Proposed Medical Device Legislative Changes in China

By Amber Baade and Janet Zhang

Background

In China, a series of State Orders have been promulgated to establish the legislative basis for medical device requirements. The current State Order is State Council Order No. 739, Regulations for the Supervision and Administration of Medical Devices.

The NMPA has published a draft Medical Device Management Law (Aug. 28,) for public comment.

Draft Law Compared to State Order

Unlike a State Order, the proposed Law signifies the importance of the legislation for medical devices. This will elevate the management of medical devices, enhancing the binding force and enforcement of the provisions. The objective of this Law is to ensure the safety and effectiveness of medical devices and to promote high-quality development of the industry.

In addition, the proposed revisions remove some of the administrative burdens related to regulatory requirements and encourage novel and innovative devices in China.

Proposed Provisions in the Law

Significant changes have been proposed, with a few to highlight.

Provisions have been proposed to encourage industry to market novel devices in China (Articles 4-6, 43). This includes the advancement of global Randomized Controlled Trials (RCT) and the use of RCT data for registration in China.

Some of the more administrative burdens have been removed: electronic Instructions for Use are also accepted (Article 33), and licenses can be transferred (Article 58). The Country of Origin (COO) requirement has been removed for devices that are not novel: it may now be possible to launch any new products, regardless of whether the devices are innovative, first in China.

Regulatory responsibilities have been imposed on the local representative (Article 47, 88).

Concluding Remarks

This is a significant proposal to foster the medical device industry in China. The draft is open for public comment until Sept. 28.

Emergo will continue to monitor and share regulatory developments.