Healthcare Regulatory Reforms in China

Medical Device Regulations

China's National Medical Products Administration (NMPA) have published the following registration guidelines in 2019:

Changes to Market Authorization Holder Mechanism

According to the Medical Device Supervision and Administration Regulations (Draft for Comment) 2019.04, the medical device registrant shall perform the following obligations:

1. Establish a quality management system that is compatible with the product and maintain effective operation

2. Develop a continuous research and risk management plan after listing and ensure its effective implementation

3. Carry out monitoring and reevaluation of adverse events in accordance with the law

4. Establish and implement product traceability and recall system

5. Other obligations as stipulated by the drug regulatory department of the State Council.

Improvements to the Clinical Trial Management System

Currently, the three methods of clinical evaluation of medical devices are:

1. Clinical trial

2. Comparison with the same variety

3. Products exempted from clinical trial

The newly revised catalogue of medical devices exempted from clinical trial covers 855 medical device products and 393 in vitro diagnostic reagent products, with 84 new medical device products added of which 63 belong to the second class of medical device products, and 21 belong to the third class of medical device products.

Additionally, there are 277 newly added in vitro diagnostic reagents, of which 246 belong to the second class of in vitro diagnostic reagents and 31 belong to the third class of in vitro diagnostic reagents.

The following are some important precautionary notes regarding the use of the above catalogue:

1. Some product names and descriptions in the catalogue of medical devices exempted from clinical trial and product classification catalogue are different and should be confirmed;

2. Some products not only include the second class of products in catalogue of medical devices exempted from clinical trial, but also include the third class in the product classification catalogue, vice versa, so avoid misuse. Some examples are infusion pump, catheter, radiofrequency ablation electrode (for endoscopic use or non-endoscopic use).

3. The products targeted are those with mature technology, clear principle or mechanism of action and products which have been listed for many years without any serious adverse events. Generally, these products have corresponding national standards or industry standards. Exemptions do not include products that differ from the materials, technologies, designs or mechanisms of action, functions, etc. of the products already on the market.

Summary

The Medical Device Supervision and Administration Regulations are in the process of being revised. The main changes to be expected are:

• Implementation of the medical device registrant system

• Adjustment of clinical evaluation principles

• Changes in inspection report requirements

• Evaluation of overseas registrants

There are also several new initiatives in 2019, including:

• Electronic filing of registration materials

• Issuance of e-Cert

• Optimization and adjustments to the review approval process

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