Address:No. 1188, Jiaer Road, Jiutai Economic Development Zone, Changchun
Feb 24-25, 2016, the Standard Management Institute of Medical Devices of China’s Food and Drug Verification Research Institute organized work inquisition meeting of advice revision (first batch) on medical devices category.
New edition Medical Devices Category Contents is expected to be issued this year.
It is mentioned that: China Food and Drug Administration issued Medical Devices Category Rules, and took effect from Jan 1, 2016. If revision of medical devices category contents goes well, new edition Medical Devices Category Contents is expected to be issued in 2016.
In addition, relevant person also disclosed concrete progress:
1. Revision work group of medical devices category contents has been formed equipped with personnel and office conditions. Revision is ongoing.
2. Adjust former 43 medical devices sub-contents to present 22 sub-contents, finishing revision of 11 sub-contents preliminary. First draft of relevant sub-contents has finished in advance, revised schedule much faster than expected.
3. Name of first and second contents has been established, and framework of sub-contents is more with perspectiveness and scientificity.
4. Dynamic database needed by amendment having been founded, medical device registration data information referred to category contents amendment gets arrangement and extract.
What effect could be on medical device enterprise?
It is well-known that our medical device category carries out category contents system guided by category rule, category rule and category contents side by side, and category contents in priority.
However, medical device category is the base and source of medical device management. Aforementioned new edition Medical Devices Category Rule has been published, and it still has trouble in the application of category for its macroscopic and abstract contents.
The issue of new edition Medical Devices Category Contents helps many enterprises bothered by category issues.
New edition Medical Devices Category Rules pinpoints affiliation of some products, directing R&D and production of enterprises. Product description, intended use and name example of sub-category in new edition Medical Devices Category Contents directs enterprises to do correct category in a further way for market arrangement.