Overview of Medical Device Classification in China
Compared with the previous catalog system, the key changes are:
- The number of device categories have decreased from 43 to 22.
- 1,157 subcategories have been added.
- Product description and intended use have been added to determine the right classification. Furthermore, the difference between the sterilized device and the non-sterilized device, under the same category and subcategory, are now shown in the product description.
- More examples of device names are provided. The number of device names has increased from 1,008 to 6,609.
- There are 40 reclassifications.
- AI diagnostic is added.
Effective August 1, 2018, the previous classification catalog for Class II and III devices have become obsolete. Class I device classification now relies not only on the new catalog but also on other resources that are currently available. It should also be noted that the new catalog only applies to medical devices. The existing NMPA (CFDA) catalog system continues to work for IVD products. For your questions regarding IVD classifications, please email us at info@ChinaMedDevice.com.
China Medical Device Classes & Categories
In China, all medical devices are divided into three classes by their risk levels:
Class I
Low-risk medical devices whose safety and effectiveness are ensured through routine administration.
Class II
Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.
Class III
High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness
Overseas Medical Device Registration in China
Overseas medical device manufactures are required to furnish NMPA (CFDA) with product samples for testing and registration. For Class II and Class III devices, manufacturers also need to present proof to NMPA (CFDA) that the device has already been approved and registered in its country of origin. This may include CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application, etc. In addition, NMPA (CFDA) may also request manufacturers to provide clinical data along with the device application in China. It is also worth noting that all product information, including what is shown on product packaging and product labeling must be translated and presented in Simplified Chinese. Currently, the validation period for registered medical devices in China is 5 years. A renewal application must be submitted to NMPA (CFDA) 6 months prior to the expiration date. Manufacturers are also required to hire China-based agents to present products in China. The local agent will work on the manufacturer’s behalf in order to: oversee the registration process, provide technical service and product support, assist with device recalls, provide support in case adverse events occur, due to device malfunction.
China Medical Device Classification Catalog
The current China medical device classification catalog also classifies products into 22 categories:
- Active surgical
- Passive surgical device
- Neuro & cardio surgical device
- Ortho surgical device
- Radiation device
- Imaging device
- Diagnostic & monitoring device
- Anesthesia device
- Physiotherapy device
- Infusion & dialysis devicev
- Sterilization device
- Active implantable device
- Non-active implantable device
- Nursing and protective device
- Bed and transportation device
- Ophthalmic device
- Dental device
- Gynecological and obstetric device
- Rehabilitation device
- Traditional Chinese medical device
- Software
- Laboratory device
Advantages of China’s 2018 Medical Device Classification System
When compared with the previous classification system, China Med Device believes NMPA (CFDA)’s 2018 medical device catalog revisions brought in several advantages. For instance;
- The classification structure is a better match to clinical practice
- Additional product key info better identifies and describes each medical device
- Product name examples increase and provide boarder coverage.
NMPA Medical Device Registration & Clinical Trial Process
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