At present, there are many problems in the supervision of medical devices in my country. Some medical device production, operation, and use units have weak legal awareness, low self-discipline awareness, and some violations. Medical device supervision is inadequate and lacks the necessary medical device professional knowledge, which brings certain difficulties to the supervision work. There are many types of medical devices, including a large number of high-tech products with high technological content, which involve multi-disciplinary fields such as electronic technology, optical technology, information technology, engineering, biology, and medicine.
As small as a surgical needle, suture, or extracorporeal reagents (such as blood cell reagents, biochemical reagents, electrolyte reagents, urine sediment reagents, cleaning solution), as well as nuclear magnetic resonance, CT machine, all belong to medical equipment Management, which requires corresponding professional technicians or compound talents with multi-disciplinary expertise, can effectively supervise and inspect the quality and performance of various medical devices.
Moreover, the development of the medical device classification catalog is not conducive to supervision. The current classification catalogue only defines the requirements for medical devices in principle. It is unclear whether a specific variety belongs to a medical device, and which type of medical device should belong to it. In actual supervision work, we often encounter plausible phenomena, so various places often submit written requests to the State Food and Drug Administration.
From time to time, the State Food and Drug Administration has issued a document "patch" to clarify the classification of a certain product. Over time, the "patch" of the State Food and Drug Administration has appeared inevitable self-contradictions. And because of the grading responsible for approval and registration, the standards held by different regions are different. It often happens that the same product is registered in different categories in various regions, which brings great difficulty to the market supervision of grass-roots bureaus.
Faced with these problems, the emergence of the new version of the regulations is a good opportunity for the medical device industry. The upcoming regulations will comprehensively cover the R&D, production, circulation, and use of medical devices.The R&D link includes the introduction of a high-risk medical device catalog, the addition of clinical review procedures, accredited medical device clinical trial institutions, and innovative medical device special review procedures, etc. The production link includes GMP certification, etc.; the circulation link includes Internet sales, third-party logistics, and management quality management standards; the use link includes the establishment of a yellow-black list, comprehensive start of electronic supervision, adverse event monitoring, and product recalls.
The upcoming news of the new version of the regulations is quite encouraging for the industry. The industry should seize this opportunity and strictly abide by the new regulations. I believe that with the support and supervision of the new regulations, the medical device industry will surely achieve better development.
