Service Introduction

Huaguang Taihe provides domestic registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, quality system establishment and guidance, registration data preparation and review, declaration and tracking, etc., registration and evidence collection, production license or registrant system It provides full service for product market access.

  Service Content

1. Guidance and services for writing technical requirements for registered products, tracking and coordination services for product inspection;

2. Registered product risk management report, safe and effective list, writing of summary data and counseling services;

3. Research materials, including validity period verification, sterilization verification, packaging verification and other process verification writing and counseling services

4. Writing and counseling services for exempted clinical evaluation reports of registered products and comparison reports of non-exempted products with the same variety;

5. Register for other document writing and tutoring services;

6. Quality system establishment, operation guidance, simulation assessment and post-assessment rectification services;

7. Submission of product registration materials, review and tracking, and collection of registration certificates.

  Prepare materials

1. The product manual is provided (at least: product photos, model specifications, structural principle characteristics, performance parameters);

2. Product performance indicators and inspection methods; production process provision (process flow chart (main control points must be indicated, that is, key processes and special processes) The specific production process of the main components);

3. Product material list, quality agreement for key materials, purchase contract, etc.

4. Compare product information, such as instructions, registration certificates, etc.;

5. Power of Attorney;

Service workflow and cycle

Item Hours/days Client work
Huaguang Taihe work

contract time
first day

Both parties sign a written contract or agreement
Preliminary preparation

resource assessment

5

The customer provides the basic information of the company and products, including company qualifications, product information, production technology, environment, facilities and equipment, supplier information, etc. Understand the customer's basic information, including organizational structure, system coverage, system construction, personnel, and main product processes Process, main material sources, resources and other information, if necessary, on-site investigation
Quality system establishment and operation guidance
throughout the project

The whole process

Company organization, function allocation, resource provision, R&D process data, sample raw material procurement, production and other inspection documents and records Assist the company in organizational structure division, function allocation, personnel capacity confirmation, R&D process data, sample raw material procurement, production and other inspection documents and records Record creation and specification
Preparation of inspection documents Product technical requirements Product manual
20

Product basic data, functional information, structural composition, clinical application scope, design basis, product operating instructions and other technical documents Provide technical requirements templates, product compliance information, standard information, etc., to assist in the preparation of product technical requirements and instructions
Auxiliary product inspection
30-60

EMC/biocompatibility may be extended

Finalize the product technical requirements and instructions, prepare the product technical requirements and instructions for stamping, confirm the functional modules and clinical application scope, and express them to Party B. until the final inspection report is obtained
Prepare product registration data and research data to meet the application requirements
30

Some documents of research data will be extended according to different products.

Technical personnel assist in the preparation of product application materials, submit the product application technical documents to Party B for improvement and review, and revise and improve according to Party B's review comments, and prepare clinical evaluation (exemption applicable) reports. Party A's technicians will make improvements, review the documents provided by Party A and put forward rectification opinions, and review the results after rectification to meet the registration requirements
Clinical trials (non-exempt product clinical trials)
The specific time period is reflected in the clinical program

Cooperation in clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, device use training, trial enrollment, etc. Assist in institution selection, clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, and device use training , trial enrollment and other work, until the clinical trial is completed and the report is issued
Registration declaration

Review time

5

60

The product registration inspection report/entrusted inspection report/clinical trial report should be declared within 2 weeks after obtaining the registration data, and the registration data will be printed, stamped and scanned. After submitting the acceptance data, pay the fee as required and enter the review stage. The enterprise confirms, sorts out the report, and obtains the product acceptance notice. After the enterprise needs to pay the fee (if any), it will enter the review stage.
System assessment report
10

After the system documents are completed and pass the preliminary acceptance of Party B, the application for system assessment will be submitted within 10 working days of registration acceptance. The preparation of system assessment application materials will be completed, and the internal audit and pre-audit will be completed (applicable to the system at the same time). Reporting system assessment data
System assessment
30

To meet the system assessment, the system assessment time is generally arranged within 1 month after the application, and the assessment time is calculated within the review cycle. when applicable)
Registration and supplement

Review time

Correction period of 12 months

60

Waiting for registration and supplementation Assist in the improvement of registration and supplementary materials, and pre-examination of application for supplementary materials if conditions permit
Registration approval
20

The approval time of the drug regulatory department is waiting for the approval document to be issued
Obtain a certificate of registration
10

Waiting for evidence collection to receive product registration approval

Service Introduction

Huaguang Taihe provides domestic registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, quality system guidance, registration data preparation and review, declaration and tracking, etc., registration and evidence collection, production license or entrustment under the registrant system Production and other important links, provide full service for product market access.

  Service Content

1. Guidance and services for writing technical requirements for registered products, tracking and coordination services for product inspection;

2. Registered product risk management report, safe and effective list, writing of summary data and counseling services;

3. Analysis performance evaluation, stability study, positive judgment value or reference interval determination data writing and counseling services

4. Writing and counseling services for exempted clinical evaluation reports of registered products and comparison reports of non-exempted products with the same variety;

5. Production and self-inspection records, registration and other document writing and counseling services;

6. Quality system establishment, operation guidance, simulation assessment and post-assessment rectification services;

7. Submission of product registration materials, review and tracking, and collection of registration certificates.

  Prepare materials

1. The product manual is provided (at least: product photos, model specifications, structural principle characteristics, performance parameters);

2. Product performance indicators and inspection methods; production process provision (process flow chart (main control points must be indicated, that is, key processes and special processes) The specific production process of the main components);

3. List of product materials, quality agreements for key materials, procurement contracts, etc.; raw material research materials, etc.;

4. Compare product information, such as instructions, registration certificates, etc.;

5. Power of Attorney;

The characters in the flow chart below are too close together, and the work of both parties is unclear. Adjust according to the one above. All the following are adjusted;

Service workflow and cycle

Item Hours/days Client work
Huaguang Taihe work

contract time
first day

Both parties sign a written contract or agreement
Preliminary preparation

resource assessment

5

The customer provides the basic information of the company and products, including company qualifications, product information, production technology, environment, facilities and equipment, supplier information, etc. Understand the customer's basic information, including organizational structure, system coverage, system construction, personnel, and main product processes Process, main material sources, resources and other information, if necessary, on-site investigation
Quality system establishment and operation guidance
throughout the project

The whole process

Company organization, function allocation, resource provision, R&D process data, sample raw material procurement, production and other inspection documents and records Assist the company in organizational structure division, function allocation, personnel capacity confirmation, R&D process data, sample raw material procurement, production and other inspection documents and records Record creation and specification
Preparation of inspection documents Product technical requirements Product manual
20

Product basic data, functional information, structural composition, clinical application scope, design basis, product operating instructions and other technical documents Provide technical requirements templates, product compliance information, standard information, etc., to assist in the preparation of product technical requirements and instructions
Auxiliary product inspection
30-60

EMC/biocompatibility may be extended

Finalize the product technical requirements and instructions, prepare the product technical requirements and instructions for stamping, confirm the functional modules and clinical application scope, and express them to Party B. until the final inspection report is obtained
Prepare product registration data and research data to meet the application requirements
30

Some documents of research data will be extended according to different products.

Technical personnel assist in the preparation of product application materials, submit the product application technical documents to Party B for improvement and review, and revise and improve according to Party B's review comments, and prepare clinical evaluation (exemption applicable) reports. Party A's technicians will make improvements, review the documents provided by Party A and put forward rectification opinions, and review the results after rectification to meet the registration requirements
Clinical trials (non-exempt product clinical trials)
The specific time period is reflected in the clinical program

Cooperation in clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, device use training, trial enrollment, etc. Assist in institution selection, clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, and device use training , trial enrollment and other work, until the clinical trial is completed and the report is issued
Registration declaration

Review time

5

60

The product registration inspection report/entrusted inspection report/clinical trial report should be declared within 2 weeks after obtaining the registration data, and the registration data will be printed, stamped and scanned. After submitting the acceptance data, pay the fee as required and enter the review stage. The enterprise confirms, sorts out the report, and obtains the product acceptance notice. After the enterprise needs to pay the fee (if any), it will enter the review stage.
System assessment report
10

After the system documents are completed and pass the preliminary acceptance of Party B, the application for system assessment will be submitted within 10 working days of registration acceptance. The preparation of system assessment application materials will be completed, and the internal audit and pre-audit will be completed (applicable to the system at the same time). Reporting system assessment data
System assessment
30

To meet the system assessment, the system assessment time is generally arranged within 1 month after the application, and the assessment time is calculated within the review cycle. when applicable)
Registration and supplement

Review time

Correction period of 12 months

60

Waiting for registration and supplementation Assist in the improvement of registration and supplementary materials, and pre-examination of application for supplementary materials if conditions permit
Registration approval
20

The approval time of the drug regulatory department is waiting for the approval document to be issued
Obtain a certificate of registration
10

Waiting for evidence collection to receive product registration approval

Service Introduction

Huaguang Taihe provides domestic registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, quality system guidance, registration data preparation and review, declaration and tracking, etc., registration and evidence collection, production license or entrustment under the registrant system Production and other important links, provide full service for product market access.

  Service Content

1. Guidance and services for writing technical requirements for registered products, tracking and coordination services for product inspection;

2. Registered product risk management report, safe and effective list, writing of summary data and counseling services;

3. Research materials, including validity period verification, sterilization verification, packaging verification and other process verification writing and counseling services

4. Writing and counseling services for exempted clinical evaluation reports of registered products and comparison reports of non-exempted products with the same variety;

5. Register for other document writing and tutoring services;

6. Quality system establishment, operation guidance, simulation assessment and post-assessment rectification services;

7. Submission of product registration materials, review and tracking, and collection of registration certificates.

  Prepare materials

1. The product manual is provided (at least: product photos, model specifications, structural principle characteristics, performance parameters);

2. Product performance indicators and inspection methods; production process provision (process flow chart (main control points must be indicated, that is, key processes and special processes) The specific production process of the main components)

3. Compare product information, such as instructions, registration certificates, etc.;

4. Power of Attorney;

Service workflow and cycle

Project Time/Working Days Client Work Huaguang Taihe Work
Signing time First day Both parties sign a written contract or agreement
Preliminary preparation and assessment of basic resources 10 Provide basic information of customer enterprises and products, including enterprise qualification, product information, production process, environment, facilities and equipment, supplier list, etc. Understand basic customer information, including organizational structure, system coverage, and system documents , product main process flow, main material source, resources and other information, on-site investigation if necessary
Quality system establishment, operation coaching throughout the whole process of the project Company organization, function allocation, resource provision, R&D process data, sample raw material procurement, production and other inspection documents and records Coaching company organization division, function allocation, personnel ability confirmation, and R&D process data , the establishment and specification of inspection documents and records such as sample raw material procurement, production, etc.
20. Technical documents such as product basic data, functional information, structural composition, clinical application scope, design basis, product operation instructions, etc. Provide basic template of technical requirements, product compliance information, standard information, etc., to assist in the completion Preparation of product technical requirements and instructions
Auxiliary product inspection 30-90 EMC/biocompatibility will be extended Finalize product technical requirements and instructions, prepare product technical requirements and instructions for stamping, confirm functional modules and clinical application scope, and express to Party B Party B is responsible for screening inspection agencies and sending them ***Pre-examination by the inspection institute, and entrusted inspection after the pre-examination, inspection tracking, and finally obtaining the inspection report
Compile product registration information and verification information, meet the application requirements 30 Technical personnel assist in compiling product application information, submit product application technology to Party B for improvement and review, and revise and improve according to Party B's review opinions, and prepare clinical evaluation report Submit product registration information After preliminary preparation according to product characteristics, submit it to Party A's technical staff for improvement, review the documents provided by Party A and put forward rectification opinions, and review the results after rectification
Clinical trials (non-exempt product clinical trials) The specific time period is reflected in the clinical protocol. The clinical trial protocol, determination of clinical institutions, protocol discussion, approval of ethics committees, device use training, trial enrollment, etc. Cooperation assistance in institution selection, clinical trials Coordination of plans, determination of clinical institutions, discussion of plans, approval of ethics committees, training on device use, trial enrollment, etc., until the completion of clinical trials and reporting
Registration declaration

Review time

5

90

The product registration inspection report/entrusted inspection report/clinical trial report is declared within 2 weeks after obtaining the registration information, and the registration information is prepared for printing, stamping and scanning. Confirm, sort out and report, and obtain the product acceptance notice, and notify the enterprise that needs to pay the fee to pay the fee (if any), and then enter the review stage
System assessment and declaration 10 After the system documents are completed and pass the preliminary acceptance of Party B, the system assessment will be declared within 10 working days after the registration and declaration.
Registration and supplement

Review time

Correction period of 12 months

60

Waiting for registration and supplementation Assist in the improvement of registration and supplementary materials, and pre-examination of application for supplementary materials if conditions permit
Registration approval 20 Time for approval by the drug regulatory department Waiting for the approval document to be issued
Obtain the registration certificate 10 Wait for the evidence collection Get the product registration approval

Service Introduction

Huaguang Taihe provides domestic registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, quality system guidance, registration data preparation and review, declaration and tracking, etc., registration and evidence collection, production license or entrustment under the registrant system Production and other important links, provide full service for product market access.

  Service Content

1. Guidance and services for writing technical requirements for registered products, tracking and coordination services for product inspection;

2. Registered product risk management report, safe and effective list, writing of summary data and counseling services;

3. Analysis performance evaluation, stability study, positive judgment value or reference interval determination data writing and counseling services

4. Writing and counseling services for exempted clinical evaluation reports of registered products and comparison reports of non-exempted products with the same variety;

5. Production and self-inspection records, registration and other document writing and counseling services;

6. Quality system establishment, operation guidance, simulation assessment and post-assessment rectification services;

7. Submission of product registration materials, review and tracking, and collection of registration certificates.

  Prepare materials

1. The product manual is provided (at least: product photos, model specifications, structural principle characteristics, performance parameters);

2. Product performance indicators and inspection methods; production process provision (process flow chart (main control points must be indicated, that is, key processes and special processes) The specific production process of the main components);

3. Compare product information, such as instructions, registration certificates, etc.;

4. Power of Attorney;

Service workflow and cycle

Item Hours/days Client work
Huaguang Taihe work

contract time
first day

Both parties sign a written contract or agreement
Preliminary preparation and basic resource assessment
10

Provide basic information of customer enterprises and products, including enterprise qualification, product information, production process, environment, facilities and equipment, supplier list, etc. Understand basic customer information, including organizational structure, system coverage, system documents, main product process, main Material sources, resources and other information, and on-site investigation if necessary
Quality system establishment and operation guidance
throughout the project

The whole process

Company organization, function allocation, resource provision, R&D process data, sample raw material procurement, production and other inspection documents and records Assist the company in organizational structure division, function allocation, personnel capacity confirmation, R&D process data, sample raw material procurement, production and other inspection documents and records Record creation and specification
Preparation of inspection documents Product technical requirements Product manual
20

Basic product data, functional information, structural composition, clinical application scope, design basis, product operation instructions and other technical documents Provide basic templates of technical requirements, product compliance information, standard information, etc., and assist in the preparation of product technical requirements and instructions
Auxiliary product inspection
30-90

EMC/Biocompatible

sex will prolong

Finalize the product technical requirements and instructions, prepare the product technical requirements and instructions for stamping, confirm the functional modules and clinical application scope, and express them to Party B. Party B is responsible for screening the inspection institutions, and sending them to the *** inspection institute for pre-examination, as well as the entrusted inspection after the pre-examination. Inspection and tracking, until the final inspection report is obtained
Prepare product registration information and verification information to meet application requirements
30

Technicians assist in the preparation of product application materials, submit product application technology to Party B for improvement and review, and revise and improve according to Party B's review comments, and compile clinical evaluation reports. Preliminarily prepare product registration materials according to product characteristics and then submit them to Party A's technical staff for review. Improve, review the documents provided by Party A and put forward rectification opinions, and review the results after rectification
Clinical trials (non-exempt product clinical trials)
The specific time period is reflected in the clinical program

Cooperation in clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, device use training, trial enrollment, etc. Assist in institution selection, clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, and device use training , trial enrollment and other work, until the clinical trial is completed and the report is issued
Registration declaration

Review time

5

90

The product registration inspection report/entrusted inspection report/clinical trial report is declared within 2 weeks after obtaining the registration information, and the registration information is prepared for printing, stamping and scanning. Confirm, sort out and report, and obtain the product acceptance notice, and notify the enterprise that needs to pay the fee to pay the fee (if any), and then enter the review stage
System assessment report
10

After the system documents are completed and pass the preliminary acceptance of Party B, the system assessment will be submitted within 10 working days after the registration application, and the preparation and guidance of the system assessment application materials will be completed, and the internal audit and pre-audit will be completed.
Registration and supplement

Review time

Correction period of 12 months

60

Waiting for registration and supplementation Assist in the improvement of registration and supplementary materials, and pre-examination of application for supplementary materials if conditions permit
Registration approval
20

The approval time of the drug regulatory department is waiting for the approval document to be issued
Obtain a certificate of registration
10

Waiting for evidence collection to receive product registration approval