Order No. 29 of the State Food and Drug Administration - "Administrative Measures for Medical Device Recall" was officially implemented on May 1. The order clearly stipulates that the subject of the recall involves the domestic registered medical device registrant and the designated agent of the foreign medical device. That is to say, in the past, it was often seen that only the defects of foreign-funded enterprises and enterprises were publicly recalled, and the CFDA will also publish them on the spot. In the future, it will spread to all domestic-funded enterprises, and the recall will become a mandatory measure.
The implementation of the order will completely end the state of the local machinery enterprises in the past, even if there are quality problems, it is rare to recall, and must be recalled, otherwise it will be sanctioned by regulations.
Since 2015, the supervision of medical devices by the drug regulatory system has gradually shifted to the production of, circulation, and use of the entire process of random random inspection, as well as frequent sampling and daily inspections. There are quite a few products that do not meet the standards in the local medical device sampling. At the CFDA flight inspection level, nine “Quality Announcements†have been published this year, and there are more in the provincial inspections that do not meet the standards.
What is certain is that with the strengthening of flight inspection, sampling inspection and daily inspection, the possibility of quality problems and quality defects being exposed in China's 18,000 medical device manufacturers will increase greatly.
But until now, local medical device companies rarely see recalls for products that do not meet the standards, and there are few recalls of defective products.
Since January 1, 2016, the CFDA has announced that the recall of domestic medical devices is only one of Shanghai Shangke Kangge Medical Equipment Co., Ltd., and the rest are foreign-owned mechanical enterprises or domestic agents. In addition, in November last year, there was a case of domestic medical equipment in Sichuan that was required to be forcibly recalled.
Can it be said that the quality of our products produced by more than 10,000 local machinery companies is better than imported ones? It is up to this committee to say that no one will believe it. But why is it so difficult to recall?
In the interview, the deputy secretary-general of the China Pharmaceutical Materials Association believed that the main reason for this was that the regulations were still being drafted and reviewed, and it was still not perfect. At the same time, the penalties for refusal to recall the machinery enterprises were limited.
Which products are recalled?
The regulations issued this time describe the medical devices that are defective and need to be recalled as:
Products with unreasonable risks that may endanger human health and life safety under normal use;
Products that do not meet the technical requirements for mandatory standards, registered or filed products;
Products that do not meet the relevant regulations on the production and operation quality of medical devices, which may lead to unreasonable risks;
Other products that need to be recalled.
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