Interpretation of the Policy of Beijing Medical Device Administrative Punishment Discretion Benchmark
2022-06-27
I. What is the basis and main changes of the revision of Beijing Medical Device Administrative Punishment Discretion Benchmark?
In order to strictly and uniformly regulate the application of administrative penalty discretion of law enforcement personnel in the field of medical devices in Beijing, in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Operation, the Measures for the Supervision and Administration of medical device production, the Measures for the Registration and Filing of In Vitro Diagnostic Reagents, and the Measures for the Registration and Filing of Medical Devices, and in combination with the actual situation of medical device supervision in Beijing, Beijing MPA has dynamically adjusted and revised the Beijing Administrative Punishment Discretion Benchmark for Medical Device Supervision (Trial) (hereinafter referred to as the Old Benchmark) issued in July, 2020, forming the Beijing Administrative Punishment Discretion Benchmark for Medical Devices. The new Benchmark has a total of 222 articles, and stipulates discretion and other related content for the legal liability clauses in the regulations and rules one by one.
II、 How does the Benchmark divide the punishment discretion range?
The Benchmark divides the administrative penalty clauses in the current effective regulations and rules in the medical device field into a basic discretionary order according to the discretionary circumstances of mitigation, lighter, general and heavier, and the amount of fines, personal fines and other types of penalties with a range.
III. What are the principles in the Benchmark for the classification of relevant punishment types and ranges and the order of discretion?
i. For mitigation of punishment, the category or range of punishment below the minimum of legal administrative punishment shall be applied.
ii. For a lighter punishment, a lighter or less punishment type or a lower punishment range shall be applied within the punishment types and ranges that can be selected according to law. The amount of the fine shall be the lower 30% of the range from the minimum to the maximum.
iii. General punishment shall be imposed according to law within the medium range of the statutory punishment.
iv. For heavier punishments, the heavier and more types of punishments or the higher range of punishments shall be applied within the types and ranges of punishments that can be selected according to law. Among them, the amount of the fine shall be the higher 30% of the range from the minimum to the maximum.
IV. How to specifically divide the discretion order of the fine amount in the Benchmark?
If the penalty only stipulates the amount of fine, take the first paragraph of Article 98 of the Regulations on the Supervision and Administration of Medical Devices as an example: “according to the four different penalty discretion circumstances of mitigation, lighter, general and heavier, it is divided into four basic discretion levels:” fine of RMB 0-50000 “,” fine of RMB 50000 (inclusive) -65000 “,” fine of RMB 65000 (inclusive) -85000 (inclusive) “and” fine of RMB 85000-100000 (inclusive) “; If the circumstances are serious, it shall be divided into three basic discretion levels, i.e. “fine of 100000 yuan (inclusive) -220000 yuan”, “fine of 220000 yuan (inclusive) -380000 yuan (inclusive)” and “fine of 380000 Yuan -500000 yuan (inclusive)” according to the three different discretion circumstances of lighter, general and heavier punishment.
V. In the Benchmark, how to specifically divide the discretion order of punishment for the legal representative or main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible persons?
Takeing the punishment for the production and operation of class II and class III medical devices that have not obtained the medical device registration certificate as an example: those who violate the provisions of Article 32, paragraph 1, of the Regulations on the Supervision and Administration of Medical Devices and article 10, paragraph 1, of the Measures for the Supervision and Administration of the Production of Medical Devices, in accordance with the provisions of Article 81, paragraph 1, paragraph 1, and paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices, and the circumstances are serious, order to stop production or business, the original license issuing department shall revoke the production license or business license of medical devices, refuse to accept the application for medical device license submitted by the relevant responsible person and the unit within 10 years, confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit, and impose a fine of not less than 30% but not more than 3 times the income obtained during the period of the illegal act, It is forbidden to engage in the production and operation of medical devices for life.
If the circumstances are serious, it shall be divided into three basic discretion levels according to three different punishment discretion circumstances: lighter: a fine of more than 30% (inclusive) but less than 1.1 times the income of the premises; general: a fine of more than 1.1 times (inclusive) but less than 2.2 times (inclusive) of the income of the premises; heavier: a fine of more than 2.2 times but less than 3 times (inclusive) of the income of the premises.
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