDA since May. The medical device industry practitioners should fully implement the new policies and regulations. Implement its guiding ideology, guide enterprises to engage in more standardized production and business activities, and seek more market opportunities for the development of enterprises.
Summary of CFDA medical device notifications, announcements, and consultation drafts
1. Announcement of the General Administration on rectifying the business operations in the field of medical device circulation
In order to standardize the order of medical equipment circulation and severely crack down on illegal business operations, the State Food and Drug Administration has decided to carry out centralized rectification of illegal business operations in the field of medical device circulation. From June 1st, 2016, all the second- and third-class medical device operators will carry out self-examination of the company from eight aspects.
Before July 15, 2016, the medical device operating enterprises that can actively find problems and correct other violations of laws and regulations may be lightened or mitigated according to law; if they fail to report, the municipal food and drug supervision departments in the district shall go to the society. The list of open enterprises shall be listed as the key inspection object; for those who refuse to report, report false reports, and do not seriously investigate and correct the rectification, strictly, from the re-examination, until the revocation of the "Medical Device Business License"; In case of specific behaviors, if the circumstances are serious, the Medical Device Operation Permit shall be revoked in accordance with the relevant provisions of Articles 63, 66, 67 and 68 of the Regulations on the Supervision and Administration of Medical Devices. If the society is suspected of committing a crime, it shall be handed over to the public security organ; if there is a serious violation of law or dishonesty in the medical device operating enterprise, joint punishment shall be implemented in accordance with relevant regulations.
2. Notice of the General Office of the General Administration on the timely disclosure of the registration information of the second type of medical devices and the filing information of the first type of medical device products
The food and drug supervision administrations of all provinces (autonomous regions and municipalities) shall continue to earnestly do a good job in registering information on the second type of medical device registration and the first type of medical device filing information, and upload relevant data to the medical device registration database of the State Administration of Taxation in a timely manner. The State Administration of Taxation will regularly check the reported data and report to the provincial (regional, municipal) Food and Drug Administration with more problems. In the evaluation of the evaluation capacity of medical equipment at the provincial level, which will be carried out in 2016, the data upload will be an important assessment content.
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