Medical network - on December 23, according to incomplete statistics, since June 8, 2016 CFDA release about the launch since the announcement of medical instrument clinical trial supervision and spot check, a total of 122 companies to withdraw 263 for medical device registration project, July 22 clinical check list after verification for drug registration being actively withdrawn it again.
Released on December 16, 2016 CFDA 27 companies withdraw 32 for medical device registration project announcement, withdraws the time range of October 20, 2016 to December 12, 2016.
This is not the first time that the CFDA published enterprise actively withdrawn for medical device registration information of the project. Things back in June 8, 2016, the CFDA released in the form of announcement for the upcoming clinical trials for medical devices supervision and spot check, the number 98, 2016, said it would "return to check", in whose application for registration on June 1, 2016 to carry out the implementation of clinical trial projects. In selectiving examination scope, including all the third class and imported medical instruments within the territory of China by way of clinical trials for clinical trial data for registration.
The first inspection, focused on June to October in 2016, the CFDA by instalments of inspection group, according to the medical device clinical trials on-site inspection procedures to carry out the on-site inspection. October and November, it is the second batch of medical instrument clinical trial supervision and spot checks.
From 2014 to 2016, from many developed medical equipment to the relevant laws and regulations, to the various types of product registration technical guidelines launched, and then to the provincial bureau of instrument verification dense release, clinical trials will scream instrument in clinical trial quality trend of increasingly stringent regulation. The spot check, is both drug inspection check after, another country in terms of medical instrument clinical trial.
YiXie sampling, roche, abbott laboratories
Judging from the results, YiXie selectiving examination quite productive, part of the company "unfortunate" by sampling observation, the results really found the problem, be shamed.
On December 16, 2016, the administration issued a notice, according to investigate three clinical trials for medical device registration project reality problems, including equivalent biological technology co., LTD., anhui LSI MedienceCorporation Roche Diagnostics GmbH in Germany, and Japan. Investigate the cause of clinical trials for registered in three projects were found in the process of the repeated use of sample counties and townships, and is not involved in the clinical trial scheme samples, the experiment report on the sample reuse or special instructions.
The natural result is was found that the problem seriously. Administration documents, according to the regulations according to the medical device registration, the above three all exist for authenticity of the registration items shall not be registered, and since no one year from the date of registration will not be accepted again, and involving clinical test units and the related responsible for processing food drug administration at the provincial level investigation.
Roche is not only a well-known YaoXie enterprise overall. In the first batch of medical instrument clinical trial supervision and spot checks, Abbott, Germany GmbH &co. KG applied in human T lymphocyte virus type Ⅰ/Ⅱ antibody detection kit (chemiluminescence particles immunoassays) (accept no. : 15-1668) was also found that the authenticity, will eventually get the same punishment.
Voluntary recall, has involved hundreds of enterprises
According to incomplete statistics, E medicine managers since June 8, 2016 CFDA release about the launch since the announcement of medical instrument clinical trial supervision and spot check, a total of 122 companies to withdraw 263 for medical device registration project, July 22 clinical check list after verification for large-scale drug registration being actively withdrawn it again.
According to the CFDA public information, from the spot check documents released to August 25, 51 companies withdrew 101 for medical device registration project, from August 26 solstice on October 19, and 44 companies withdrew 130 applicants. The latest is withdrawn since October 20 solstice December 12, a total of 27 companies has withdrawn his application for 32.
Among them, apply for withdrawal of most German companies are ORGENTEC Diagnostika GmbH, involved 12 accept order, and products are all kits. After the enterprise of soluble liver antigen antibody assay kit (enzyme immunoassay) was pointed out that clinical trials conducted in tianjin people's hospital, not according to clinical trial scheme using serum samples, and cannot be traced, so the application is not registered.
And withdraw its most domestic enterprises is ze into biological technology co., LTD and nantong in jiangsu dell noth biological technology co., LTD., the number of 18 and 28, respectively. On October 17, 2016 CFDA approval documents will not be registered in the notice, nantong by dell, a total of nine to accept order will not be registered. |
