December 14, very shocking, CFDA issued two notices, the suspension of two imports from the UK medical device products.
It is not surprising to stop importing, and there have been many times in medicine.
But this time, the reason for stopping the import of medical device products may be unprecedented in history.
This is because the CFDA conducted on-site inspections on imported medical devices and found that there were problems with the products. It allegedly violated the relevant administrative regulations in China and suspended the import for the sake of safeguarding public safety.
For a long time, our supervision over the production process of medical devices is relatively weak. Many enterprises aim to obtain GMP certificates. However, whether the production process has been conducted in accordance with the GMP standards and the current team of drug supervisors must be unable to monitor them timely of.
In recent years, the drug regulatory department has strengthened the combined use of flying inspection, sampling inspection and daily inspection. The number of CFDA inspection team members is also constantly increasing, which greatly strengthened the monitoring of production processes.
In addition to the national bureau level, the inspection of the provincial bureau and municipal bureau has also become normalized. As a result, a large number of domestic medical device manufacturers have been punished for remediation, investigation, and even the cessation of production.
However, the sales of medical devices in the Chinese market, is it only the domestic enterprises in the production of? Check the local production enterprises is very much, but the imported products of the production company? Do their production must be qualified, it must be In line with China's management practices? Only check the local enterprises, it is not fair.
If a country's pharmaceutical and medical device products are to be exported to another country, they must naturally comply with the relevant standards and regulations of the importing country. These provisions should include all aspects of research and development, production and sales, and do not come in.
CFDA should have the layout of this early.With the establishment of the inspectors team, check the level and ability to continuously improve the formation of the international team of inspectors, it is time to shot!
These inspectors are the 'eyes' of 1.4 billion people. In order to guarantee the life and health of these 1.4 billion people, they have found problems and handled the problems in a decisive and unambiguous manner.
It can be said that this is the CFDA this year officially cross-border medical equipment manufacturing inspections, the two cases currently being the most serious punishment - was suspended imports, which means temporarily being denied outside the country.
Prior to the end of November, the CFDA issued a circular. During the overseas inspection, the defects of five medical device companies were more or less problematic. The CFDA ordered the enterprise to rectify the problem, but none of them had reached such a serious degree of suspension of imports. See: Drug Administration Overseas Bright Sword, checked 5 machinery enterprises
Two of the products that were stopped for import this time, one was registered by Biocomposites Ltd. in China. Calcium sulfate and resorbable artificial bone meal were registered separately. However, both products were found in the form of a combination package Sent to China for sale, its packaging of syringes and water for injection is not registered in China, and declare the registration of the product is inconsistent, alleged violation of the "Regulations on the Supervision and Administration of Medical Devices" and "Medical Device Registration Regulations" of the relevant provisions.
CFDA announced that from now on, it will suspend the import of calcium sulfate and resorbable artificial bone meal by Baise Company in the form of combination packs, and organize the investigation and handling according to law on clues of relevant cases.
Another product, the HER-2 Assay Kit (immunohistochemistry) by Leica Biosystems Newcastle Ltd, has been modified from its primary source of mouse IgG and hydrogen peroxide suppliers, Violated the relevant provisions of China's "In vitro diagnostic reagents registration management approach".
CFDA announced that as of today, the company will suspend the importation of HER-2 detection kit (immunohistochemistry) from Leica Microsystems and handle the cases according to law.
We undoubtedly need excellent medical device products from all over the world. Medical device companies in various countries naturally need this big market in China. With the regulations of Chinese pharmaceutical industry accelerating with international standards, the team of medical device inspectors has become increasingly professional and international , The future of global medical device inspection company or will become the norm, that day, we will never feel fuss.
