Heavily Fined 5.62 Million! MoreThan Ten Million Medical Equipment Products of Mechanical Enterprises Are Not in Compliance

On March 31, a Decision on Administrative Punishment issued by Guizhou Provincial Drug Administration showed that more than 10.12 million disposable medical surgical masks of Guizhou Junjiang Industrial Co., Ltd. were fined nearly 5.62 million yuan for failing to organize production and sterilization as required.

The State Bureau of Market Supervision takes action，and the punishment intensity upgrades again

In response to the production and operation supervision and management of medical device, recently, the State Administration of Market Supervision also releases the revised Measures for the Supervision and Management of Medical Device Production

Supervision (hereinafter referred to as the Measures) and the Measures for the Supervision and Management of Medical Device Management，which will come into force on May 1, 2022.

The two measures strictly implement the “four strictest” requirements, implement the provisions of the regulations on the supervision and administration of medical devices, fully implement the filing system of medical device registrants, optimize the administrative licensing process, strengthen supervision and inspection measures, improve supervision and inspection means, consolidate the responsibility of enterprises, and further strengthen the punishment of illegal acts.

In addition to the legal responsibilities stipulated in the Regulations on the Supervision and Administration of Medical Devices, the measures also adds two punishment provisions.

First, for the medical device manufacturing enterprises that fail to report the variety of products and relevant information in accordance with the provisions of the Measures, or that stop production for more than one year and no similar products are in production, and fail to carry out necessary verification and confirmation and report to the local drug regulatory department during re production, the drug regulatory department shall give a warning and impose a fine of more than 10000 yuan and less than 50000 yuan according to its duties;

Second, for those who fail to change the registration items of the production license of medical devices in accordance with the provisions of the Measures, or who fail to organize the code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices, the drug regulatory department shall order them to make corrections within a time limit according to their duties. If they refuse to make corrections, they shall be fined not less than 10000 yuan but not more than 50000 yuan. If the circumstances are serious, they shall be fined not less than 50000 yuan but not more than 100000 yuan.

It is worth mentioning that since 2022, the verification center of the State Food and drug administration has announced three rounds of flight inspection of medical devices, and 21 machinery enterprises have been identified. With the formal implementation of the new regulations on May 1, a new round of medical device flight inspection will follow. For medical device enterprises, there is no doubt that they can only conduct self-examination and rectification at all times to standardize themselves.

Source: Medical Device Dealer Alliance

Editted and translated by  BradyKnows

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