December 22 hearing, speaking of class I medical devices may be a lot of people are very strange, but speaking of Chinese medicine cupping cupping jar, check the throat with the tongue spatula, visual acuity chart and without lifting additional functions such as ordinary beds, the image of class I medical devices becomes intuitive - - relatively low degree of risk of the medical equipment.

Since 1996, our country to medical equipment market to implement registration management, according to the degree of medical device risk implement classification management, namely: first is the low level of risk, the implementation of routine management can ensure its safety, effective medical devices; the second kind is with moderate risk and need to strict control and management, to ensure its safety, effective medical devices; the third is with high risk, need to take special measures to strictly control and management, to ensure its safe and effective medical devices. Among the three types of medical equipment by the State Food and Drug Administration Review approval, the risk is relatively low in the second, a kind of medical apparatus and instruments listed respectively by the provincial and municipal food and drug supervision department for examination and approval.
On June 1 last year, the newly revised "medical equipment supervision and management regulations" began, will be listed in first class medical device license by the original registration and approval system changed to filing system, in the country caused great repercussions. Shanghai as a medical device industry developed, the variety of the whole, the number of municipalities, the first to complete the implementation of the new deal. Shanghai food and drug administration, medical equipment registration office director Raymond Lam said, the core of the filing system is to strengthen the main responsibility of the enterprise. Corporate commitment data authenticity, integrity, compliance, responsibility; regulatory authorities to strengthen in trace afterwards supervision and quality testing, risk control products, to protect the public safety of machinery. "
First class medical device Market
No longer implement the registration examination and approval system
According to Raymond Lam introduction, the total number of medical devices in Shanghai is located in the forefront of the country, the first class, the number of second types of medical equipment, a variety of more than. Shanghai attaches great importance to the management of medical equipment listed, is the country's first set up a medical device registry. Shanghai medical equipment brand and quality, norms and innovation is better, has been widely recognized by domestic and foreign users.
Since June 1st last year, the new medical equipment supervision and management regulations, the implementation of the management of medical equipment in China to make a significant reform. On the lower risk of the first type of medical equipment listed on the approval system into a directory for the record system.
Shanghai first medical device
Classification work has been basically completed
"The first type of medical devices registered by the record, not the competent authorities to let go regardless, but instead of the previous record and follow-up management." It is reported that in the supervision and administration of medical devices regulations "on the eve of the implementation, the State Food and drug administration also released the catalogue of the first class of medical devices, usually in the list of class I medical devices only need to record can be listed, and in addition to the directory of products, namely the once won the first class medical device registration certificate, is no longer regarded as a kind of medical apparatus and instruments. The birth of the directory to a certain extent, the concept of a class of medical devices, the only mature, the market recognized as the first class of medical equipment was income directory, the implementation of the record management.
"As long as the products in the directory within the relevant range, enterprise at the time of filing to the government for informative commitment, and for personnel in the review form to record data, the market should be Banjie. This filing is free, long-term and effective." Raymond Lam said, the first type of medical device products for the record after the production record, both can be done after the production of products, listed sales, and can be free sales, not subject to regional restrictions such as the record. Although this filing system in the early implementation of the workload is huge, but after the transition period will be more stable and smooth. On the other hand, it also puts forward the requirements to strengthen the follow-up supervision."
However, the first category of medical device product catalog has brought another problem: those who have access to the first type of medical device registration certificate, but not in the directory of products to how to deal with? In the second half of last year, the country's inspection, market, enterprises have been more at a loss. At the end of last year, the State Food and drug administration requires all has been reported to obtain registration certificate is not in the directory first class medical equipment, in the nationwide to tease out the kind of products up to 4058 products, which submitted to the Shanghai relates to 196.
, the State Food and Drug Administration of these reporting product classification, Shanghai food and drug administration to submit products in direct and clear classification of class I medical devices have 136, class II medical devices have 14, not according to the management of medical apparatus and instruments of the 18; incomplete information but can be clearly related to classification of 23; incomplete information, decision not only 5. At this point, Shanghai's first medical device classification work has been completed.
Set up a network platform
First record operation guide
In June 1st last year, the implementation of the new regulations at the beginning, Shanghai is one of the country's first implementation of the local. Since the previous examination and approval of class I medical devices and not delegated counties, the district does not have to immediately switch for filing of technical ability, so by the Municipal Food and Drug Administration medical equipment at early for unified treatment also stepping up to district staff of rotation training. At the same time, the city food and Drug Administration Bureau to proceed with the establishment of the first class of medical devices to the network platform, and elaborate the operational guidelines for the record, this is the nation's first set of "text formatting, review points program" the record