Major changes in medical supervision regulations! Fined individuals, blocking old medical devices and punishing imports

"Medical Device Industry Law" of the "medical device supervision and management regulations" have to be modified.

October 31, the State Drug Administration in its official website to hang out "medical device supervision and management regulations amendments (draft draft)", for the public to solicit opinions.

The revision of a lot of efforts, in May 2017 through the revised version of the above, a number of content has been a major adjustment.

First, the implementation of the central instructions on the spirit of the "draft" additional punishment to the specific terms of the people, medical equipment business, the use of units deliberately, a major violation of the relevant business personnel to be fined.

In the above picture, it is a new addition to the "Regulations on the Supervision and Administration of Medical Devices" compared with the "Draft".

Penalties to be based on evidence, the medical staff to be careful, the unit will no longer be exempt from personal 'amulet'.

Second, the "Draft for Commenting on the Exposure" clearly states that medical device operators should not operate medical devices that have been used, clarify their legal responsibilities, correct the light ones, and confiscate illegally-operating medical devices. If the circumstances are serious, it shall be ordered to suspend business until the business license is revoked.

The red part of the picture for the modified content, operating companies can not operate the old medical equipment.

Figure, operating the old medical equipment, fines up to the value of the amount of 10 times.

Once the amendment has been approved, the industry's second-hand operation, refurbished medical device behavior, should be completely blocked.

And second-hand, refurbished equipment, mostly involving more expensive medical equipment, such as color Doppler ultrasound, CT machine, the value of the goods on the high, offenders will face heavy penalties.

Import agent 'responsibility in the shoulder', offenders can be fine, the industry ban

Third, the "draft" for the import of medical equipment and its agents put forward a number of intensive supervision measures to clarify the import agent should fulfill the obligations, but also clear how to hold the duties of poor performance duties.

This is the "draft" new content, on the import agent should fulfill the obligations of the provisions.

The marked part of the figure is modified.

In China listed on the sale of medical equipment, regardless of domestic, imported, to 'treat' the same.

This is a new addition to the contents of the imported products in violation of medical equipment GMP Prescribed penalties.

This is also a new addition to the contents of the import proxy Indebted poor punishment.

Import agent violates "medical instruments Supervision and management regulations, "the provisions will be ordered to correct, fine 5-10 million; refused to correct, to suspend the import of related medical equipment; the circumstances are serious, 5 years of industry ban.

Finally, the "comments" content has changed a lot, including:

Improve the license system for medical devices listed on the license, set the provisions of the provisions of the registrant and filing conditions and the specific obligations should be fulfilled;

On some of the second category of medical equipment, to be exempted from operating for the record;

Clearly stipulates that the failure to carry out the event monitoring or post-marketing research, re-evaluation, can not guarantee the product safe and effective, not to continue registration;

The third type of high-risk products clinical trial approval by the express permission to implied permission;

Increase the clinical trial data to accept the clinical trials of medical equipment to expand the use of the provisions;

On the domestic and foreign unlisted innovative medical equipment, no longer require proof of overseas listing sales;