Chapter V Legal Liabilities

Article 65 For illegal acts in medical device distribution, there have been provisions prescribed in the Regulations on Supervision and Administration of Medical Devices and other laws and regulations, and such provisions shall prevail.

Article 66 For any of the following circumstances, rectification shall be ordered within prescribed time limit, and a fine of not less than 10,000 yuan and not more than 50,000 yuan shall be imposed; for serious circumstances, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed; and for hazardous consequences, a fine of not less than 100,000 yuan and not more than 200,000 yuan shall be imposed:

(1) Class III medical device distributors change their distribution premises, distribution scope, distribution mode and warehouse address arbitrarily;

(2) Upon expiration of valid term of the Medical Device Distribution License, the distributor continues to engage in distribution activities of medical devices without handling renewal formalities according to law.

For entities engaging in distribution activities of Class III medical devices without license, punishment shall be imposed as stipulated in Article 81 of the Regulations on Supervision and Administration of Medical Devices.

Article 67 For violation of relevant requirements in the Good Supply Practice for medical devices, the drug regulatory departments shall order rectification within prescribed time limit; if safety and effectiveness of medical device products are influenced, punishment shall be imposed as stipulated in Article 86 of the Regulations on Supervision and Administration of Medical Devices.

Article 68 If medical device distributors fail to submit annual self-inspection report of quality management system as required, or provide storage and transportation services specifically for other medical device manufacturers and distributors in violation of these Provisions, the drug regulatory departments shall order rectification within prescribed time limit; for refusal to rectification, a fine of not less than 10,000 yuan and not more than 50,000 yuan shall be imposed; for serious circumstances, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed.

Article 69 If Class III medical device distributors fail to handle change in enterprise name and person in charge of the enterprise as stipulated in these Provisions, the drug regulatory departments shall order rectification within prescribed time limit; for refusal to rectification, a fine of not less than 5,000 yuan and not more than 30,000 yuan shall be imposed.

Article 70 Personnel of the drug regulatory departments that abuse their powers, neglect their duties, engage in malpractice for personal gains in violation of these Provisions shall receive disciplinary punishment according to law.

Chapter VI Supplementary Provisions

Article 71 As used in these Provisions:

Wholesale of medical devices means the medical device distribution act of selling the medical devices to medical device manufacturers, medical device distributors, medical device using units or other units with reasonable use demands.

Retail of medical devices means the medical device distribution act of selling the medical devices to individual consumers for use directly.

Article 72 To engage in online sales of medical devices, an entity shall abide by relevant stipulations of laws, regulations, and provisions.

Article 73 These Provisions shall come into force as of May 1, 2022. Upon effectiveness of these Provisions, the Provisions for Supervision and Administration of Medical Device Distribution issued by Decree No. 8 of the former China Food and Drug Administration on July 30, 2014 shall be abolished.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.