Huaguang Taihe provides import registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, preparation and review of registration materials, translation of Chinese and English documents, impartial guidance, declaration and tracking, etc., registration and other important links, for product entry China market access provides full service.

  Service Content

1. Guidance and services for technical requirements writing of registered products (Chinese);

2. Registered product risk management report writing and counseling services (Chinese);

3. Safe and effective checklist, summary data writing as counseling service (Chinese)

4. Research materials, including product validity verification, sterilization verification, packaging and transportation verification and other counseling services;

5. Clinical evaluation report of exempted products, writing of clinical comparison data of the same variety, and counseling services (Chinese);

6. Register for other document writing and tutoring services (Chinese);

7. Submission of product registration materials and receipt of registration certificates (Chinese);

8. Arrangement of country of origin documents, announcement and guidance services.

  Prepare materials

1. The product manual is provided (in Chinese) (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. The certification document issued by the medical device authority of the country (region) where the overseas registrant is located to allow the market to be sold;

4. A copy of the power of attorney, the letter of commitment of the agent and the copy of the business license of the overseas registrant to formulate an agent in China;

5. Compare and contrast product information, such as instructions, technical requirements, product registration certificates, etc., compare and contrast product information;

6. Power of Attorney;

7. Chinese and English translations, original documents of the country of origin.

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 source, resource and other information
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
30-60

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. 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

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. Confirm, sort out and report, and obtain the product acceptance notice, and notify the enterprise that needs to pay the fee to enter the review stage after paying the fee
Registration and supplement

Submit for review

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 Details

Huaguang Taihe provides import registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, preparation and review of registration materials, translation of Chinese and English documents, impartial guidance, declaration and tracking, etc., registration and other important links, for product entry China market access provides full service.

  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, summary data writing and counseling services;

3. Analysis performance evaluation, stability research, positive judgment value or reference interval value determination data writing and service;

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

5. Register for other document writing and tutoring services;

6. Submission of product registration materials and collection of registration certificates.

  Prepare materials

1. The product manual is provided (in Chinese) (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, the main raw material research materials, etc.);

3. The certification document issued by the medical device authority of the country (region) where the overseas registrant is located to allow the market to be sold;

4. A copy of the power of attorney, the letter of commitment of the agent and the copy of the business license of the overseas registrant to formulate an agent in China;

5. Compare and contrast product information, such as manuals, technical requirements, product registration certificates, etc.

6. Power of Attorney;

7. Chinese and English translations, original documents of the country of origin.

Service workflow and cycle

project

time/working day

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 the basic information of customers, including organizational structure, system coverage, system documents, main product process, main material sources, resources and other information

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 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

30-60
Finalize the product technical requirements and instructions, prepare to seal the product technical requirements and instructions, confirm the functional modules and clinical application scope, and express them to Party B

Party B is responsible for screening inspection agencies and sending them to the inspection institute for pre-examination, as well as entrusting inspection after pre-examination, inspection tracking, and finally obtaining the inspection report

Prepare product registration information and verification information to meet application requirements

30
The technical staff assists in the preparation of product application materials, and submits the product application technology to Party B for improvement and review, and revises and improves according to Party B's review comments, and prepares a clinical evaluation report

The product registration information is initially prepared according to the product characteristics and then submitted to Party A's technical staff for improvement, reviewing the documents provided by Party A and putting forward rectification opinions, and reviewing 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 protocols, determination of clinical institutions, protocol discussions, approval of ethics committees, training on device use, trial enrollment, etc.

Assist in institution selection, clinical trial protocol, clinical institution determination, protocol discussion, ethics approval, device use training, trial enrollment, etc., until the clinical trial is completed and a 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 information, and the registration information should be printed, stamped and scanned. After submitting the information, the fee will be paid as required, and the review stage

Completing the preparation of registration materials, and after confirmation by the company, sorting and reporting, and obtaining the product acceptance notice, the company will enter the review stage after payment is required.

Registration and supplement

Submit for review

Correction period of 12 months 60
waiting for registration

Assist in the improvement of registration and supplementary materials, and pre-examination of conditional application for supplementary materials

Registration approval

20
Drug Administration approval time

Waiting for approval to be issued

Obtain a certificate of registration

10
waiting for evidence

Receive product registration approval

 

Service Details

Huaguang Taihe provides import registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, preparation and review of registration materials, translation of Chinese and English documents, impartial guidance, declaration and tracking, etc., registration and other important links, for product entry China market access provides full service.

  Service Content

1. Guidance and services for technical requirements writing of registered products (Chinese);

2. Registered product risk management report writing and counseling services (Chinese);

3. Safe and effective checklist, summary data writing as counseling service (Chinese)

4. Research materials, including product validity verification, sterilization verification, packaging and transportation verification and other counseling services;

5. Clinical evaluation report of exempted products, writing of clinical comparison data of the same variety, and counseling services (Chinese);

6. Register for other document writing and tutoring services (Chinese);

7. Submission of product registration materials and receipt of registration certificates (Chinese);

8. Arrangement of country of origin documents, announcement and guidance services.

  Prepare materials

1. The product manual is provided (in Chinese) (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. The certification document issued by the medical device authority of the country (region) where the overseas registrant is located to allow the market to be sold;

4. A copy of the power of attorney, the letter of commitment of the agent and the copy of the business license of the overseas registrant to formulate an agent in China;

5. Compare and contrast product information, such as instructions, technical requirements, product registration certificates, etc., compare and contrast product information;

6. Power of Attorney;

7. Chinese and English translations, original documents of the country of origin.

Service workflow and cycle

project

time/working day

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 the basic information of customers, including organizational structure, system coverage, system documents, main product process, main material sources, resources and other information

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 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

30-45 EMC/biocompatibility will extend
Finalize the product technical requirements and instructions, prepare to seal the product technical requirements and instructions, confirm the functional modules and clinical application scope, and express them to Party B

Party B is responsible for screening inspection agencies and sending them to the National Inspection Institute for pre-examination, as well as entrusting inspection after pre-examination, inspection tracking, and finally obtaining the inspection report

Prepare product registration information and verification information to meet application requirements

30
The technical staff assists in the preparation of product application materials, and submits the product application technology to Party B for improvement and review, and revises and improves according to Party B's review comments, and prepares a clinical evaluation report

The product registration information is initially prepared according to the product characteristics and then submitted to Party A's technical staff for improvement, reviewing the documents provided by Party A and putting forward rectification opinions, and reviewing 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 protocols, determination of clinical institutions, protocol discussions, approval of ethics committees, training on device use, trial enrollment, etc.

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

Registration declaration

Review time

5 90
The product registration inspection report/entrusted inspection report/clinical trial report should be declared within 2 weeks after obtaining the registration information, and the registration information should be printed, stamped and scanned. After submitting the information, the fee will be paid as required, and the review stage

Completing the preparation of registration materials, and after confirmation by the enterprise, sorting and reporting, and obtaining a product acceptance notice, and notifying the enterprise to pay the fee (if any), it will enter the review stage

Registration and supplement

Correction period of 12 months 60
waiting for registration

Assist in the improvement of registration and supplementary materials, and pre-examination of conditional application for supplementary materials

Registration approval

20
Drug Administration approval time

Waiting for approval to be issued

Obtain a certificate of registration

10
waiting for evidence

Receive product registration approval

 

Service Details

Huaguang Taihe provides import registration services for medical device enterprises, assisting enterprises in the preparation of product technical requirements, product testing, preparation and review of registration materials, translation of Chinese and English documents, impartial guidance, declaration and tracking, etc., registration and other important links, for product entry China market access provides full service.

  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, summary data writing and counseling services;

3. Analysis performance evaluation, stability research, positive judgment value or reference interval value determination data writing and service;

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

5. Register for other document writing and tutoring services;

6. Submission of product registration materials and collection of registration certificates.

  Prepare materials

1. The product manual is provided (in Chinese) (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) specific production process of main components, raw material research materials, etc.);

3. The certification document issued by the medical device authority of the country (region) where the overseas registrant is located to allow the market to be sold;

4. A copy of the power of attorney, the letter of commitment of the agent and the copy of the business license of the overseas registrant to formulate an agent in China;

5. Compare and contrast product information, such as manuals, technical requirements, product registration certificates, etc.

6. Power of Attorney;

7. Chinese and English translations, original documents of the country of origin.

Service workflow and cycle

project

time/working day

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 the basic information of customers, including organizational structure, system coverage, system documents, main product process, main material sources, resources and other information

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 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

30-45

Finalize the product technical requirements and instructions, prepare to seal the product technical requirements and instructions, confirm the functional modules and clinical application scope, and express them to Party B

Party B is responsible for screening inspection agencies and sending them to the National Inspection Institute for pre-examination, as well as entrusting inspection after pre-examination, inspection tracking, and finally obtaining the inspection report

Prepare product registration information and verification information to meet application requirements

30

The technical staff assists in the preparation of product application materials, and submits the product application technology to Party B for improvement and review, and revises and improves according to Party B's review comments, and prepares a clinical evaluation report

The product registration information is initially prepared according to the product characteristics and then submitted to Party A's technical staff for improvement, reviewing the documents provided by Party A and putting forward rectification opinions, and reviewing 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 protocols, determination of clinical institutions, protocol discussions, approval of ethics committees, training on device use, trial enrollment, etc.

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

Registration declaration

Review time

5

90

The product registration inspection report/entrusted inspection report/clinical trial report should be declared within 2 weeks after obtaining the registration information, and the registration information should be printed, stamped and scanned. After submitting the information, the fee will be paid as required, and the review stage

Completing the preparation of registration materials, and after confirmation by the enterprise, sorting and reporting, and obtaining a product acceptance notice, and notifying the enterprise to pay the fee (if any), it will enter the review stage

Registration and supplement

Submit for review

Correction period of 12 months

60

waiting for registration

Assist in the improvement of registration and supplementary materials, and pre-examination of conditional application for supplementary materials

Registration approval

20

Drug Administration approval time

Waiting for approval to be issued

Obtain a certificate of registration

10

waiting for evidence

Receive product registration approval