State Council Introduces "Secure and Controllable" Requirement in Medical Device Approval System

Last week, the State Council published a set of guidelines aimed at reforming the system of approvals for medical products and devices. The new policy, issued as a set of State Council Opinions, was republished by MIIT and featured on numerous government ministry websites this week.

While much of the policy is aimed at solving a backlog of new product approvals and stemming the illegal sale of counterfeit medical goods, there is a reference to "secure and controllable" requirements in the section pertaining to medical device approval.

Chapter 15, which focuses on the reform of the approval process for new medical devices, calls on government ministries to help improve the quality of domestically produced medical devices. The Opinions state: 

"Through a new product classification system, the China Food and Drug Administration will delegate the approval of certain mature, secure and controllable medical devices to provincial level government."