Whether the plaster can be advertised as a medical device

Machinery products belong to the category of medical devices, that is, they can also be simply understood as device products, mainly for external use, and the main effect is external auxiliary**. It also has its fixing effect. They are generally categorized inherently, and the intended use is explained in a simple manner.

In theory, medical device products can only promote their intended use, and cannot vigorously promote the effects other than the intended use or add the efficacy that is not in the intended use, nor can they promote any treatment and ** These sensitive words.

Another point is that when promoting medical device products, it can only display its organization and its composition, and cannot display the specific drug names and specific product names on the packaging and instructions like drugs, cosmetics and health care products.

The barrier to entry for selling medical devices is not as high as that for pharmaceuticals and healthcare products. Medical devices are divided into Class I, Class II, and Class III. Individuals, individual industry and commerce, general taxpayers, etc. can sell a class of medical device products normally, without a franchise license, as long as the manufacturer has a relevant record.

Like what we often come into contact with at home: band-aids, absorbent cotton balls, disposable medical masks, medical shoe covers, foot covers, liquid dressings, liquid sprays, medical cold compresses, antipyretic patches in medical beauty products** (I heard a product development say before, if medical beauty products are for mass consumption, they will basically purchase the approval documents of a class of products, which is convenient for the production of distributors and does not require a special franchise license), etc.

To operate Class II medical devices, it is necessary to apply for Class II business record certificate and relevant categories corresponding to the business license, otherwise it is illegal to sell, and Class III medical devices also need the corresponding franchise license.

Legal analysis: ordinary plasters belong to the first class of medical devices, but there are also class II medical devices, whether they are legal depends on the type of plaster sold.

Legal basis: Article 81 of the Regulations on the Supervision and Administration of Medical Devices In any of the following circumstances, the department responsible for drug supervision and administration shall confiscate the illegal gains, medical devices used in illegal production and operation, and tools, equipment, raw materials and other items used in illegal production and operation; If the value of medical devices illegally produced and operated is less than 10,000 yuan, a fine of between 50,000 yuan and 150,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of between 15 and 30 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business, and shall not accept the application for medical device license submitted by the relevant responsible person and unit within 10 years, and confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income obtained, and prohibit it from engaging in medical device production and business activities for life

1) Production and operation of Class II and Class III medical devices that have not obtained medical device registration certificates;

2) Engaging in Class II and Class III medical device production activities without permission;

3) Engaging in Class III medical device business activities without permission.

In the circumstances of item 1 of the preceding paragraph and the circumstances are serious, the original licensing department shall revoke the medical device production license or medical device business license.

Summary. Legal basis: Article 41 of the "Yao Product Administration Law of the People's Republic of China" shall be approved by the people's drug regulatory department of the province, autonomous region and municipality directly under the Central Government to obtain a drug production license.

Without a drug production license, no drug shall be produced. The drug production license shall indicate the validity period and scope of production, and shall be re-examined and issued upon expiration. TCM polyclinics can sell plasters, but they can't be placed in the medicine cabinet, they can be placed in the medicine counter.

If you want to sell plasters, it is not illegal, you must have the relevant qualifications required by law, and have the qualification for drug production. Establish a pharmaceutical business enterprise in accordance with the law.

Hello dear, happy to answer your <>

It's illegal to sell plasters.

Legal analysis: It is illegal to sell plasters with a machine name, and it is illegal for individuals to sell plasters, but it is not necessarily a crime. The production and sale of the plaster shall obtain the corresponding license before it can be carried out.

Otherwise, it is an illegal act of unlicensed production or operation without a license, and the perpetrator shall be punished accordingly.

Legal basis: Article 41 of the "Yao Product Management Law of the People's Republic of China" to engage in drug production activities shall be approved by the people's drug supervision and management department of the province, autonomous region and municipality directly under the Central Government, and obtain a drug production license. Without a drug production license, no drug shall be produced.

The drug production license shall be marked with the validity period and production scope of the drug production license, and the license shall be re-examined and issued upon expiration. TCM polyclinics can sell plasters, but they can't be placed in the medicine cabinet, they can be placed in the medicine counter. If you want to sell plasters, you must have the qualifications required by law to have drug production qualifications and other qualifications.

Establish a pharmaceutical business enterprise in accordance with the law.

All plaster plaster registration number format is "(1 (food) drug administration (2) word 3, 4, 5, 6" belongs to the plaster number.

Among them, 1 is the abbreviation of the location of the registration and approval department

Domestic Class III medical devices, overseas medical devices and medical devices in Taiwan, Hong Kong and Macao are"country"Word.

The second class of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the registration and approval department is located.

The abbreviation of the province, autonomous region and municipality directly under the central government where the registration and approval department is located plus the abbreviation of the districted municipal administrative area where the registration and approval department is located is 1 (when there is no corresponding districted municipal administrative region, it is only the abbreviation of the province, autonomous region and municipality directly under the central government).

Due to plasters, ointments, and gels, most of them have ** and auxiliary ** effects. Therefore, it depends on two aspects, on the one hand, whether the product is more in line with the drug or the medical device, and on the other hand, which is more convenient for the manufacturer to apply. 9389

Can Shandong Zhu's Pharmaceutical Group Centennial Huahan Plaster be sold in hospitals and pharmacies?

Qingbeetang muscles and bones pass through medical cold compresses.