On May 11, 2017, the Standards Regulation Center in Beijing organized a meeting on how to prepare training materials for the new and pending release “Medical Device Classification Directory”. The leaders from CFDA and the Standards Regulation Center along with the responsible people for the sub-directory revised work units, more than 50 people attended the meeting. CFDA commissioner, Wang Lanming, attended the meeting and talked about the importance of thoroughly prepare the training materials for the implementation of the new Medical Device Classification Directory.
CFDA “Medical Device Classification Directory (revised) ” was issued for feedback with due date on November 25, 2016.
The revised medical device classification directory has significant implications for medical devices registrations or renewals. If your devices are not included in the revised directory, you must go through the expert panel forum to get the proper classification. Expert panel could be time-consuming and costly
This newly released revised draft directory has been in the works for the past seven years. It was finally released for industry feedback. The previous directory was released in 2002. It is very dated and lacks details and clarity. It fails to keep up with the rapid proliferation of medical devices and the growth of complex technologies that have taken place in China.
The revised directory has 22 subdirectories. It consolidated and reduced the 2002 version’s 43 subdirectories by 19. Under each of the 22 subdirectories, there are further detailed divisions. Here are a few examples of how to look at the categories.
1. Surgical instruments category has four sub-categories:
- surgical instruments with electronics (active)
- surgical instruments without electronics (passive)
- nerve and vascular surgical instruments: contacts with nerve and vascular type of equipment have special requirements so it has its category.
- orthopedic surgery-related devices: due to its complexity, high volume and a wide range of products, it has its own category.
2. Devices with electronics appeared in 8 different categories primarily:
- radiation therapy equipment
- medical imaging equipment
- medical examination and monitoring equipment
- respiratory, anesthesia and first-aid equipment.
- physical therapy equipment
- blood transfusion, dialysis and cardiopulmonary bypass equipment
- medical equipment disinfection and sterilization equipment
- active implant device.
3. Devices without electronics appeared in 3 different categories primarily:
- Passive implant devices
- infusion, care and protective equipment
- patient-carrying devices
4. Devices by clinical departments:
- ophthalmic devices
- dental instruments
- Obstetrics and Gynecology, reproductive and contraceptive devices.
It is worth pointing out that Medical Software has its own category for independent operating software, different from the sub-directory of medical independent software products.
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