The Registrant must Assume Legal Responsibility for the Quality of the Product throughout Its Life Cycle

On June 1, the newly revised “Regulations on the Supervision and Administration of Medical Devices” was formally implemented.

In the future,the registrant must assume legal responsibility for the quality of the product throughout its life cycle,and each medical device will have a unique “Electronic ID Card” for traceability management.

The so-called “Heavy Penalty” refers to the maximum penalty of 30 times of the value of goods for illegal acts involving quality and safety.At the same time, according to the circumstances of the violation, the offender shall be punished with the revocation of the license, the prohibition of related activities for a certain period of time, and the failure to accept the relevant license application.In addition, the regulations also increase the “Punishment to People” measures, and punish the relevant responsible personnel of serious illegal units with confiscation of income, fine, five years or even life-long prohibition of relevant activities.

New regulation also aims to encourage innovation and promote high-quality industrial development. These include measures to implement informative filing and encourage medical institutions to carry out clinical trials.For example, for low-risk medical devices, informed filing is implemented, and the filing is completed after the filing person submits the information that meets the requirements.

For an English  copy of the regulation,please email info@inspirativemed.com