The National Medical Products Administration implements the “four most stringent” and promotes the investigation and handling of medical devices related cases.
On June 15, the National medical products administration issued the "Notice of the General Department of the Nationalmedical products administration on the Investigation and Handling of medical device related Cases, strictly crack down on violations of laws and regulations, and effectively strengthen drug safety supervision. The noticerequires that drug regulatory departments at all levels should further implement the supervisory authority, completes the inspection and audit work,strengthen cooperate with public security departments, strengthen the administrative punishment decision execution, strictly implement the"punishment to the specific personnel" rules, prevent and controlrisks in major cases, and strengthen the supporting guarantee for investigation and handling of medical device related cases.
Heavy fines set off alarm bells for hospitals that use unlicensed medical device
On August 1, 2016, local food and Drug Administration of LinZhang inspected LinZhang maternal and child health care hospital according to public report. After investigation, the hospital received an administrative penalty of 17.654 million yuan for the use of unregistered medical devices, which sound the warning bell for the entire medical device industry.
Hospitals should be cautious and not to use unregistered medical devices
It is necessary to make sure that the medical device you used can meet the national standards, whether they are obsolete or registered. According to Article 40 of the regulations on the supervision and administration of medical devices, the unit using medical devices shall not handle or use the medical devices that are not registered according to law; Article 66 clearly stipulates that if a medical institution use unregistered medical devices, the administrative department of the drug administration shall order it to stop, and the maximum penalty may be 10 times the value of the unqualified products. Article 27 of the measures for quality supervision and management of the use of medical devices clearly stipulates the punishment for “using unregistered medical devices”, which came into effect on February 1, 2016.
PGT-A kit has been enlisted for the national mandatory medical industry standards.
The Class-III medical devices are the highest level of medical devices and must be strictly controlled. They refer to the medical devices implanted into the human body to support and maintain life, have potential risks to the human body, and their safety and effectiveness must be strictly controlled.
There is already approved PGS kit according to the official website of the State Drug Administration. According to the mandatory provisions of relevant national medical device laws, any medical institution (including hospitals, medical laboratories, medical testing centers, etc.) should use registered medical devices when carrying out clinical application projects and the platform used for product development must also obtain medical device registration certificate.
Both enterprises and medical institutions should take a very cautious approach for medical devices. The State encourages the research and innovation of medical devices. The development of medical devices shall follow the principles of safety, effectiveness and economy.