A Maximum Fine of 30 Times! Publication of Punishment Standards for Violations of Medical Devices

On April 8, the Beijing Municipal Food and Drug Administration issues a public announcement on Soliciting Opinions on the Beijing Administrative Punishment Discretion Benchmark for Medical Devices (Exposure Draft) (hereinafter referred to as the Benchmark), announcing detailed punishment discretion for illegal acts in the development, production, operation and use of medical devices.

There are 221 items in the Benchmark (including 5 items in the general provisions), which are divided into two parts: the general provisions and the discretion level of illegal acts. Specifically, it is divided into three basic discretion levels a, B and C according to the social harmfulness.

The Benchmark is the basic discretion file set for various illegal acts, and its corresponding discretion range is the lower limit and upper limit of reduced, lighter, general, heavier and serious punishment according to law.

For example, the operation of class II and class III medical devices without medical device registration certificate belongs to class A of basic discretion:

✔ If the value of the goods is less than 10000 yuan, a fine of not less than 50000 yuan but not more than 150000 yuan shall be imposed;

✔ If the value of goods is more than 10000 yuan, a fine of more than 15 times and less than 30 times the value of goods shall be imposed;

✔ If the circumstances are serious, it shall be ordered 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, and confiscate the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons of the illegal unit during the period of the illegal act, In addition, they shall be fined not less than 30% but not more than 3 times of their income, and shall be prohibited from engaging in the production and operation of medical devices for life.

How can the punishment of law enforcement personnel be more standardized between 50000-150000 yuan and 15-30 times?

The Benchmark stipulates that according to the four different discretionary circumstances of punishment: mitigated, lighter, general and heavier:

✔ If the value of the goods is less than 10,000 yuan, it is divided into “0-50,000 yuan fine”, “50,000 (inclusive) -80,000 yuan fine”, “80,000 (inclusive) – 120,000 yuan (inclusive) fine” “120,000 yuan fine” – 150,000 yuan (inclusive) fine” four basic discretionary levels;

✔ If the circumstances are serious, the basic discretion shall be made according to three different punishments: lighter, general and heavier: for lighter personnel, a fine of more than 30% (inclusive) of the income and 1.1 times of the income; for ordinary personnel, 1.1 times of the income (inclusive) ) to a fine of 2.2 times (inclusive) and above; for heavy duty personnel, a fine of 2.2 times to 3 times (inclusive) of the income earned.

To sum up, it can also be seen that the “Benchmarks” more clarified the name of the illegal act, the basis for punishment, the content of punishment, the order of basic discretion, the benchmark and the level of exercise, so as to refine and quantify the scope of the applicable discretion of each penalty rule.

Source：Haoyisheng

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