Distress! Some specific requirements for the filing of new Class II medical devices

1.Class II medical device business record form 2Copy of business license of the enterprise 3

A copy of the identity, education, and title certificate of the legal representative or person in charge of the enterprise and the person in charge of quality4Description of the organization and department of the enterprise. If you want to know more details, it is recommended to consult Guangzhou Gehui Taifu Biotechnology****.

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.

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 must 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.

2. There are requirements for the filing personnel of the second class of medical device business:

1. One person with a bachelor's degree or above or intermediate technical title in medical devices, medicine, pharmacy as the person in charge of quality;

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

3. There are requirements for the filing materials for the operation of Class II medical devices:

1. Application**;

2. A copy of the business license of the enterprise;

3. Certificate of identity, education or professional title of the legal representative or person in charge of the enterprise and the person in charge of quality;

4. The geographical location map and floor plan of the business site and warehouse address of the enterprise; (indicate the actual use of the site);

5. Commercial real estate certificate and red book lease contract or site use certificate;

6. Catalogue of operating facilities and equipment;

7. Catalogue of enterprise operation quality management system, work procedures and other files;

8. Other supporting materials (provided by our company).

Extended Information: Class II Medical Devices.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray machine, B-ultrasound, microscope, biochemical instrument, etc., all belong to the second class of medical devices. According to Article 30 of Chapter IV of the Regulations on the Supervision and Administration of Medical Devices [2].

If it is engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the people's government at the municipal level divided into districts where it is located and submit the certification materials that it meets the conditions specified in Article 29 of these Regulations. (Article 29 engaged in medical device business activities, there shall be a business site and storage conditions suitable for the scale and scope of business, as well as a quality management system and quality management institutions or personnel suitable for the medical devices operated.) )

1.The business license of the company type shall be obtained in accordance with the law, and its business scope includes the distribution of medical devices, and individual industrial and commercial households cannot apply for a medical device business license or filing. 2.

Have a quality management organization or quality management personnel suitable for the scope and scale of business, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state. Among them: (1) the person in charge of the quality of the medical device business enterprise shall have a college degree or above or an intermediate professional title or above in medical device related majors (related majors refer to medical devices, biomedical engineering, machinery, electronics, medicine, biological engineering, chemistry, pharmacy, nursing, laboratory science, computer, law, management, etc.), and shall have more than 3 years of medical device business quality management experience.

2) Among the quality management personnel engaged in in in vitro diagnostic reagents, one person should be the competent inspector, or have a college degree or above in laboratory science related majors and have more than 3 years of work experience in testing-related work. Personnel engaged in the acceptance and after-sales service of in vitro diagnostic reagents shall have a technical secondary school degree or above in a laboratory related major or have a professional and technical title of a primary or above inspector. (3) Among the personnel engaged in the operation of implantable and interventional medical devices, they shall be equipped with medical-related personnel.

Professional college degree or above, and through the production enterprise or business training personnel. (4) Personnel engaged in the operation of other medical devices with special requirements such as contact lenses and hearing aids shall be equipped with personnel with relevant professional or professional qualifications.

The requirements of the person in charge of quality in medical devices can be based on the provisions of Chapter III of the "Medical Device Business Quality Management Standards" as follows: Article 10 The legal representative, person in charge and quality management personnel of the enterprise shall be familiar with the laws, regulations, rules and regulations of medical device supervision and management and the relevant knowledge of the medical devices operated, and meet the qualification requirements of the relevant laws and regulations and this specification, and shall not be prohibited by relevant laws and regulations. Article 11 The enterprise shall have a quality management organization or quality management personnel suitable for the scope and scale of business, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state.

Thank you for the trouble and give it a thumbs up!

1. Have two quality management institutions or quality management personnel with college degree or above that are suitable for the scale and scope of business. Quality management personnel shall have relevant professional qualifications or professional titles;

2. Have a relatively independent business place that is suitable for the scale and scope of business;

3. Have storage conditions suitable for the scale and scope of business, including storage facilities and equipment that meet the characteristics requirements of medical device products;

4. Establish and improve the product quality management system, including procurement, purchase acceptance, warehousing and storage, outbound review, quality tracking system and adverse event reporting system;

5. It shall have the ability of technical training and after-sales service suitable for the medical device products it operates, or agree to provide technical support by a third party.

[Legal Analysis]: The operation of Class II and Class III medical devices shall hold 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.

Enterprises operating medical device products need to apply for a "Medical Device Business Enterprise License" from the local Food and Drug Administration. 1. Materials required for the registration of medical device companies: 1. The name and business scope of the enterprise, the registered capital and the proportion of shareholders' capital contribution, and the identity certificates of shareholders; 2. Medical device product registration certificate, manufacturer license, business license and authorization letter; 3. Quality management documents and other medical professional or related professional certificates, identity certificates and resumes.

Those who fail to apply for the "Medical Device Business Enterprise License" will be punished accordingly by the State Food and Drug Administration.

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 can 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.

[Legal Analysis].1. 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 basis].Article 3 of the 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.

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.

Class II filing process for medical devices:

1.Enter the second-class medical device service platform of the Market Supervision Bureau to view all the handling details.

2.If you use the legal entity login, you can only do it if you are linked to the company information.

3.After passing the review, the second-class medical record certificate can be issued, and you can print it out by yourself.

Article 3 of the Measures for the Supervision and Administration of Medical Device Business.

The State Food and Drug Administration is responsible for the supervision and management of medical device operation nationwide. The food and drug supervision and administration department at or above the county level is responsible for the supervision and management of medical device operation in the administrative region.

The higher-level food and drug supervision and administration department is responsible for guiding and supervising the lower-level food and drug supervision and administration departments to carry out the supervision and management of medical device operation. Laugh at the potatoes.

Article 4. According to the degree of risk of medical devices, the operation of medical devices implements classified management.

The operation of Class I medical devices does not require licensing and filing, the operation of Class II medical devices is subject to record management, and the operation of Class III medical devices is subject to license management.