What are the conditions for medical device products to be marketed?

To engage in the business of medical devices, the following conditions shall be met:

A) with the scope of business and business scale to adapt to the quality management institutions or quality management personnel, quality management personnel should have the relevant professional qualifications or professional titles recognized by the state;

2) Have a business and storage place that is compatible with the scope and scale of business;

3) With storage conditions suitable for the scope of business and business scale, all entrusted to other medical device business enterprises for storage may not set up a warehouse;

4) Have a quality management system that is compatible with the medical devices operated;

5) Have the ability of professional guidance, technical training and after-sales service suitable for the medical devices operated, or agree to provide technical support by relevant institutions.

Enterprises engaged in the operation of Class III medical devices shall also have a computer information management system that meets the requirements of medical device operation quality management to ensure that the products operated can be traced. Encourage enterprises engaged in the operation of Class I and Class II medical devices to establish a computer information management system that meets the requirements of medical device management quality.

Article 8 If it is engaged in the operation of Class III medical devices, the business enterprise shall apply to the food and drug supervision and administration department of the city divided into districts where it is located, and submit the following information:

1) A copy of the business license and the ** certificate of the organization;

2) 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;

3) Description of the establishment of the organizational structure and department;

4) A description of the scope of business and the mode of operation;

6) Catalogue of operating facilities and equipment;

7) the management quality management system, work procedures and other documents directory;

8) Introduction to the basic situation and function description of the computer information management system;

9) Proof of authorization of the person in charge;

10) Other supporting materials.

Freda is here to help.

Industrial and commercial registration, product design and development, system establishment, innovative product declaration (if involved), registration testing, clinical trials, registration declaration, production license application.

After this set of processes, it is officially put on sale. Medical devices are strictly managed, and every step must be strictly implemented in accordance with regulatory requirements. --Fly speed cro

Legal analysis: According to the provisions of Liang Shu's "Regulations on the Supervision and Administration of Medical Devices", medical devices must be certified before they are put on sale. The specific requirements and procedures shall be formulated and published by the National Medical Products Administration.

Medical devices that are not certified are not allowed to be marketed. Legal basis: Article 12 of the Regulations on the Supervision and Administration of Medical Devices Article 12 The production, operation and use of medical devices shall comply with national laws and regulations, mandatory standards and the requirements of safety, effectiveness, auspicious slag stimulation, energy saving, environmental protection and humanization.

Article 16 Medical device production and business units shall carry out the procedures for filing, licensing, registration, alteration and cancellation in accordance with relevant national regulations. Article 33 Medical device manufacturers shall carefully manage product quality in accordance with regulations, ensure that product quality meets national and industry standards, and ensure that products are safe, effective and reliable. Medical devices that have not been licensed and recorded, have not been evaluated in terms of performance and safety, and have not been inspected and qualified are prohibited from being marketed.

Summary. Medical things before the market of medical devices include:1

Clinical trials: Medical devices need to undergo clinical trials before they are marketed to evaluate their safety and efficacy. These tests need to meet certain scientific standards and ethical requirements to ensure that no harm is caused to the human body during the experiment.

2.Technical evaluation: Medical devices need to undergo technical evaluation before they are marketed, including evaluation of product design, production process, material selection, etc., to ensure that the product meets relevant standards and regulations.

3.Safety evaluation: Medical devices need to conduct safety evaluation before they are marketed, including an assessment of possible risks and the development of corresponding measures to reduce risks.

Medical things before the market of medical devices include:1Clinical Trials:

Medical devices require clinical trials to evaluate their safety and efficacy before they are marketed. These tests need to meet certain scientific standards and ethical requirements to ensure that there is no damage to the garter during the test. 2.

Technical evaluation: Medical devices need to undergo technical evaluation before they are marketed, including evaluation of product design, production process, material selection, etc., to ensure that the product meets relevant standards and regulations. 3.

Safety evaluation: Before the marketing of Nianhaowu medical devices, it is necessary to conduct a safety evaluation of the liquidity, including the assessment of possible risks, and formulate corresponding measures to reduce the risks.

4.Efficacy evaluation: Before the medical device is marketed in the state, it is necessary to conduct an efficacy evaluation book to determine whether the product has the expected effect and compare it with other similar products.

6.Regulatory review: Medical devices also need to be subject to regulatory review and supervision after marketing to ensure the quality and safety of the product.

Summary. Hello, the medical things before the market of medical devices have the following aspects:1

Medical device R&D: The R&D process requires clinical trials and basic research to verify the safety and efficacy of the device, as well as determine its scope of application and operation methods. 2.

Clinical trials: In clinical trials, medical devices need to go through multiple clinical trial phases to prove their safety and efficacy. These trials must comply with ethical and legal requirements and be conducted in an independent institution.

Complete clinical trial data is required during the approval process to demonstrate that the medical device meets safety and efficacy requirements. <>

Hello, the medical things before the market of medical devices have the following aspects:1Medical device R&D:

The R&D process requires clinical trials and basic research to verify the safety and efficacy of the device, as well as to determine its scope of application and operation methods. 2.Clinical Trials:

In clinical trials, medical devices need to go through multiple clinical trial phases to prove their safety and efficacy. These trials must comply with ethical and legal requirements and be conducted in an independent institution. 3.

Approval: Medical devices need to be approved by relevant authorities before they are marketed, such as the US FDA, the EU CE certification, etc. Complete clinical trial data needs to be provided during the approval process to demonstrate that the medical device meets safety and efficacy requirements.

4.Device markings and labels: Device markings and labels should include information such as the device's name, model, scope of application, operation methods, warnings, and precautions to ensure that users use the device correctly.

5.Technical documentation and quality management: Before the medical device is launched, it is necessary to prepare the complete technical documentation of Chunzhenkai, including the design, manufacturing, testing, maintenance and other information of the equipment.

At the same time, equipment manufacturers need to establish a strict quality management system to ensure the quality and reliability of equipment. 6.Market Regulation:

After the medical device is marketed, it needs to be subject to market supervision, including production process supervision, equipment quality supervision, clinical effect supervision, etc., to ensure the safety and effectiveness of the device. <>

1. The production license is a necessary certificate for the production of medical devices.

2. If the product produced belongs to a class of medical devices, the product needs to be recorded. After obtaining the record certificate, it can be produced after being included in the scope of the production license. The products produced by themselves can be sold by themselves without business filing or licensing.

If you sell products produced by others that are not your own company registration certificate, you need to determine whether you need to apply for a business license or a class of business filing according to the category of products sold by Tongla.

3. The registration certificate or filing certificate of the product is the first step of sales and listing, and it cannot be sold without getting it.

To sum up, you must first get a registration certificate or filing certificate. Then it depends on whether you can produce jujube by yourself or entrust others to produce it. Self-production needs to apply for a production license, and then the products registered and filed by the bureau are included in the production license list. It can be produced and put on sale.

If you entrust others to produce, you need to find the entrusting party and go through the relevant procedures for consignment production. Included in the list of production licenses of the contractor. It can be produced and put on sale.

Quality, performance, service life, after-sales service, aesthetics, market demand.

It has not obtained overseas marketing authorization.

Information to be submitted for the first registration of Class II and III medical devices: 1. Application form for registration of overseas medical devices; 2. Qualification certificate of medical device manufacturer; 3. A copy of the applicant's business license and a power of attorney for ** registration granted by the manufacturer; 4. Product technical report; 5. Security risk analysis report; 6. Applicable product standards and descriptions (two copies); 7. Product performance self-test report; 8. Product registration test report issued by medical device testing institutions; 9. Clinical trial data of medical devices; 10. Medical device instructions; 11. Valid certification documents for product production quality system assessment (certification); 12. The power of attorney, the letter of commitment and the business license or the registration certificate of the enterprise designated by the manufacturer in China; 13. Power of attorney of the designated after-sales service organization in China, letter of commitment and qualification certificate of the entrusted organization; 14. A self-assurance statement on the authenticity of the submitted materials. Aoshida sincerely answers for you...

The following information** is on the official website of Freda Medical Advisory.

1. Project name: registration of domestic medical devices.

2. License content: the first registration of Class III medical devices in China.

3. Legal Basis for Establishing and Implementing Licenses:

Articles 8 and 12 of the Regulations on the Supervision and Administration of Medical Devices, and the Administrative Measures for the Registration of Medical Devices

4. Charges: No charges.

5. Quantity limit: There is no limit on the number of items in this license.

6. List of materials submitted by the applicant:

Data No. 1, Application Form for Registration of Domestic Medical Devices;

Data No. 2, medical device manufacturer qualification certificate;

Data No. 3, Product Technical Report;

Data No. 4, Security Risk Analysis Report;

Data No. 5, applicable product standards and descriptions (2 copies);

Data No. 6, product performance self-test report;

Data No. 7, product registration test report issued by medical device testing institutions;

Data No. 8, medical device clinical trial data;

Data No. 9, medical device instructions;

Data No. 10, effective certification documents for product production quality system assessment (certification) - according to the requirements of different products, provide corresponding quality system assessment reports;

Document number 11, a self-assurance statement of the authenticity of the submitted materials.

7. Requirements for application materials:

1) General requirements for application materials:

1. The first page of the application materials is the catalog of application materials, and the items in the application materials are arranged in the order of Annex 3 of the Administrative Measures for the Registration of Medical Devices. Each information is covered with a cover page, and the product name and the applicant's name are indicated on the cover page, and the name of the information is indicated in the upper right corner. Conspicuous distinguishing marks shall be used between the various materials, and the name of each information or the serial number in the directory in which the information is located shall be indicated.

The complete set of materials should be bound into a book.

2. The application materials shall be in duplicate, and the application materials shall be printed on A4 size paper, and the content shall be complete, clear and shall not be altered.

I don't understand this, so it's not okay to do it.