Banned for 10 Years, Fined Millions，All Medical Device Workers Must Pay Attention
2022-07-26
Non-compliance with the system and penalties to the person!
Recently, the NMPA held a meeting of the leading group for the special rectification of drug safety. The meeting made arrangements for the key work of the next stage of the special drug safety rectification action, which mentioned that it will focus on investigating and handling major and important cases, continue to increase law enforcement and case handling, severely crack down on violations of laws and regulations, implement the requirements of punishing illegal acts to people, and resolutely deal with outstanding problems.
Reason for punishment: the machinery enterprise has not set up a quality management system and kept effective operation
Punishment result:
The enterprise was ordered to suspend production and business for 3 months; fined 840,000 yuan; revoked the registration certificate of medical disposable protective clothing; the legal person Fu Zhifan was confiscated 4,500 yuan of illegal income, fined 13,500 yuan, and banned it from engaging in medical device production and business activities within 10 years; Lin shubing，enterprise inspector was confiscated 4,000 yuan of illegal income and fined 12,000 yuan, and prohibited from engaging in medical device production and business activities within 10 years.
Basis of punishment:
By the provisions of Item 2 of Article 86 of the Regulations on supervision and Administration of Medical Devices (Order no. 739 of The State Council of the People’s Republic of China) and Item 2 of Article 28 of the Administrative Punishment Law
Punishment result:
The enterprise was confiscated 23,550 yuan of illegal income, fined 471,000 yuan, revoked the registration certificate of medical disposable protective clothing, and ordered to suspend production and business for 3 months; the legal representative Zhang Ziyong was confiscated 4,500 yuan of illegal income and fined 13,500 yuan; the company inspector Zhang Yunping was confiscated 2600 yuan of illegal income and fined 7,800 yuan.
Basis of punishment:
By the provisions of Item 2 of Article 86 of the Regulations on Supervision and Administration of Medical Devices (Order no. 739 of The State Council of the People’s Republic of China) and Item 2 of Article 28 of the Administrative Punishment Law
Article 86 of the Regulations on supervision and Administration of Medical Devices
Under any of the following circumstances, the Department in charge of drug supervision and administration shall order it to make corrections and confiscate the medical devices used in illegal production and operation; If the value of medical devices used in illegal production and operation is less than 10000 yuan, a fine of not less than 20000 yuan but not more than 50000 yuan shall be imposed; If the value of goods is more than 10000 yuan, a fine of more than 5 times and less than 20 times the value of goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business until the original license issuing department revokes the medical device registration certificate, medical device production license and medical device business license. The legal representative, main person in charge, directly responsible person in charge and other responsible persons of the illegal unit shall be confiscated of the income obtained from the unit during the period of the illegal act, and a fine of more than 30% and less than 3 times the income obtained shall be imposed, it is forbidden to engage in the production and operation of medical devices within 10 years:
I. Producing, running and using medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products.
II. Not organize production by the registered or filed product technical requirements or not to establish a quality management system and maintain effective operation in accordance with the provisions of these regulations, which affects the safety and effectiveness of products.
III. Operating or using medical devices without qualification certificates, expired, ineffective, or obsolete, or using medical devices that have not been registered by the law.
IV. Refusing to recall after being ordered by the department in charge of drug supervision and management, or refusing to stop the production, import, and operation of medical devices after the department in charge of drug supervision and management orders to stop or suspend production, import, and operation.
V. Entrusting an enterprise that does not meet the conditions specified in these regulations to produce medical devices or not managing the production behavior of the entrusted manufacturer.
VI. Importing expired, invalid, obsolete and other used medical devices.
