In 2018, the six major medical device regulations to change!

Pharmaceutical Network February 13 News February 12, the State Administration of Drug Control announced the 2018 legislative plan.

In 2018, the total number of legislative projects of the General Administration of Drug Rehabilitation is 36, among them medical instruments Directly related to 6, including:

We will speed up the revision of the "Regulations on the Supervision and Administration of Medical Devices" and strive to submit draft amendments to the State Council in the first quarter.

In the above-mentioned laws and regulations to be revised by the State Administration of Work Safety, the "mother law" in our industry - the draft amendment to the "Regulations on the Supervision and Administration of Medical Devices" was publicly discussed at the end of last year and the relevant draft The contents of the General Administration website also.

Industry 'mother law' the changes, the intensity is not small, there are three major changes point:

First, an increase of medical equipment enterprise And the use of units and other intentional, major violations of the law, related businesses and units have to be fine and other personnel to be penalized content;

Second, it is clearly stated that the operation of second-hand operation and refurbishment of medical equipment should be banned.

The third is the import of medical equipment and its agents put forward many measures to strengthen supervision.

From the administration's legislative plan and combined with the existing information, the revision of the regulations on the production, operation and registration of medical devices should be related to the revision of the "Regulations on the Supervision and Administration of Medical Devices" Make changes to the content adjustment.

As for "imported medical equipment proxy People supervision and management approach "this year will be developed a new regulation, highly targeted, the introduction of its means that the import agency strict control of the times really want to come.