EN 
first-class filing
- Product description
- Domestic first-class product filing
- Record of imported first-class products
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- Commodity name: first-class filing
- Commodity ID: 03
Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal procedures to decide whether to approve their sales and use. It is divided into domestic medical device registration and overseas medical device registration. Whether overseas medical devices are Class I, Class II, or Class III, they must go to the State Drug Administration; domestic Class I and Class II medical devices are registered in the local province or city. Food and Drug Administration for handling, three categories to the State Drug Administration for handling. Medical device registration certificate refers to the legal identity card of medical device products. After obtaining the registration certificate, apply for the production license, and only after obtaining the production license can the product be marketed.
The state encourages the implementation of the registrant system, that is, the production of medical devices can be entrusted to companies with production conditions without geographical restrictions. Different provinces and cities have also issued corresponding policies, and the local requirements are different, which provides the necessary conditions for the commissioned production of medical devices. Convenient regulatory basis.
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.
For domestic Class I medical device filing, the filing person submits filing materials to the food and drug administration at the districted city level. For the filing of imported Class I medical devices, the filing person submits filing materials to the State Food and Drug Administration. The filing of medical devices in Hong Kong, Macau and Taiwan shall be handled with reference to imported medical devices.
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Service Content
1. Recording product technical requirements writing guidance and services;
2. Record product risk management report writing and counseling services;
3. Recording product clinical evaluation report writing and counseling services;
4. Record other document writing and counseling services;
5. Submission of product filing materials and collection of filing 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. Power of Attorney.
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
resource assessment
2
The customer provides the basic information of the company and products, including company qualification, product information, production process, environment, facilities and equipment, supplier information, etc.
Understand the basic information of customers, including organizational structure, system coverage, system construction, personnel, main product process, main material sources, resources and other information
Prepare product technical requirements and product manuals
2
Product basic data, functional information, structural composition, clinical application scope, design basis, product operating instructions and other technical documents
Provide technical requirements templates, review the compliance of product technical requirements and specifications, and determine compliance with filing requirements
Product self-test report
1
EMC/biocompatibility may be extended
Finalize product technical requirements and instructions, prepare stamped product technical requirements and instructions, and prepare product inspection reports according to technical requirements
Party B is responsible for compiling the report template, and checking whether Party A's filling is complete according to the template, and needs the assistance of external inspection.
Prepare product filing materials
30
Technical personnel assist in the preparation of product declaration materials and provide corresponding basic information,
Assist in the preparation of risk management reports, clinical evaluation data and other filing requirements to meet the application requirements
filing declaration
approve the time
the day
uncertain
Prepare the product filing materials, print and stamp them, submit them to Party B for upload, and wait for approval. The filing certificate can be obtained on the same day as required by regulations, but the requirements vary from place to place, so be patient.
Organize and report the materials, upload the scanned copy of the stamp to the supervisory department, and track the progress of the filing. If the modification is required, complete the modification in time, and receive the filing certificate in time after approval.
Production record
approve the time
2
uncertain
Prepare the production record data, print and stamp it, submit it to Party B for upload, and wait for approval. The regulations require that the record certificate can be obtained on the same day, but the requirements of each place are different, please wait patiently
Organize and report the materials, upload the scanned copy of the stamp to the supervisory department, and track the progress of the filing. If the modification is required, complete the modification in time, and receive the filing certificate in time after approval.
System audit
within 3 months
Prepare system assessment materials and meet system audits. Regulations stipulate that after a class of products obtain a production record certificate, the regulatory department will conduct daily system audits within 3 months
Coaching to prepare system assessment materials (if agreed in the contract), training related system and regulatory requirements, and preliminary review of system assessment materials
daily system maintenance
irregular
Continue to improve according to the initially established system and ensure effective operation
Regular training, coaching, inspections (if contractually agreed) to ensure compliance with regulatory requirements
project closing
2
Receive and organize filing materials
Submit the filing materials to Party A. If there is no other agreement, the project will be completed successfully
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Service Content
1. Guidance and services for filing technical requirements of products (Chinese);
2. Recording product risk management report writing and counseling services (Chinese);
3. Compilation of clinical evaluation reports and counseling services for registered products (Chinese);
4. Record other document writing and tutoring services (Chinese);
5. Submission of product filing materials and receipt of filing certificates (Chinese).
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 competent medical device authority of the country (region) where the overseas filer is located to allow the market to be sold;
4. Copies of the power of attorney, the letter of commitment of the agent and the copy of the business license of the foreign filing person to formulate an agent in China;
5. Power of Attorney;
6. 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
resource assessment
2
The customer provides the basic information of the company and products, including company qualification, product information, production process, environment, facilities and equipment, supplier information, etc.
Understand the basic information of customers, including organizational structure, system coverage, system construction, personnel, main product process, main material sources, resources and other information
Prepare product technical requirements and product manuals
2
Product basic data, functional information, structural composition, clinical application scope, design basis, product operating instructions and other technical documents
Provide technical requirements templates, review the compliance of product technical requirements and specifications, and determine compliance with filing requirements
Product self-test report
1
EMC/biocompatibility may be extended
Finalize product technical requirements and instructions, prepare stamped product technical requirements and instructions, and prepare product inspection reports according to technical requirements
Party B is responsible for compiling the report template, and checking whether Party A's filling is complete according to the template, and needs the assistance of external inspection.
Prepare product filing materials
30
Technical personnel assist in the preparation of product declaration materials and provide corresponding basic information,
Assist in the preparation of risk management reports, clinical evaluation data and other filing requirements to meet the application requirements
Translation of filing documents
approve the time
10
the day
After Party B completes the document review, translate the Chinese documents into English
Organize the filing materials to ensure that they meet the filing requirements, and hand over the documents that Party A will need to submit in English
Fairness of overseas listing documents
10
Party A sends the country of origin approval documents and necessary translation documents to the country of origin for fairness
Confirm that a fair document is required, and hand it over to Party A for fairness
Product filing
approve the time
2
the day
Scan the electronic version of the fair document and send the electronic version to Party B, who is responsible for
Organize and report the materials, upload the scanned copy of the stamp to the supervisory department, and track the progress of the filing. If the modification is required, complete the modification in time, and receive the filing certificate in time after approval.
project closing
2
Receive and organize filing materials
Submit the filing materials to Party A. If there is no other agreement, the project will be completed successfully
Connection
Address：513，5th floor， building 12, courtyard 5, Tianhua street, Daxing District, Beijing
Telephone：400 892 8618 E-mail：chenjianjun@medadmt.com
Copyright：Beijing Huaguang Taihe Medical Technology Service Co., Ltd