Medical equipment supervision | These behaviors will be severely punished!

Recently, the Comprehensive Department of the NMPA publicly solicited opinions on the “Rules for the Application of Discretion in Administrative Penalties in Drug Supervision and Administration (Exposure Draft)”.

This rule contains six chapters, including general rules, discretionary circumstances, discretionary procedures, discretionary benchmarks, discretionary supervision, and supplementary rules. Among them, in the discretionary circumstances chapter 9, 10 mentioned the following severe punishment circumstances:

Circumstances of heavier punishment

Article 9 :(should be given a heavier punishment) If the party has any of the following circumstances, it shall be given a heavier punishment according to law:

(1) Passing off narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, precursor chemicals of pharmaceutical class, or injections as other drugs, or passing off other drugs as the above-mentioned drugs;

(2) producing, selling or using fake or substandard drugs that are mainly used by pregnant women, children and critically ill patients, medical devices that do not meet mandatory standards or technical requirements of products that have been registered and filed, or cosmetics that do not meet mandatory national standards, technical specifications or technical requirements set forth in the registration and filing materials of cosmetics;

（3） The biological products produced, sold, or used belong to counterfeit or substandard drugs;

4)Producing, selling or using counterfeit or substandard drugs, medical devices that do not meet mandatory standards or technical requirements for products registered and filed, or cosmetics that do not meet mandatory national standards or technical specifications, resulting in personal injury or other serious harmful consequences;

(5) Producing, selling or using counterfeit or substandard drugs, and recommitting the offence after treatment; Producing, selling or using medical devices that do not meet the mandatory standards or the technical requirements of the products registered for the record, or producing and marketing cosmetics that do not meet the mandatory national standards, technical specifications or the technical requirements set forth in the registration and record of cosmetics, and committing another offense within three years after treatment;

(6) When natural disasters, accidents, public health events, social security events and other emergencies occur, the production, sale or use of drugs used in response to emergencies are counterfeit or substandard drugs, or the medical devices used in response to emergencies do not meet the mandatory standards or do not meet the technical requirements of products registered and filed;

(7) Having received criminal punishment for illegal acts;

（8） Other severe punishment situations stipulated by laws, regulations, and rules.

Article 10: (can be given a heavier punishment) If the party has one of the following circumstances, it may be given a heavier administrative penalty according to law:

(1) The products involved in the case are high-risk products, except for the circumstances in paragraph 1 (2) of Article 9;

※ Note: For high-risk products, Article 7 of these Rules refers to “implanted devices” as high-risk products

(2) The drug test sterility, pyrogen (such as bacterial endotoxin), microbial limits, antihypertensive substances unqualified, or the drug active ingredient content unqualified, enough to affect the efficacy;

(3) Medical device test sterility, pyrogen, microbial limit, ethylene oxide residue, dielectric strength at normal operating temperature, continuous leakage current at normal operating temperature, protective grounding impedance and other items that are sufficient to affect safety are not qualified;

(4) Producing or marketing drugs, medical devices, cosmetics without registration or filing, or engaging in production or marketing activities without permission, and the products involved are of high risk;

(5) Inciting, coercing or inducing others to commit illegal acts;

(6) Knowingly selling or using illegal products;

(7) Receiving administrative punishment for an illegal act of the same nature within one year;

(8) Committing an illegal act more than three times within two years or the illegal act lasts for six months or more;

(9) refusing or evading supervision and inspection, forging, destroying or concealing relevant evidentiary materials, or unauthorized use of sealed, seized or pre-registered and stored articles;

(10) Obstructing or refusing to cooperate with administrative law enforcement personnel in performing their duties according to law, or retaliating against administrative law enforcement personnel, informants, witnesses or expert witnesses;

（11） Those who are ordered by the drug regulatory department to stop or rectify their illegal behavior within a specified time limit in accordance with the law, and continue to carry out their illegal behavior, unless there are other provisions in laws, regulations, and rules regarding the refusal to correct the order;

(12) Other cases that may be subject to heavier administrative penalties.

If the circumstances specified in item (9) of the first paragraph of this article require separate punishment or heavier punishment according to laws, regulations, or rules, the provisions shall prevail. If the party involved has been subjected to administrative punishment for the act referred to in item (10) of the preceding paragraph, the act shall no longer be regarded as a heavier administrative punishment. If the same illegal act simultaneously meets the conditions specified in items (9) and (10), item (9) shall prevail. The starting point of time shall be calculated from the date of the end of the last illegal act.

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Translated & edited ： Bradyknow