Measures for the Supervision and Administration of Medical Device Production (Revised in 2017)
Measures for the Supervision and Administration of Medical Device Production (Revised in 2017)
Measures for the Supervision and Administration of Medical Device Production (Revised in 2017)
Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated under the Order of the China Food and Drug Administration No.7 on July 30, 2014, and amended under the Decision on Revising Some Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 For the purpose of strengthening supervision and administration of medical device production, regulating practices of manufacturing medical devices, and ensuring medical devices are safe and effective, these Measures are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices.
Article 2 Undertaking activities to manufacture medical devices within the territory of the People's Republic of China, as well as supervising such activities, shall comply with the present Measures.
Article 3 The China Food and Drug Administration shall be responsible for supervision and administration of the medical device production nationwide. Food and drug administrators at or above the county level shall be responsible for supervision and administration of the medical device production within the local administrative region.
Food and drug administrators at the higher level shall give guidance to and supervise subordinate food and drug administrators to conduct supervision and administration of medical device production.
Article 4 The China Food and Drug Administration shall enact the quality management standards on medical device production and supervise the implementation thereof.
Article 5 Food and drug administrators shall publish information about the licensing and record-filing of the medical device production in a legal and timely manner. An applicant may check the progress and result of the examination and approval; and the general public is provided with access to results of the examination and approval.
Article 6 A medical device manufacturer shall bear responsibility for the quality of medical devices it manufactures. Where the manufacturing is entrusted to another party, the entrusting party shall bear responsibility for the quality of medical devices manufactured on a commission basis.
Chapter II Administration of Manufacturing by Licensing and Record-filing
Article 7 Any entity that intends to manufacture medical devices shall satisfy all of the following requirements.
1. Having in place production sites, environmental conditions, manufacturing equipment and professional personnel, suitable for medical devices it manufactures;
2. Having established the organization for inspecting the quality of medical devices it manufactures, or specific inspectors and inspecting equipment for this purpose;
3. Having laid down management systems on the quality of medical devices;
4. Having the capacity for after-sales services suitable for medical devices it manufactures; and
5. Meeting requirements established in documents in respect of the product research and development and the production techniques.
Article 8 To establish a Class II or Class III medical device manufacturer, an application shall be filed to the food and drug administrator of the local province, autonomous region or municipality directly under the Central Government for a production license by submitting the following materials,
1. A photocopy of its business license;
2. Photocopies of the manufactured medical devices' registration certificate held by the applicant and the technical requirements of such medical devices;
3. Photocopies of the identification of the applicant's legal representative and the person in charge of the enterprise;
4. Photocopies of identifications, education background and professional titles of the production head, the quality head, and the technical head;
5. List of the education background and professional titles of all practitioners taking up posts of production management and quality inspection;
6. Documentary evidence for production sites; where there are special requirements on the production environment, photocopies of supporting documents for facilities and the environment shall be submitted as well;
7. Catalog of major manufacturing equipment and inspecting equipment;
8. Quality Manuals and procedural documents;
9. Process flowchart;
10. The proof of authorization granted to the person who handles the said application; and
11. Other documentary evidence.
Article 9 Upon receipt of an application, the food and drug administrator of each province, autonomous region or municipality directly under the Central Government shall deal with the application differently under the following circumstances,
1. Where items applied fall within its authority and application materials provided are complete and in the statutory forms, it shall accept the application;
2. Where application materials provided are incomplete or not in the statutory forms, it shall inform the applicant of all materials to be supplemented at one time either on the spot or within five working days. If it fails to do so, it shall be deemed to have accepted the application from the date of receiving the application materials;
3. Where it is possible to correct any error on the application materials on the spot, it shall allow the applicant to make correction on the spot; and
4. Where any item applied is beyond its authority, it shall decide not to accept the application promptly and notify the applicant of filing an application to the related administrative organ.
The food and drug administrator of each province, autonomous region or municipality directly under the Central Government, despite its acceptance of or refusal to the application for a license for medical device production, shall issue a written notice on its acceptance of or refusal to the application.
Article 10 The food and drug administrator of a province, autonomous region and municipality directly under the Central Government shall, within 30 working days as of the date of acceptance, examine the application materials, and verify relevant particulars on the spot in accordance with the quality management standards on medical device production. The on-site verification shall be performed as the case may be, to avoid unnecessarily repeated examination. The timeframe for rectification, when necessary, will not be included into the examination period.
Where the application materials satisfy required conditions, it shall make a written decision to grant the licensing and issue a License for Medical Device Production within 10 working days to the applicant concerned; where the application materials fail to meet required conditions, it shall make a written decision to disapprove of the licensing and explain the reasons therefore.
Article 11 The establishment of a Class I manufacturer of medical devices requires filing a record for the manufacturing of Class I medical devices with the municipal food and drug administrator at the local city with districts by providing a photocopy of the record-filing certificate obtained by the manufacturer for the medical devices it will manufacture and those materials specified in Article 8 herein (excluding materials under Item 2).
The food and drug administrator shall examine on the spot whether materials submitted by the enterprise are complete, and process the record-filing if the given requirements are met and issue the record-filing certificate for the manufacturing of Class I medical devices.
Article 12 Where the application for a license for medical device production directly relates to major interests between the applicant and others, the food and drug administrator shall inform the applicant and interested parties of their rights to apply for a hearing in accordance with laws, regulations and relevant provisions of the CFDA; while examining the application for a license for medical device production, the food and drug administrator, if it holds that the major licensing items concern public interests, shall release relevant information to the public and hold a hearing.
Article 13 The License for Medical Device Production shall be valid for five years and specify the serial number of the License, corporate name, its legal representative, person in charge, domicile, production address, production scope, issuer of the License, date of issue, date of expiration and other information.
The product registration form for medical device production, affixed to a License for Medical Device Production will clearly specify the name of products to be manufactured, the registration number thereof, and other relevant information.
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Order of the China Food and Drug Administration No.37
November 17, 2017
(Promulgated under the Order of the China Food and Drug Administration No.7 on July 30, 2014, and amended under the Decision on Revising Some Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Chapter I General Provisions
Article 1 For the purpose of strengthening supervision and administration of medical device production, regulating practices of manufacturing medical devices, and ensuring medical devices are safe and effective, these Measures are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices.
Article 2 Undertaking activities to manufacture medical devices within the territory of the People's Republic of China, as well as supervising such activities, shall comply with the present Measures.
Article 3 The China Food and Drug Administration shall be responsible for supervision and administration of the medical device production nationwide. Food and drug administrators at or above the county level shall be responsible for supervision and administration of the medical device production within the local administrative region.
Food and drug administrators at the higher level shall give guidance to and supervise subordinate food and drug administrators to conduct supervision and administration of medical device production.
Article 4 The China Food and Drug Administration shall enact the quality management standards on medical device production and supervise the implementation thereof.
Article 5 Food and drug administrators shall publish information about the licensing and record-filing of the medical device production in a legal and timely manner. An applicant may check the progress and result of the examination and approval; and the general public is provided with access to results of the examination and approval.
Article 6 A medical device manufacturer shall bear responsibility for the quality of medical devices it manufactures. Where the manufacturing is entrusted to another party, the entrusting party shall bear responsibility for the quality of medical devices manufactured on a commission basis.
Chapter II Administration of Manufacturing by Licensing and Record-filing
Article 7 Any entity that intends to manufacture medical devices shall satisfy all of the following requirements.
1. Having in place production sites, environmental conditions, manufacturing equipment and professional personnel, suitable for medical devices it manufactures;
2. Having established the organization for inspecting the quality of medical devices it manufactures, or specific inspectors and inspecting equipment for this purpose;
3. Having laid down management systems on the quality of medical devices;
4. Having the capacity for after-sales services suitable for medical devices it manufactures; and
5. Meeting requirements established in documents in respect of the product research and development and the production techniques.
Article 8 To establish a Class II or Class III medical device manufacturer, an application shall be filed to the food and drug administrator of the local province, autonomous region or municipality directly under the Central Government for a production license by submitting the following materials,
1. A photocopy of its business license;
2. Photocopies of the manufactured medical devices' registration certificate held by the applicant and the technical requirements of such medical devices;
3. Photocopies of the identification of the applicant's legal representative and the person in charge of the enterprise;
4. Photocopies of identifications, education background and professional titles of the production head, the quality head, and the technical head;
5. List of the education background and professional titles of all practitioners taking up posts of production management and quality inspection;
6. Documentary evidence for production sites; where there are special requirements on the production environment, photocopies of supporting documents for facilities and the environment shall be submitted as well;
7. Catalog of major manufacturing equipment and inspecting equipment;
8. Quality Manuals and procedural documents;
9. Process flowchart;
10. The proof of authorization granted to the person who handles the said application; and
11. Other documentary evidence.
Article 9 Upon receipt of an application, the food and drug administrator of each province, autonomous region or municipality directly under the Central Government shall deal with the application differently under the following circumstances,
1. Where items applied fall within its authority and application materials provided are complete and in the statutory forms, it shall accept the application;
2. Where application materials provided are incomplete or not in the statutory forms, it shall inform the applicant of all materials to be supplemented at one time either on the spot or within five working days. If it fails to do so, it shall be deemed to have accepted the application from the date of receiving the application materials;
3. Where it is possible to correct any error on the application materials on the spot, it shall allow the applicant to make correction on the spot; and
4. Where any item applied is beyond its authority, it shall decide not to accept the application promptly and notify the applicant of filing an application to the related administrative organ.
The food and drug administrator of each province, autonomous region or municipality directly under the Central Government, despite its acceptance of or refusal to the application for a license for medical device production, shall issue a written notice on its acceptance of or refusal to the application.
Article 10 The food and drug administrator of a province, autonomous region and municipality directly under the Central Government shall, within 30 working days as of the date of acceptance, examine the application materials, and verify relevant particulars on the spot in accordance with the quality management standards on medical device production. The on-site verification shall be performed as the case may be, to avoid unnecessarily repeated examination. The timeframe for rectification, when necessary, will not be included into the examination period.
Where the application materials satisfy required conditions, it shall make a written decision to grant the licensing and issue a License for Medical Device Production within 10 working days to the applicant concerned; where the application materials fail to meet required conditions, it shall make a written decision to disapprove of the licensing and explain the reasons therefore.
Article 11 The establishment of a Class I manufacturer of medical devices requires filing a record for the manufacturing of Class I medical devices with the municipal food and drug administrator at the local city with districts by providing a photocopy of the record-filing certificate obtained by the manufacturer for the medical devices it will manufacture and those materials specified in Article 8 herein (excluding materials under Item 2).
The food and drug administrator shall examine on the spot whether materials submitted by the enterprise are complete, and process the record-filing if the given requirements are met and issue the record-filing certificate for the manufacturing of Class I medical devices.
Article 12 Where the application for a license for medical device production directly relates to major interests between the applicant and others, the food and drug administrator shall inform the applicant and interested parties of their rights to apply for a hearing in accordance with laws, regulations and relevant provisions of the CFDA; while examining the application for a license for medical device production, the food and drug administrator, if it holds that the major licensing items concern public interests, shall release relevant information to the public and hold a hearing.
Article 13 The License for Medical Device Production shall be valid for five years and specify the serial number of the License, corporate name, its legal representative, person in charge, domicile, production address, production scope, issuer of the License, date of issue, date of expiration and other information.
The product registration form for medical device production, affixed to a License for Medical Device Production will clearly specify the name of products to be manufactured, the registration number thereof, and other relevant information.
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