Fujian Province issued a notice to deploy the quality and safety of medical devices special rectification work. The notice requires that, in accordance with the working principles of "risk management, full control, scientific supervision, social *** governance", continue to strengthen the supervision and management of key products such as medical devices, registrants entrusted production and other key enterprises, network sales and other key links and medical cosmetic use of key areas, improve the operational mechanism, enhance the regulatory capacity, and strictly investigate violations of law and regulations.
The notice specifies ten key tasks of the medical device special rectification work. Among them, in the specific population use of medical devices regulation, focusing on corneal contact lenses (including decorative color contact lenses) and their care products, ophthalmic medical devices and other youth myopia prevention and treatment of related medical devices. Around the medical device network sales link, focusing on the investigation of medical devices, complaints and reports and public opinion more concentrated medical devices, strict inspection of the third-party platform to fulfill the legal obligations. At the same time, to strictly investigate violations, continue to promote special rectification of drug safety, strengthen the daily supervision and inspection and law enforcement interface, focus on combating and remedying unlicensed production and operation, operation and use of unregistered or filed medical devices and other violations, focusing on the medical and cosmetic medical devices and other complaints and reports of a more concentrated product, digging into the clues, in-depth investigations, and seriously disposed of.
In addition, the ten key tasks also include strengthening the epidemic prevention and control of medical devices, centralized band purchasing selected medical devices and other key varieties, as well as medical device registrants commissioned the production of innovative medical devices, innovative medical device companies, production and operation of major changes in the supervision and management of key enterprises and other seven tasks.
In order to ensure that the special rectification is carried out efficiently, the notice also puts forward the implementation of the main responsibility, to promote the risk of consultation, strengthen the system of inspection, strengthen the sampling and monitoring, to carry out demonstration and creation, and crack down on illegal and irregular behaviors and strengthen the assessment and evaluation of the seven work measures.