A Class of Medical Device Registration Process

Question 1: What is the registration process of a class of medical devices? Procedures for Registration and Approval of Class I Medical Devices in China

The first class medical device registration (re-registration) in China consists of acceptance and administrative examination and approval. The total time limit for examination and approval is within 30 working days from the date of issuing the acceptance notice.

I. Acceptance

Mainly to review the application materials for the registration (re-registration) of the first class medical devices in China, to ensure the integrity and standardization of the application materials, and to announce the acceptance to the public.

Medical device manufacturers applying for registration (re-registration) of Class I medical devices in China shall submit the required registration application materials to the local food and drug supervision and administration department.

(1) Acceptance requirements

1. Application Form for Registration of Domestic Medical Devices

The Application Form for Registration of Domestic Medical Devices filled in by the applicant enterprise shall be signed by the legal representative and stamped with the official seal. The items filled in shall be complete and accurate, and the contents filled in shall meet the following requirements:

(1) The name and registered address of the production enterprise are the same as the industrial and commercial business license;

(2) "Product name" and "specifications and models" are consistent with the names, specifications and models used in the application materials such as product standards and test reports submitted.

2. Qualification certificate of medical device manufacturing enterprise

The qualification certificate includes a copy of the Registration Form of Class I Medical Device Manufacturers and a copy of the Industrial and Commercial Business License.

(1) The products applied for registration (re-registration) shall be within the production range approved by the Registration Form of Class I Medical Device Manufacturers;

(2) The industrial and commercial business license is within the validity period.

3. Applicable product standards and descriptions

The product standards submitted by the applicant enterprise can be national standards, industry standards or registered product standards.

(1) Where a national standard or an industry standard is adopted as a product standard, an effective text of the adopted national standard or industry standard and an explanation of the adoption shall be submitted;

(2) If the registered product standard is adopted as the product standard, the official text of the registered product standard and its compilation instructions shall be submitted.

4. Product full performance test report

The product full performance test report shall include the following contents:

(1) product name, specification, product number or batch number, production date, sample number and sampling base;

(2) Test basis, test items, standard requirements, test results, result judgment, signatures or seals of inspectors and auditors, test date, etc. ;

(3) If the inspection is entrusted, the inspection report and the entrusted inspection agreement issued by the entrusted inspection institution shall be provided.

5. Description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise.

The description of the existing resource conditions and quality management capabilities (including testing methods) of enterprise products shall include the following contents:

(1) Description of existing resources (human resources, infrastructure, working environment, etc. ), the management ability, production capacity, inspection means and ability of the applicant enterprise;

(2) Provide a list of valid verification certificates (copies) of production equipment, testing instruments and measuring instruments required for product inspection.

6. Instructions for medical devices

Instructions for medical devices shall at least include the following contents:

(1) product name, model and specification;

(2) The name, registered address, production address and contact information of the production enterprise;

(3) The license number, medical device registration certificate number (blank at the time of declaration) and serial number of the medical device manufacturer. Product standards;

(4) Performance, main structure and application scope of the product.

7. Product quality tracking report (chickens are used for re-registration)

The product quality tracking report shall include the following contents:

(1) Description of enterprise product quality control measures and internal audit product quality review;

(2) Feedback from users on product quality during product use;

(3) Regular inspection and daily ex-factory inspection of product quality; Product quality supervision and sampling inspection by the (food) drug supervision and administration department at or above the provincial level;

(4) The enterprise implements the adverse event monitoring system and adverse event monitoring;

(5) Product quality information, statistical analysis, measures taken and verification collected by the enterprise.

8. Original medical device registration certificate (applicable to re-registration)

(1) In case of Article 33 in Chapter 5 of the Measures for the Administration of Medical Device Registration, a copy of the original medical device registration certificate shall be submitted;

(2) In case of Article 34 and Article 35 of Chapter 5 of the Administrative Measures for the Registration of Medical Devices, the original medical device registration certificate shall be submitted.

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Question 2: How do medical device companies register 15 and get the device business license first? For details, please refer to the Measures for the Administration of Licenses for Medical Device Enterprises (Decree No.2004). 15).

With a business license, go to the industrial and commercial bureau for registration and get a business license according to normal procedures.

Question 3: What do you think the registration number of medical devices stands for? The arrangement of medical device registration number is changed to: X(X) 1 (Food) Drug Administration (X2) XXXX3No. X4XX5XXXX6。 These include:

X 1 is the abbreviation of the location of the registration examination and approval department. Class III medical devices in China, overseas medical devices and medical devices in Taiwan Province Province, Hongkong and Macau are designated as "China". The second category of medical devices in China refers to the provinces, autonomous regions and municipalities directly under the Central Government where the registration examination and approval departments are located. The first category of medical devices in China is the abbreviation of the province, autonomous region and municipality directly under the central government where the registration examination and approval department is located plus the abbreviation of the municipal administrative region where the registration examination and approval department is located, namely XX 1 (if there is no corresponding municipal administrative region with districts, it is only the abbreviation of the province, autonomous region and municipality directly under the central government);

X2 is the registration form (approval, entry and permission). The word "quasi" is suitable for domestic medical devices. The word "gold" is applicable to overseas medical devices. The word "Xu" is applicable to medical devices in Taiwan Province Province, Hongkong and Macau.

XXXX3 is the year of approval of registration;

X4 is a product management class;

XX5 is the product variety code;

XXXX6 is the registered serial number.

For example, in September 2004, the registration number of disposable sterile syringes registered in China was arranged as "US Food and Drug Administration (2004) No.315XXXX".

Question 4: How to register a medical device business enterprise? 1, the legal representative of the enterprise, the person in charge of the enterprise, and the quality management personnel shall not have the circumstances specified in Article 40 of the Regulations on the Supervision and Administration of Medical Devices;

2. An enterprise shall have a quality management organization or full-time quality management personnel suitable for its business scale and scope; Quality management personnel should have relevant professional qualifications or titles recognized by the state, and have professional and technical personnel who have obtained qualifications according to law. If the quality manager should be at work, not in other units.

3. It has a relatively independent business place suitable for its business scale and scope.

4. Having storage conditions (storage equipment and facilities) suitable for the business scale and scope.

5. Ability to provide technical training and after-sales service for products.

6, should according to the relevant provisions of the state and local, establish and improve the necessary quality management system, and strictly enforced.

7, should collect and save the national standards, industry standards and regulations, rules and special provisions of the supervision and management of medical devices.

8, in accordance with the "Guangdong Province set up medical device business enterprise acceptance implementation standards" for acceptance.

There are three key parts in applying for medical device license: housing, personnel and materials. Mingxi described the application process one by one

Requirements for housing application:

1. The requirements must be "office building" and "commercial land", but not "commercial land", "residential land" and "industrial land".

2. The office area is more than 35 square meters, and the warehouse area is more than 15 square meters.

3. The customer needs to provide the floor plan of the office area.

There are necessary office equipment in the office, such as desks, chairs and fax machines.

5. The warehouse floor is clean, preferably with air conditioning, ventilation and good light.

Requirements of the applicant:

1. At least three people are required to be present during the actual inspection: the person in charge of the company, the person in charge of quality and the quality inspector.

2. Person in charge of the company: no academic qualifications, no professional requirements, familiar with the industry, know how to operate and manage the company. Person in charge of quality: graduated from clinical medicine or related medicine (Chinese medicine is not accepted). Quality inspector: Class II requires graduation from technical secondary school or above; The third category requires college education or above; The original and my resume need to be provided during the actual inspection.

3. During the actual inspection, the above three people must be present. It is suggested that about 5 people be present, which can be the sales and warehouse manager of the company.

4. Customers need to provide copies of ID cards and mobile phone numbers of these 3-5 people to Mingxi.

Requirements for application materials:

1. Copy of the product registration certificate of the product to be sold. A copy of the product registration certificate is required for each medical device product.

2. The general agent shall provide the business license of medical devices, and the manufacturing enterprise shall provide the production and business license, as well as the copies of business license and tax registration certificate.

3. Labor contracts signed by all employees and the company.

4. The "distribution contract" or "authorized distribution book" given by the general agent or manufacturer to the customer.

5. All employees of the company attend the training certificate of each medical device product at the general agent or manufacturer.

6 enterprise standards, national standards and industry standards for the distribution of products.

To apply for the Medical Device Business License, customers need to cooperate closely with Mingxi Business before they can pass the examination of the Food and Drug Administration. At present, Mingxi has served hundreds of medical device enterprises to register for medical device business licenses, with a success rate of over 99%.

Question 5: What are the requirements for registering a medical device company? You need to find an organization to solve this problem. Chengdu Daye Finance can.

Question 6: How to apply for a medical device business license and what procedures are needed? Thank you for providing the following information. I don't know if it suits you. I suggest you go to the provincial and municipal food and drug administration to apply for a medical device business license, and then ask the relevant local departments, and they will usually tell you how to do it!

1. To apply for the Medical Device Business License, the following conditions shall be met:

(1) Having a quality management organization or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;

(2) Having a relatively independent business place suitable for its business scale and business scope;

(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;

(four) establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system;

(5) It shall have the technical training and after-sales service capabilities suitable for the medical device products it deals in, or agree to provide technical support by a third party.

II. Procedures for applying for the Medical Device Business License:

(1) The applicant shall submit an application for issuance of the Medical Device Business License to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the proposed enterprise is located or the (food) drug supervision and administration department of the city divided into districts entrusted by it.

The following materials shall be submitted when applying for the License of Medical Device Business Enterprise:

1 medical device business license application form;

2. Certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce;

3 copies of ID cards, academic qualifications or professional titles of the quality management personnel of the proposed enterprise and their resumes;

4. Organization and functions of the proposed enterprise;

5. A copy of the registered address of the proposed enterprise, the geographical location map of the warehouse address, the floor plan (indicating the area), and the house property certificate (or lease agreement);

6. Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise;

7. Business scope of the proposed enterprise.

(2) The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the municipal food and drug supervision and administration institutions entrusted by them shall deal with the application for the issuance of the Medical Device Business License submitted by the applicant according to the following circumstances:

1 If the application matters do not fall within the authority of the department, it shall immediately make a decision of rejection, issue a notice of rejection, and inform the applicant to apply to the relevant department;

If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

If the application materials are incomplete or do not conform to the statutory form, the applicant shall issue a Notice of Supplementary Materials on the spot or within five working days to inform all the contents that need to be supplemented at one time. Fails to inform, since the date of receipt of the application materials is accepted;

4. If the application matters fall within the functions and powers of the department, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, it shall issue a notice of acceptance. The acceptance notice shall be stamped with the special seal for acceptance and indicate the date of acceptance.

(3) The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted food and drug supervision and administration institutions at the municipal level with districts shall conduct on-site verification of the enterprises to be applied for according to the acceptance standards of medical device trading enterprises, and review the application materials in accordance with these Measures.

(four), provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall make a decision on whether to issue the "medical device business license" within 30 working days from the date of acceptance. If it meets the requirements, it shall make a decision on granting the medical device business license, and issue the medical device business license to the applicant within 10 days from the date of making the decision. Do not meet the conditions, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Question 7: How to register the second kind of medical devices online? Which province are you from? Different provinces have different policies. For example, Fujian Province directly submitted a paper application registration form to the Food and Drug Administration, while Zhejiang Province first submitted a data application to the Food and Drug Administration in official website to form a registration form, and then completed the registration in the Food and Drug Administration.

Specific landing: fredamd

Question 8: What information does a registered medical device company need to prepare? Information and conditions required for registering a medical device company:

Application conditions: warehouse area is greater than 15O, and office area is greater than 30O. According to the requirements of the Food and Drug Administration, Shanghai Registered Company Network will be launched to provide free registered address, and no fees will be charged in the coming year. This is undoubtedly a surprise for the medical device industry.

The registration process of medical device companies can also refer to the registration company process network and how to register the company's medical device network:

Name verification → capital verification → handling industrial and commercial business license (including seal) → handling organization code certificate → handling tax registration certificate.

The first step is to register a medical device company. Materials required for name check:

Application for pre-approval of 1. name;

2. The identity certificate of the investor;

3. Registered capital, contribution ratio and business scope;

Step 2 Application for License of Medical Device Business Enterprise

(1) Materials required for the letter of acceptance:

(1) Registration Form of Application Materials for Medical Device Business Enterprise License;

(2) Application Form for Shanghai Medical Device Business Enterprise License;

(3) A certificate of pre-approval of enterprise name or a copy of business license issued by the administrative department for industry and commerce;

(4) A copy of the ID card, education or professional title certificate and resume of the person in charge of quality management of the enterprise to be established;

(5) A copy of the ID card, education or professional title certificate of the quality management personnel of the enterprise to be established;

(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;

(7) A copy of the registered address of the proposed enterprise, the geographical location map of the warehouse address, the floor plan (indicating the area), the property right certificate of the house or the lease agreement (with the property right certificate of the leased house attached);

(8) The product quality management system document of the proposed enterprise (1 1 document) and the inventory of storage facilities and equipment;

(9) The business scope of the proposed enterprise shall be determined according to the management category and category code specified in the Catalogue of Medical Devices;

(10) Business license, product registration certificate (photocopy) and power of attorney of the entrusted seller of the products to be sold.

(1 1) Other supporting documents that need to be provided. Attachment: Specific requirements of application materials:

(2) Business License for Medical Devices

(1) After acceptance, the drug inspection department will conduct on-site inspection within 25 working days.

(2) Issue the Medical Device Business License within 10 working days from the date of making the decision to grant the license.

The third step of industrial and commercial registration materials, you can refer to the Shanghai registered company network:

1. Notice of pre-approval of enterprise name;

3, the shareholder's legal person qualification certificate or natural person identity certificate;

4. An application for registration of the establishment of an enterprise as a legal person signed by the company's chairman or executive director;

5. Resolution of shareholders' meeting (seal of shareholders and signature of natural person shareholders);

6. Resolution of the board of directors (signed by all directors);

7. Articles of Association (sealed by all shareholders), and the articles of association of the group limited company (sealed by the member enterprises of the group) shall also be submitted;

8. Documents indicating the names and residences of the company's directors, supervisors and managers, and certificates of appointment, election or employment, including:

(1) letter of appointment (wholly state-owned);

(2) Letter of appointment (sealed by the appointing unit);

(3) The certificates of appointment of the chairman or executive director, director, supervisor and manager of the company;

(4) Copies of the identity cards of the company's directors, supervisors and managers;

9. A capital verification report issued by a legally qualified capital verification institution;

10. the company's domicile certificate, and the lease agreement (with a copy of the property right certificate) must be submitted for renting the house;

1 1. If the business scope of the company belongs to the items that must be submitted for examination and approval according to laws and administrative regulations, the approval documents of relevant departments shall be submitted;

12. If the establishment of a limited liability company is subject to approval according to laws and administrative regulations, the approval documents of relevant departments shall be submitted;

13, a full set of application forms and other materials issued by our bureau.

Materials required for the fourth step of organization code:

1. Original and photocopy of business license (original and photocopy);

2. Identification certificate of the legal representative. ...& gt& gt

Question 9: What does a registered medical device company need to do? If the product is a business enterprise, I only need to apply for the industrial and commercial qualification for operating medical devices. If it is a production enterprise, I need to apply for the product registration certificate first, and then apply for the production registration form and industrial and commercial qualification. If it is a second-class product, the operating enterprise must have the industrial and commercial qualification to operate the second-class medical devices, and also have the record certificate of the second-class operation. If it is production, first of all, there must be a second-class product registration certificate and production license, as well as the corresponding industrial and commercial qualifications. Three types of products: business enterprises must have business licenses and industrial and commercial qualifications, and production enterprises must have three types of product registration certificates and production licenses and corresponding industrial and commercial qualifications.

Question 10: 1. How to handle the medical device product registration certificate? The following is learned from Ozda Medical Devices. The relevant documents have detailed provisions on this, and now I will give you the original text for reference: Article 5 The following materials shall be submitted for the registration of Class I medical devices produced by domestic enterprises: (1) Qualification certificate of medical device manufacturing enterprises. (2) registered product standards and compilation instructions. (3) Self-inspection report of product full performance. (four) the existing resource conditions and quality management capabilities of the enterprise's product production (including testing methods). (5) Instructions for use of the product. (6) A self-assurance statement on the authenticity of the submitted materials. Article 6 The following materials shall be submitted for trial production registration of Class II and Class III medical devices produced by domestic enterprises: (1) Qualification certificate of medical device manufacturing enterprises. (2) product technical report. ③ Safety risk analysis report. (four) the registered product standards and compilation instructions. (five) product performance self-inspection report. (6) Type test report of product trial production registration issued by the medical device quality testing institution recognized by the State Medical Device Administration in the past year (biological materials in the first half year of clinical trial). (seven) clinical trial reports of more than two clinical trial bases. Reports shall be provided in accordance with the Sub-Provisions on Clinical Trial Reports of Medical Device Registration (see Annex), and clinical trials shall be implemented in accordance with the Administrative Measures for Clinical Trials of Medical Device Products. (8) Product description. (9) A self-assurance statement on the authenticity of the submitted materials. Article 7 The following materials shall be submitted for the quasi-production registration of Class II and Class III medical devices produced by domestic enterprises: (1) Qualification certificate of medical device manufacturing enterprises. (2) A copy of the trial production registration certificate. (3) registered product standards. (4) Product improvement report during trial production. (five) effective certification documents of enterprise quality system evaluation (certification). (six) the product registration type test report issued by the medical device quality testing institution recognized by the State Pharmaceutical Products Administration in the last year. (seven) product quality tracking report. (8) A self-assurance statement on the authenticity of the submitted materials. Ozda medical devices only focus on medical devices in institutions.