These companies suffered when conditions for manufacturing medical devices changed without corrective measures being taken
Under the background of the reform and upgrading of the medical system, the problem of compliance management in the production/management of medical devices has become increasingly prominent. In the process of dynamic inspection, the focus of the supervision of the drug regulatory department on the enterprise will penetrate into all links of the life cycle, strengthen the supervision during and after the event, NMPA establishes a team of full-time inspectors to carry out daily follow-up inspection of the enterprise, and “flight inspection” has become the norm.
Ⅰ. The production conditions of medical devices have changed but no rectification measures have been taken
A medical device Co., Ltd. in Tianjin produced disposable medical protective clothing and disposable surgical clothing when the air conditioning purification system was not opened in the clean workshop. It was still used for microbial index and sterility test after the constant temperature incubator in the gas chromometer and test room was damaged. Failure to rectify the above changes in production conditions, stop production and report to Tianjin Drug Administration.
Treatment measure
（1）A fine of 30,000 yuan
（2）Basis of punishment
Item (1) Paragraph 1, Article 88 of the Regulations on the Supervision and Administration of Medical Devices: “Under any of the following circumstances, the department in charge of drug supervision and administration shall order correction and impose a fine of not less than 10000 yuan but not more than 50000 yuan; if it refuses to correct, it shall impose a fine of not less than 50000 yuan but not more than 100000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business, until the original license issuing department revokes the production license and business license of medical devices, and the legal representative, main person in charge, directly responsible person in charge and other responsibilities of the illegal unit Personnel shall be confiscated of their income from the unit during the period when the violation occurred, and a fine of more than 30% but less than 2 times of their income shall be imposed. They shall be prohibited from engaging in the production and operation of medical devices within 5 years: (I) The production conditions have changed, no longer meet the requirements of the medical device quality management system, and they have not rectified, stopped production and reported in accordance with the provisions of these Regulations; ”
Ⅱ . The production quality management system fails to maintain effective operation
The quality management system of a denture limited company in Liaoyang failed to maintain effective operation, and some customized fixed dentures were delivered for sale without inspection, and there were no production records, finished product inspection records and product release records.
Treatment measure
（1）A fine of 30,000 yuan.
（2）Basis of punishment
Item (2) of Article 86 of the Regulations on the Supervision and Administration of Medical Devices: “Under any of the following circumstances, the department responsible for drug supervision and administration shall order correction and confiscate the medical devices used in illegal production and operation;”; If the value of medical instruments used in illegal production and operation is less than 10000 yuan, a fine of more than 20000 yuan but less than 50000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of not less than 5 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business until the original license-issuing department revocation the registration certificate of medical devices, the production license of medical devices and the business license of medical devices. The legal representative, the principal person in charge, the person in charge directly responsible and other responsible personnel of the illegal unit shall be confiscated the income earned from the unit during the period when the illegal act occurs. He shall be fined not less than 30% but not more than 3 times his income, and shall be prohibited from engaging in the production and operation of medical devices within 10 years: (1) Producing, marketing or using medical devices that do not meet mandatory standards or do not meet the technical requirements for products registered or filed; (2) failing to organize production in accordance with the registered or filed product technical requirements, or failing to establish a quality management system and maintain its effective operation in accordance with the provisions of these regulations, affecting the safety and effectiveness of products; …”
Ⅲ. Producing medical devices that do not meet mandatory standards
A medical equipment company in Henan Province produced medical surgical masks that did not meet mandatory standards, and the mask belt did not meet the requirements.
Treatment measure
（1）A fine of 30,000 yuan.
（2）Basis of punishment
Item (1), Paragraph 1, Article 86 of the Regulations on the Supervision and Administration of Medical Devices (Revised 2021 Edition) : “In any of the following cases, the department responsible for drug supervision and administration shall order it to make corrections and confiscate the medical devices used in illegal production or marketing; If the value of medical devices used in illegal production or business is less than 10,000 yuan, a fine of between 20,000 yuan and 50,000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of not less than 5 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business until the original license-issuing department revocation the registration certificate of medical devices, the production license of medical devices and the business license of medical devices. The legal representative, the principal person in charge, the person in charge directly responsible and other responsible personnel of the illegal unit shall be confiscated the income earned from the unit during the period when the illegal act occurs. He shall be fined not less than 30% but not more than 3 times his income, and shall be prohibited from engaging in the production and operation of medical devices within 10 years:
Ⅳ. Production of medical devices that do not meet the registered or filed product technical requirements
A medical instrument company in Suqian produced surgical scissors that did not meet the technical requirements of the recorded products.
Treatment measure
- 117 unqualified surgical scissors were confiscated;
- A fine of 20,000 yuan.
- Basis of punishment
（1）Item (1) of Article 66, Paragraph 1 of the Measures for Supervision and Administration of Medical Device Production (revised in 2017) : “Any of the following circumstances shall be punished according to Article 66 of the Regulations on the Supervision and Administration of Medical Devices:
（2） Item (1) of Article 86, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices.
The disposable medical masks produced by a sanitary material Co., Ltd. in Anhui do not meet the requirements, and the microbial indicators do not meet the requirements.
Treatment measure
（1）The fine is 45,000 yuan.
（2）Basis of pubnishment
Item (1) of Article 86, Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
By An Explorer of Medical Compliance
Translated & edited | Bradyknows
