What does it mean to file for the second class of medical device business

Since June 1, 2014, if the business is engaged in the operation of Class II medical devices, the operating enterprise shall fill in the record for the operation of Class II medical devices.

form, to the local food and drug administration department of the city divided into districts for the record, and submit the filing materials that meet the requirements of the second class of medical device business filing materials.

The food and drug supervision and administration department of the city divided into districts that receives the medical device business filing materials shall check the completeness of the filing materials on the spot, and if the prescribed conditions are met, it shall be filed and issued with the second class of medical device business filing certificates.

The first x represents the Chinese abbreviation of the province, autonomous region, or municipality directly under the central government where the filing department is located, the second x represents the Chinese abbreviation of the administrative region of the districted city where the filing department is located, the third to sixth x represents the four-digit filing year, and the seventh to tenth x represents the four-digit filing serial number.

In the past, the operation of Class II medical devices required to obtain the "Medical Device Business License" of the drug regulatory department, but after the promulgation of the new regulations, the operation of Class II medical devices only needs to go to the local drug regulatory department for business filing (just give a piece of paper for the record). The business permit process has been simplified and the operating standards have been relaxed.

Class II medical devices need to be registered, according to the "Regulations on the Supervision and Administration of Medical Devices", and then they can be marketed! The operation is managed by the State Food and Drug Administration!

According to the new "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650) and the "Medical Device Business Quality Management Standards", first of all, we must understand that medical devices are divided into three categories: Class I, Class II, Class III. Then the medical device business enterprise is applying for the second-class medical device business record and applying for the third-class medical device business license.

1. The office area is not less than 40 square meters; (business building or storefront);

2. The warehouse area is not less than 15 square meters; (Our company can provide) (three types of refrigerated warehouses containing primary in vitro diagnostic reagents);

3. If there are three types of disposable products, the office address and warehouse area together shall not be less than 160 square meters;

If the warehousing is entrusted to a third-party logistics company, a logistics company with medical device licensing qualifications is required.

4. 1 person with a bachelor's degree or above or intermediate technical title in medical devices, medicine and pharmacy is responsible for quality.

5. 2 with high school degree or above, as a quality administrator;

In 2018, according to the "Regulations on the Supervision and Administration of Medical Devices", all units engaged in the operation of Class II medical devices need to go to the food and drug supervision and administration department of the city divided into districts where they are located for the record. Such as: medical suture needles, blood pressure monitors, thermometers, electrocardiogram machines, electroencephalogram machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, etc.

The following is an answer to the filing requirements for Class II medical devices in 2018.

Filing requirements for Class I and Class II medical devices.

1.80 square meters of commercial office and 60 square meters of warehousing.

medical professionals are in charge of the business.

3.Product management catalog.

Note: If you meet the above 3 points, you can basically apply for the filing of Class II medical devices.

II. Requirements for the filing of Class II medical devices Submission materials.

1.Application for the filing of Class II medical devices.

2.Business license or pre-verification notice.

3.A copy of the identity certificate, academic background or professional title certificate of the legal representative, the person in charge of the enterprise, and the person in charge of quality.

5.Product management directory list.

6.Product Certificate of Conformity.

7.On the purchase and sale contract, purchase channel.

Note: The filing of Class II medical devices is valid for 5 years, and a new certificate for the filing of Class II medical devices shall be renewed to the food and drug supervision and administration department of the city divided into districts where it is located 6 months before expiration.

Legal analysis

Business scope: Class II: 6820 general diagnostic equipment, 6821 medical electronic instruments and equipment, 6822 medical optical instruments, instruments and endoscopic equipment, 6823 medical ultrasound instruments and related equipment, 6824 medical laser instruments and equipment, 6825 medical high-frequency instruments and equipment, 6826 physical ** and ** equipment.

Legal basis

Measures for the Administration of Medical Device Business Enterprise License》 Article 3 The operation of Class II and Class III medical devices shall hold the "Medical Device Business Enterprise License", but a small number of Class II medical devices that can ensure their safety and effectiveness through routine management in the circulation process may not apply for the "Medical Device Business Enterprise License". The list of Class II medical device products that do not need to apply for the "Medical Device Business Enterprise License" shall be formulated by the State Food and Drug Administration.

Criminal Law of the People's Republic of China Article 225 Crime of Illegal Business Operation Violation of state regulations by committing one of the following illegal business operations.

1) Engaging in franchises, monopoly items, or other restricted items as provided for by laws and administrative regulations without permission;

2) Buying and selling import and export licenses, import and export certificates of origin, and other business licenses or approval documents stipulated by laws and administrative regulations;

3) Without the approval of the relevant competent state departments, illegally operating **, ** or insurance business, or illegally engaging in fund settlement business;

4) Engaging in other illegal business activities, disrupting market order, and the circumstances are serious.

Legal analysis: The filing of Class II medical devices is a filing system implemented in 2014, in which enterprises operating Class II medical devices need to file with the local Food and Drug Administration and submit relevant filing materials. Usually we say that the medical devices of the institute mainly include three categories:

The first type is mainly routine management to ensure safe and effective medical devices, which do not need to be recorded. Class II medical devices mainly refer to medical devices that need to be controlled to ensure safety and effectiveness, and need to be filed with the local Food and Drug Administration. For medical devices implanted in the human body, used to support life maintenance and threatening to the human body, and need to be strictly controlled for their safety and effectiveness, they must apply to the Food and Drug Administration for the management of the third class of medical device business licenses.

With the recent epidemic prevention and control work ushered in a critical period, whether it is medical masks, protective clothing, protective eye shields and other medical products have become the key to the safety of front-line medical workers, but whether it is an enterprise or an individual, if you want to operate and sell such medical products, you need to first file with the local Food and Drug Administration for the second class of medical devices, and only after getting the record certificate can you sell related medical products in accordance with the law, if there is a demand for the production of medical products, you need to apply for a third class medical device business license.

Legal basis: Drug Administration Law of the People's Republic of China Article 3 Drug management should be centered on people's health, adhere to the principles of risk management, whole-process control and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.

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It means that since June 1, 2014, if the business is engaged in the operation of Class II medical devices, the operating enterprise shall fill in the Class II medical device business record form, file with the food and drug supervision and administration department of the city divided into districts where it is located, and submit the filing materials that meet the requirements of the Class II medical device business filing materials. First of all, we must understand that medical devices are divided into three categories: Class I, Class II, Class III, at present, the operation of a class of products does not need to apply for a medical device business license, the operation of a class II product is required to handle the class II medical device business record certificate, and the operation of a class III product is to handle the medical device business license.

Do not bury the need. According to the new measures for the supervision and administration of medical device operation, Article 3 "The first class of medical devices does not need to be licensed and recorded; The operation of Class II medical devices shall be subject to record management; The operation of the third type of medical sachet therapy equipment shall be subject to license management. "Therefore, there is no need to file for a class of medical devices that only operate in the local area; The production of Class I medical devices is subject to filing.

Legal basis: Article 5 of the Regulations on the Supervision and Administration of Medical Devices The supervision and management of medical devices follows the principles of risk management, whole-process control, scientific supervision and social co-governance.

Legal analysis1. Consultation or on-site consultation, preparation of application materials;

2. Online declaration and submission of paper materials;

3. The staff accepts it online;

4. On-site survey by staff with poor warehouses;

5. Obtain the second class of medical device business record.

Legal basisMeasures for the Administration of Medical Device Business Enterprise License》 Article 3 The operation of Class II and Class III medical devices shall hold the "Medical Device Business Enterprise License", but a small number of Class II medical devices that can ensure their safety and effectiveness through routine management in the circulation process may not apply for the "Medical Device Business Enterprise License". The list of Class II medical device products that do not need to apply for the "Medical Device Business Enterprise License" shall be formulated by the State Food and Drug Administration.

The above is only the current information combined with my understanding of the law, please refer to it carefully!

If you still have questions about this issue, it is recommended that you discuss the relevant information with a professional in detail.

If it is engaged in the operation of Class II medical devices, the operating enterprise shall fill in the Class II medical device business filing form, file with the food and drug supervision and administration department of the city divided into districts where it is located, and submit the filing materials that meet the requirements of the Class II medical device business filing materials.

At present, Class I does not need to apply for a medical device business license.

Class II needs to apply for Class II medical device business record certificate.

The third category needs to apply for a medical device business license.

Such as: Hechai. This is the record certificate of the medical device manufacturer.

Yadu Medical Device Filing Certificate.

This is a license for medical device manufacturers.

Yadu Medical Device License.