Permits applicable to the verification of medical device production quality management system: first registration, change of registration, production license, non-textual change of production address, etc.

1. "Application Form for Change of Medical Device Production License";

2. A copy of the "Medical Device Production License" (including the "Medical Device Production Product Registration Form") or "Medical Device Manufacturing Enterprise License";

3. Description of the changes of the enterprise;

4. The self-guarantee statement of the authenticity of the application materials, including the company's commitment to the material to bear legal responsibility;

5. When applying for enterprise application materials, if the person handling the application is not the legal representative or the person in charge, the enterprise shall submit a Power of Attorney;

6. The electronic version of the submitted documents (each electronic file must not exceed 10M).

To increase the production of products, it should also submit:

(1) A copy of the registration certificate and product technical requirements of the added medical device;

(2) Catalogue of main production equipment and inspection equipment;

(3) Process flow chart of the products produced, and indicate the main control items and control points, including the description of the equipment, personnel and process parameters control of key and special processes;

If the added product is entrusted to produce, you also need to submit:

(1) A copy of the business license of the entrusting party and the entrusted party;

(2) A copy of the “Medical Device Production License” of the trustee;

(3) A copy of the commission for the production of medical equipment commissioned by the client;

(4) A copy of the commissioned production contract;

(5) The instructions and label samples to be used for the production of medical devices;

(6) The accreditation statement of the entrusting party to the quality management system of the trustee;

(7) The self-guarantee statement of the entrusting party regarding the responsibility for the quality, sales and after-sales service of the commissioned production of medical devices;

If the production address is not a textual change, it shall also be submitted:

(1) Proof of production site (planned use or design use should not be “residential”), including copy of lease agreement, property certificate (or proof of use right); plant location road map, factory floor plan, main production workshop The layout plan, the workshop with clean requirements, shall indicate the copy of the qualified test report of the clean room and the flow of the function, the flow of people, and the flow of the logistics (the test report shall be in compliance with the "Standards for the Management of Sterile Medical Devices" within one year (YY0033). Qualified test report);

(2) Process flow chart of the products produced, and indicate the main control items and control points, including the description of the equipment, personnel and process parameters control of key and special processes;

If the enterprise changes the name of the enterprise, the legal representative, the person in charge of the enterprise, the address of the residence or the change of the production address at the same time, it shall be merged according to this procedure, and the following application materials shall also be submitted:

To change the name of the company, you should submit:

A copy of the changed Business License issued by the administrative department for industry and commerce;

If you change your residence or legal representative, you should submit:

(1) A copy of the changed Business License issued by the administrative department for industry and commerce;

(2) A copy of the legal representative's identity certificate must be submitted at the same time as the change of the legal representative;

If you change the person in charge of the company, you should submit:

A copy of the identity certificate of the person in charge of the company after the change;

If the production address is changed in character, it shall be submitted:

Relevant supporting documents for the change of the address of the production address;

1. "Medical Equipment Entrusted Production Record Form";

2. A copy of the registration certificate entrusted to produce medical equipment;

3. A copy of the business license of the entrusting party and the entrusted party;

4. A copy of the “Medical Device Production License” (including the “Medical Device Production Product Registration Form”) or “Medical Device Manufacturing Enterprise License” of the trustee;

5. Entrust a copy of the production contract;

6. If the entrusted production is not a domestic medical device approved according to the special approval procedures for innovative medical devices, it shall also submit the “Medical Device Production License” (including “Medical Device Production Product Registration Form”) or “Medical Device Manufacturing Enterprise” of the entrusting party. A copy of the License; if it belongs to a domestic medical device approved in accordance with the special approval procedures for innovative medical devices, it shall submit the special approval certificate for innovative medical devices.

7. A self-assurance statement on the authenticity of the application materials, including the company's commitment to materially assume legal liability.

8. When applying for enterprise application materials, the handling personnel are not the legal representative or the person in charge, and the enterprise shall submit the Power of Attorney.

(1) Copy of business license and organization code certificate

(2) A copy of the registration certificate and technical requirements for the medical equipment produced by the applicant company

(3) Copy of the legal representative and the identity of the person in charge of the enterprise

(4) A copy of the identity, education and professional title of the person in charge of production, quality and technology

(5) List of qualifications and titles of employees in production management and quality inspection positions

(6) Proof of the production site, copy of the certificate of the facility and environment that should be submitted to the special production environment

(7) Catalogue of main production equipment and inspection equipment

(8) Quality manual and program documentation

(9) Process flow chart

(10) Certificate of authorization of the manager

(11) Other supporting documents

1. "Application Form for Medical Device License Change";

2. A copy of the Medical Device Business License; (the original inspection)

3. If you change the name of the company, you should also submit a copy of the changed business license; (hand in the original)

4. If the legal representative is changed, it shall also submit (1) a copy of the changed business license; (2) a copy of the legal representative's identity certificate, academic qualification or title certificate; (subject to the original)

5. If the person in charge of the enterprise is changed, it shall also submit: (1) a copy of the identity certificate, academic qualification or title certificate of the person in charge of the enterprise; (2) the branch of the unincorporated person of the enterprise legal person shall also submit the decision of the appointment and removal of the higher-level legal person enterprise and after the change. Copy of the business license; (original inspection)

6. If you change your address, you should submit a copy of the changed business license (original inspection);

7. When applying for enterprise application materials, if the specific handling personnel are not the legal representative or the person in charge, the enterprise shall submit a Power of Attorney;

8. Declare the material's authenticity self-assurance statement and make a commitment to the material if it is falsely liable.

(For those enterprises that have obtained the "Medical Device Business License", the application materials that have been submitted in their licensing items may not be submitted repeatedly when filing the "Second Type Medical Device Business Recording Voucher".

1. Medical Device Business License Continuation Application Form;

2. A copy of the business license (original inspection);

3. A copy of the Medical Device Business License; (the original inspection)

4. A copy of the legal representative, the person in charge of the enterprise, the person in charge of the quality, the certificate of academic qualifications or title (for the unified procurement channel, the illegal enterprise retail enterprise that takes chain operation, provides the identity certificate, academic qualification or professional title certificate of the person in charge of the chain enterprise headquarters. Copy); (hand in the original)

5. Organization and department setting instructions;

6. Geographical location map and floor plan of the business premises and warehouse (indicated area); proof of property rights and use rights of the warehouse; if the warehouse is set up across jurisdictions, it shall submit the “Setup of warehouses for the establishment of medical equipment management enterprises across jurisdictions”; , should submit the geographical location map, plan (area area) of the business site and a copy of the written agreement signed with the entrusted party, copy of the "medical device business license" of the entrusted party)

7. Operating facilities, equipment catalogue;

8. Management of quality management systems, work procedures and other documents;

9. Basic information and function description of computer information management system;

10. When applying for enterprise application materials, if the specific handling personnel are not the legal representative or the person in charge, the enterprise shall submit a Power of Attorney;

11. Declaration of authenticity of the material's self-assurance and commitment to the material if it is falsely liable;

1. "Second Class Medical Device Business Record Form";

2. A copy of the business license (original inspection);

3. A copy of the legal representative, the person in charge of the enterprise, the person in charge of the quality, the certificate of academic qualifications or title (for the unified procurement channel, the illegal enterprise retail enterprise that takes chain operation, provides the identity certificate, academic qualification or professional title certificate of the person in charge of the chain enterprise headquarters. Copy); (hand in the original)

4. Organization and department setting instructions;

5. Geographical map, floor plan (indicated area) of the business premises and warehouse, copy of the property certificate and the right to use certificate of the warehouse; (for the storage, the geographical location map, plan (area area) and entrusted shall be submitted to the business premises A copy of the written agreement signed by the party and a copy of the second type of medical device operation record certificate issued by the entrusted party)

6. Operating facilities, equipment catalogue;

7. Management of quality management systems, work procedures and other documents;

8. Basic information and functional description of the computer information management system (if any);

9. When applying for enterprise application materials, the specific handling personnel are not the legal representative or the person in charge, and the enterprise shall submit the Power of Attorney;

10. Declare the material's authenticity self-assurance statement and make a commitment to the material if it is falsely liable.

1. Medical Device Business License Application Form

2. Business license

3. Copy of the legal representative, the person in charge of the enterprise, the person in charge of the quality, the certificate of academic qualifications or title

4. Organization and department setting instructions

5. Geographical map and floor plan of the business premises and warehouse (indicating the area); copy of the property certificate and the right to use certificate of the warehouse

6. Operating facility, equipment catalog

7. Management quality management system, working procedures and other documents

8. Basic information and function description of computer information management system

9. Declaration material authenticity self-guarantee statement

CE certification consulting program

1. Status survey and diagnosis: Understand the current status of product technical documents, and modify the plan according to the investigation and diagnosis results (if necessary);

2. Training 1: EN ISO 13485:2003/AC:2009, EN ISO 14971:2009, MDD, CE technical documentation, etc.;

3. Write/modify quality management system documents: quality manuals, program files, etc.

4. Prepare the prototype/sample

5, product testing

6. Prepare, organize and prepare some CE technical documents: product description, product standard, risk management report, drawings, material quality standards, process documents, inspection specifications or procedures, production and inspection forms, confirmation of special processes, Test and/or third-party testing) test reports, clinical data, labels and instructions, etc., preparation of other CE technical documents (basic requirements checklist, basisd regulations, list of standards, EU representative authorization, declaration of conformity, etc.)

[Description]: The CE technical documents are listed in the list.

7. Discuss, modify, approve documents

8. Document printing and distribution

9. Training 2: Technical documents such as quality manuals, program documents, and management systems;

10. Implement the quality management system documents: work in accordance with the system documents to form a record of the work results;

11. The first internal audit

12. The second internal audit

13. management review

14. Certification audit (external review)

15. rectification

16. forensics