The registration (re-registration) of Class I medical devices within the territory consists of acceptance and administrative examination and approval processes. The total time limit for approval is within 30 working days from the date of issuance of the acceptance notice.
I. Acceptance
Mainly on the territory of the first class of medical devices registration (re-registration) application materials for formal review, to ensure that the application materials are complete and standardized, and to the public announcement of the acceptance of the situation.
Medical device manufacturers applying for registration (re-registration) of Class I medical devices within the territory, should be the location of the municipal (food) drug supervision and management department to submit the required registration application materials.
(A) acceptance requirements
1. "Domestic Medical Device Registration Application Form"
Applicant enterprises to fill in the "Domestic Medical Device Registration Application Form" should be signed by the legal representative and stamped with the official seal, the items filled out should be complete, accurate, fill in the content should meet the following requirements:
(1) "Manufacturer Name", "registered address" is the same as the "Business License";
(2) "product name", "specification model" and The name and specification model used in the submitted product standards, test reports and other application materials are the same.
2. Proof of qualification of medical device manufacturers
Proof of qualification includes a copy of the "Class I Medical Device Manufacturer Registration Form" and a copy of the "Business License".
(1) The product for which registration (re-registration) is applied for shall be within the approved production scope of the "Registration Form for Class I Medical Device Manufacturing Enterprises";
(2) The "Industrial and Commercial Business License" is within the validity period.
3. Applicable product standards and instructions
The product standards submitted by the applicant enterprise can be national standards, industry standards or registered product standard text.
(1) the use of national standards, industry standards as product standards, should be submitted to the adopted national standards or industry standards of the valid text and the adoption of the standard description;
(2) the use of registered product standards as product standards, should be submitted to the official text of the registered product standards and their preparation instructions.
4. Product full performance test report
Product full performance test report should include the following:
(1) product name, specifications, product number or batch number, date of production, number of samples, the sampling base;
(2) the basis for the test, test items, standard requirements, test results, the results of the judgment, the inspector, the auditor Signature or seal, date of inspection, etc.;
(3) If the test is commissioned, the commissioned testing organization should provide a test report and commissioned inspection agreement.
5. Existing resource conditions for the production of products and quality management capabilities (including testing methods) of the description
Enterprise product production of existing resource conditions and quality management capabilities (including testing methods) of the description should include the following:
(1) apply for the enterprise's existing resource (human resources, infrastructure, working environment, etc.) conditions, management capabilities, production capacity
(2) Provide a list of production equipment, testing instruments and product testing of measuring instruments required for the validity of the verification certificate (copy).
6. Medical device specifications
Medical device specifications should include at least the following:
(1) product name, model number, specifications;
(2) the name of the manufacturer, the registered address, production address, contact information;
(3) "Medical Device Manufacturer's License" No., the medical device certificate of registration No. (the content of the declaration is blank), the product is not required. The content of the declaration is blank), product standard number;
(4) the performance of the product, the main structure, scope of application.
7. Product quality tracking report (chicken for re-registration)
Product quality tracking report should include the following:
(1) the enterprise's quality control measures for the product and the internal audit of the product quality of the review of the situation;
(2) in the use of the product, the user feedback on product quality;
(3) product quality in the product cycle inspection, routine factory inspection; product quality supervision and sampling above the provincial level (food) drug supervision and management department;
(4) the implementation of the adverse event monitoring system and the monitoring of adverse events;
(5) information collected by the enterprise on product quality, statistical analysis and the measures taken and validation of the situation.
8. Original medical device registration certificate (for re-registration)
(1) belonging to the "Measures for the Administration of Registration of Medical Devices" Chapter V, Article 33 of the circumstances, should be submitted to the original certificate of registration of medical devices;
(2) belonging to the "Measures for the Administration of Registration of Medical Devices" Chapter V, Article 34, Article 35 of the circumstances, should be submitted to the original certificate of registration of medical devices. The original certificate of registration.
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Question 2: How to register a medical device company 15 points First get the device license, see "Medical Device Business License Management Measures" (Bureau Decree No. 15)
With the business license, according to the normal procedures to the Commerce and Industry Bureau to register, and get the business license, etc.
Question 3: How to look at the registration number of the medical device, all represent What? The arrangement of medical device registration number changed to: X (X) 1 (food) Drug Supervision and Measures (X2) word XXXX3 X4XX5XXXXXX6. Where:
X1 is the abbreviation of the location of the registration and approval department. Within the third class of medical devices, overseas medical devices and medical devices in Taiwan, Hong Kong, Macao for the "country". Within the second class of medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government abbreviation. Domestic Class I medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government for short plus the short name of the municipal administrative region, XX1 (no corresponding municipal administrative region, only for the province, autonomous region, municipality directly under the Central Government for the short name);
X2 for the form of registration (permitted, into the permit, permit). The word "permitted" applies to medical devices within the country. The word "into" applies to foreign medical devices. The word "permit" applies to medical devices in Taiwan, Hong Kong and Macao;
XXXX3 is the year of approval for registration;
X4 is the product management category;
XX5 is the product variety code;
XXXX6 is the registration number.
such as the domestic 204 September allowed the registration of the production of single-use sterile syringes registration number is arranged in the form of "state (food) drug supervision and mechanical (quasi) word 2004 No. 315 XXXX"
Question 4: How to register medical equipment business enterprises? 1, the legal representative of the enterprise, the person in charge of the enterprise, the quality management personnel should not be "supervision and management of medical devices regulations" Article 40 of the situation;
2, the enterprise should have with the scale and scope of business operations of the quality management organization or full-time quality management personnel; quality management personnel should have a state-recognized professional qualifications or titles, with the qualification of professional and technical personnel according to law. Technical personnel. Such as quality management personnel should be on duty, not in other units ***
3, with the scale and scope of operation of relatively independent business premises.
4, with storage conditions (storage equipment, facilities) appropriate to the scale and scope of business.
5, with the operating products for technical training, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.
8, in accordance with the "Guangdong Province to start the medical device business acceptance of the implementation of standards" acceptance.
The three most critical parts of the application for a medical device license: housing, personnel, materials, MINGXI the following one by one to explain the application process
Application for housing requirements:
1, the requirements must be "office building" "commercial purposes "etc.".
2. The office area is above 35 square meters and the warehouse area is above 15 square meters.
3, the customer needs to provide the floor plan of this office area.
4, the office space has the necessary desks and chairs, fax and other office equipment.
5, the warehouse floor is clean, preferably air-conditioned, ventilated, well lit
Applicants Requirements:
1, the actual inspection, requires at least three people present: the person in charge of the company, the person in charge of the quality of the quality of the inspectors
2, the person in charge of the company: there is no educational requirements, there is no professional requirements, require familiarity with the industry, understand the operation and management, said the company is how to operate and manage the company. The company is how to operate and manage. The quality of the person in charge: clinical medicine or related medical graduates (Chinese medicine can not). Quality inspectors: two types of requirements for secondary school graduates; three types of requirements for college graduates; the actual inspection needs to provide the original, and provide the person's personal resume.
3, the actual inspection, the above three people must be present, it is recommended that the presence of about five people, can be the company's sales, warehouses, such as the position of the person in charge.
4, the customer is required to provide a copy of the ID card of these 3-5 people, cell phone number to Mingxi.
Application material requirements:
1, want to sell the product of the product registration certificate copy, each medical device products need to get a copy of the product registration certificate.
2, the general agent to provide the "Medical Device Business License", the manufacturer to provide the "Manufacturing License", while providing a copy of the business license, tax registration certificate and so on.
3, all employees and the company signed the Employment Contract.
4, the general agent or manufacturer to the customer's "distribution contract" or "authorized distribution letter.
5, all employees of the company to the general agent or manufacturer to participate in each medical device product training certificate.
6, the distribution of product standards, national standards, industry standards.
Applying for a Medical Device License requires close cooperation between the customer and Mingshi Business before the company can finally and successfully pass the audit by the Drug Administration. At present, Mingshi has served hundreds of medical device company registrations and medical device licenses, and the success rate of the process is over 99%.
Question 5: What are the requirements for registering a medical device company? This you need to find an agent to solve the problem can be Chengdu Daye Finance can
Question six: how to apply for medical equipment business license, what procedures are required? Thank you There are the following information, I do not know if it is appropriate for you? It is recommended that you first to the provincial and municipal Drug Administration to apply for a medical device license, and then ask the local authorities, they will generally tell you how to do!
Application for a "medical device business license" should also have the following conditions:
(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(e) should have its business with the medical device products appropriate technical training and after-sales service capabilities, or agreed to provide technical support by a third party.
Two, apply for a "medical device business license" procedures:
(a), the applicant should be to the proposed business location of the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies to submit a "medical device business license" application for issuance of licenses.
Application for "Medical Device Business License" should be submitted as follows:
1 "Medical Device Business License Application Form";
2 industrial and commercial administration issued by the business name pre-approval of documents;
3 proposed enterprise quality management personnel identity card, academic or professional title certificates and copies of the resume; < /p>
4 proposed enterprise quality management personnel.
4 proposed enterprise organization and function;
5 proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), proof of property rights (or lease agreement) copy;
6 proposed enterprise product quality management system documents and storage facilities, equipment directory;
7 proposed business scope.
(2), for the applicant to put forward the "medical device business license" licensing application, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies should be entrusted to deal with the following situations:
1 application does not fall within the purview of the department, it should be made instantly inadmissible Acceptance of the decision, issued a "Notice of Inadmissibility", and inform the applicant to the relevant departments;
2 application materials can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
3 application materials are incomplete or do not meet the legal form, should be issued on the spot or within five working days to the applicant "Notice of Corrective Material", a one-time notice of All the contents that need to be corrected. Late notification, from the date of receipt of the application materials shall be accepted;
4 application matters within the purview of the department, the application materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all the corrective application materials, issued a "Notice of Acceptance". Notice of Acceptance" shall be stamped with a special seal of acceptance and the date of acceptance.
(c), provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the commissioned area based on medical device business inspection and acceptance criteria for the proposed business on-site verification, and in accordance with this approach to the review of the application materials.
(d), provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments should be accepted within 30 working days from the date of issuance of "medical device business license" decision. Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of the decision to the applicant to issue "medical device business license". Considered does not meet the requirements, shall notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
Question 7: How to register Class II medical devices online Which province are you from? Different provinces have different policies, for example, Fujian Province directly to the Food and Drug Administration to submit a paper application registration form, Zhejiang Province, the first to the official website of the Food and Drug Administration to submit information to apply for the formation of the registration form and then to the Food and Drug Administration to complete the registration process.
Specifically, you can login: fredamd
Question 8: What information do I need to prepare to register a medical device company? The information and conditions needed to register a medical device company:
Application conditions: warehouse area greater than 15O, office area greater than 30O, and in accordance with the requirements of the Pharmaceutical Supervision Bureau layout, the Shanghai registered company network launched a free to provide a registered address, the next year does not levy fees, this is undoubtedly a surprise for the medical device industry.
Medical equipment company registration process can also refer to the registration process network and how to register a company medical equipment network:
Name check → capital verification → for business license (including engraved seal) → for organization code certificate → for tax registration certificate.
The first step in the registration of medical equipment company name check required materials:
1. name pre-approval application;
2. investor identification;
3. registered capital, the proportion of capital contribution, the scope of business;
The second step in the medical equipment business license application
(a) "Acceptance of the notification of the materials required:
(1) "Medical Device Business License Application Materials Registration Form";
(2) "Shanghai Medical Device Business License Application Form";
(3) business administration department issued by the pre-approval of the enterprise name of the document certifying that the business or a copy of the "business license";
(4) the proposed enterprise quality management person in charge of identity card, Academic qualifications or certificates of title and a copy of personal resume;
(5) proposed enterprise quality management personnel identity card, academic qualifications or certificates of title;
(6) proposed enterprise organization and functions or full-time quality management personnel functions;
(7) proposed enterprise registered address, warehouse address of the geographic location of the map, the floor plan (with the area), Proof of ownership of the house or a copy of the lease agreement (with proof of ownership of the leased house);
(8) the proposed enterprise product quality management system documents (11 documents) and storage facilities, equipment directory;
(9) the proposed business scope of the enterprise, in accordance with the provisions of the Medical Device Classification Directory of the management of the category, the name of the class code to determine;
(10) to be sold The commissioned seller of the product business license and product registration certificate (copy), authorization.
(11) Other supporting documents to be provided. Attachment: specific requirements for application materials:
(B) "Medical Device Business License"
(1) approved the acceptance of 25 working days after the drug inspection department on-site inspection.
(2) 10 working days from the date of the decision to grant permission to issue the "Medical Device Business License".
The third step of the required materials for business registration, you can refer to the Shanghai registration company network:
1, notice of pre-approval of enterprise name;
3, shareholders of the certificate of legal personality or a natural person's identity;
4, the chairman of the board of directors of the company or the executive director of the company signed an application for the establishment of the registration of the enterprise legal person;
5, the resolution of the shareholders' meeting ( Shareholder's seal, natural person shareholder's signature);
6, board of directors' resolution (signed by all directors);
7, articles of association (all shareholders' seal), group limited company is also required to submit the group's articles of association (stamped by the group's member enterprises);
8, documents stating the names and residences of the company's directors, supervisors, and managers as well as certificates of relevant appointments, elections, or employments (1) letter of appointment (wholly state-owned);
(2) letter of appointment (seal of the appointing unit);
(3) certificate of appointment of the chairman of the board of directors or executive director of the company, directors, supervisors, managers;
(4) copy of ID card of the directors, supervisors and managers of the company;
9. Capital verification report issued by the legally qualified capital verification institution;
10. The capital verification report issued by a legally qualified institution;
10, the company's domicile certificate, rental housing should be submitted to the lease agreement (with a copy of the property rights certificate);
11, the company's business scope, belonging to the laws and administrative regulations must be reported to the approval of the project, submitted to the approval of the relevant departments of the document;
12, the establishment of a limited liability company shall be reported to the approval of the law or administrative regulations, submitted to the relevant departments for approval. If the establishment of a limited liability company is required by laws and administrative regulations to be submitted for approval, submit the approval documents of the relevant departments;
13. A full set of registration forms and other materials issued by the Bureau.
The fourth step of the agency code required materials:
1, business license original and copy (original, copy);
2, the legal representative of the ID... >>
Question nine: self-registration of a class of medical equipment companies need to do If a class of products: operating enterprises, that only need to handle the operation of a class of medical equipment industry and commerce qualification can be, if it is the production of enterprises that have to first apply for a class of products for the record vouchers, and then apply for a class of production for the record registration form and industry and commerce qualification. If it is a class II products, operating enterprises in addition to business class II medical device business qualification, but also class II business filing certificate, if it is the production of the first class of product registration certificate and production license, the corresponding business qualification. Class III products: business enterprises, to have a business license and industrial and commercial qualifications, production enterprises to have Class III product registration certificate and production license, the corresponding industrial and commercial qualifications.
Question 10: How to apply for a medical device product registration certificate? The following is learned from the Aojida medical equipment. The relevant provisions of the document is, which made detailed provisions, now give you the original text for reference: Article V domestic enterprises to produce the first class of medical devices for registration, the following materials should be submitted: (a) medical device manufacturer qualification certificate. (B) registered product standards and preparation instructions. (C) product full performance self-test report. (D) the enterprise product production of existing resource conditions and quality management capabilities (including testing methods) of the description. (E) product instructions. (F) Self-assurance statement of the authenticity of the submitted materials. Article domestic enterprises to produce the second class, the third class of medical devices trial production registration shall submit the following materials: (A) medical device manufacturer qualification certificate. (B) product technical reports. (C) safety risk analysis report. (D) registered product standards and preparation instructions. (E) product performance self-test report. (F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registered type test report. (G) more than two clinical trial sites of clinical trial reports. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Appendix), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures". (H) product instructions. (Ix) the submitted material authenticity of the self-assurance statement. Article 7 Domestic enterprises to produce the second class, the third class of medical devices quasi-production registration shall be submitted to the following materials: (a) medical device manufacturer qualification certificate. (B) A copy of the trial production registration certificate. (C) registered product standards. (D) trial production during the product improvement report. (E) enterprise quality system assessment (certification) of valid documents. (F) the State Drug Administration recognized medical device quality testing organizations within the past year issued by the product type test report for production registration. (G) product quality tracking report. (H) the authenticity of the materials submitted to the self-assurance statement. Aojida medical devices in the organization only focus on medical devices.