The shocking day, CFDA to stop the import of two medical device products

December 15 hearing December 14, very shocking, CFDA issued two notices, to suspend the two imports from the UK medical device products.

Stop importing is not surprising at all drug There have been many occasions.

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.

One country medicine , medical instruments Products to be exported to another country, of course, to comply with the relevant importing country standards and regulations, these provisions will include research and development, production, sales and other links. Can not do that, then 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 for import, it means being temporarily denied outside the country.

Prior to the end of November, CFDA had issued a circular in the overseas inspection, the five medical device company's products are flawed, more or less there is a problem, CFDA ordered enterprise Rectification, but none of them reached such a serious degree as "suspension of imports." For more information, see:

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 (immunohistochemical method) from Leica Microsystems and handle them according to law.

We undoubtedly need outstanding medical device products from all countries. The medical device enterprises in various countries naturally need this big market in China. Along with the Chinese pharmaceutical industry Regulations Is accelerating with international standards, medical device inspectors team more and more professional, international, global medical device companies in the future global inspection or will become the norm, that day, we will never feel fuss.