China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use.” Compared with the previous catalog system, the key changes are:
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.
In China, all medical devices are divided into three classes by their risk levels:
Low-risk medical devices whose safety and effectiveness are ensured through routine administration.
Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.
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
The current China medical device classification catalog also classifies products into 22 categories:
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.
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;
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we represent manufacturers for the complete product life cycle without their need to create a local entity in China. Specifically, our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.