Supervision and management of medical device production Article 1 In order to strengthen the supervision and management of medical device production, standardize the production of medical devices, to ensure the safety and effectiveness of medical devices, according to the "Supervision and Management of Medical Devices Regulations", the formulation of these measures.
The second in the Chinese people *** and the country engaged in the production of medical devices and its supervision and management, shall comply with these measures.
Article 3 The State Food and Drug Administration is responsible for the supervision and management of the national medical device production. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of the production of medical devices in the administrative region.
Superior food and drug supervision and management departments are responsible for guiding and supervising the lower food and drug supervision and management departments to carry out supervision and management of medical device production.
Article 4 The State Food and Drug Administration formulates and supervises the implementation of quality management standards for the production of medical devices.
Article 5 The food and drug supervision and management departments in accordance with the law and timely release of medical device production licensing and filing of relevant information. Applicants can inquire about the progress of approval and approval results; the public can access the approval results.
Article VI of the medical device manufacturer shall be responsible for the production of medical devices quality. Commissioned the production, the commissioning party is responsible for the commissioned production of medical devices quality. Article VII engaged in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel;
(b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
(c) have to ensure that the quality of medical devices Management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements.
Article VIII of the second class, the third class of medical device manufacturer shall apply to the local province, autonomous region, municipality directly under the Central Food and Drug Administration for permission to produce, and submit the following information:
(a) business license, organization code certificate copy;
(b) the applicant holds the production of medical devices and product registration certificate and product technology requirement Copy;
(C) legal representative, a copy of the identity of the person in charge of the enterprise;
(D) production, quality and technical personnel in charge of the identity of the person, academic qualifications, titles;
(E) production and management, quality inspection positions of practitioners in the academic qualifications, titles list;
(F) the production site of the supporting documents, there are special production environment Requirements should also be submitted to the facilities, environment, copies of documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the person in charge;
(xi) other supporting information.
Article IX Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, upon receipt of the application, according to the following circumstances:
(a) the application is within its terms of reference, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not comply with the statutory form, the applicant shall be informed of the need to fill in the application within five working days on the spot or at once. (b) the application information is incomplete or does not meet the statutory form, the applicant shall be informed of all the contents of the need to make corrections within five working days at a time, late notification, since the date of receipt of the application information shall be accepted;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, it shall be immediate inadmissibility of the decision, and inform the applicant to the The relevant administrative departments to apply.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to accept or reject the application for authorization of the production of medical devices, shall issue a notice of acceptance or inadmissibility.
Article X Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, within 30 working days from the date of acceptance of the application information for review, and in accordance with the requirements of the quality management standard for the production of medical devices to carry out on-site verification. On-site verification should be based on the situation, to avoid duplication of verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "Medical Device Manufacturing License"; does not meet the prescribed conditions, to make a written decision not to permit, and explain the reasons.
Article XI of the first class of medical equipment manufacturers, should be located in the municipal food and drug supervision and management department for the first class of medical equipment production record, submit a copy of the filing of the record enterprise held by the production of medical devices for the record vouchers and the information provided for in Article 8 of these measures (except for the second item).
The food and drug supervision and management department shall be on the spot on the integrity of the information submitted by the enterprise to check, in line with the prescribed conditions to be filed, issued by the first class of medical devices production filing voucher.
Article XII of the medical device production license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of the medical device production license, the food and drug supervision and management department believes that involves public **** interests of significant licenses. Public **** interests of major licensing matters, shall be announced to the community, and hold a hearing.
Article XIII of the "Medical Device Manufacturing License" is valid for five years, set forth the license number, enterprise name, legal representative, responsible person, residence, production address, production range, the licensing department, the date of issuance and validity period and other matters.
"Medical Device Manufacturing License" attached to the production of medical devices product registration form, containing the name of the production product, registration number and other information.
Article XIV increase in the production of products, medical device manufacturers should be submitted to the original licensing department in the provisions of Article VIII of these measures involves changes in the content of the relevant information.
Apply to increase the production of products does not belong to the original scope of production, the original licensing department shall, in accordance with the provisions of Article 10 of the review and carry out on-site verification, in line with the prescribed conditions, change the "Medical Device Manufacturing License" set out in the scope of production, and in the production of medical equipment product registration form in the registration of product information.
Apply to increase the production of products belonging to the original scope of production, and with the original license to produce products of the production process and production conditions and other requirements similar to the original licensing department shall be declared to audit the information, meet the prescribed conditions, in the production of medical devices in the product registration form of the product information; and with the original license to produce products of the production process and the production conditions of the requirements of the material difference, shall be in accordance with the provisions of Article 10 of the Measures for review and verification and carry out on-site verification. Measures to review the provisions of Article X and carry out on-site verification, meet the prescribed conditions, in the medical device production product registration form to register product information.
Article XV of the production of non-textual changes in the address, shall apply to the original licensing department to change the production of medical devices license, and submit the provisions of Article 8 of these Measures involves changes in the content of the relevant information. The original licensing department shall, in accordance with the provisions of Article X of these measures to review and carry out on-site verification, within 30 working days to make the decision to grant the change or not change. Medical device manufacturers across provinces, autonomous regions and municipalities directly under the Central Government to set up production sites, should apply for a separate medical device production license.
Article XVI of the enterprise name, legal representative, the person in charge of the enterprise, residence changes or textual changes in the production address, medical device manufacturers should be changed within 30 working days after the change to the original licensing department for the "Medical Device Manufacturing License" to change the registration and submit the relevant departments of the supporting information. The original licensing department shall promptly handle the change. The change of information is incomplete or does not meet the formal review of the provisions, should be informed of the need to make corrections to all the contents at once.
Article XVII of the "Medical Device Manufacturing License" expiration of the continuation of the medical device manufacturers should be valid since the expiration of six months before the original licensing department for the continuation of the "Medical Device Manufacturing License" application.
The original licensing department shall, in accordance with the provisions of Article 10 of the continuation of the application for review, on-site verification, if necessary, in the "Medical Device Manufacturing License" before the expiration of the validity of the decision on whether to grant the continuation. Meet the prescribed conditions, the continuation is granted. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Failure to make a decision after the deadline, deemed to be granted continuation.
Article XVIII due to the separation, merger and survival of medical device manufacturers, shall apply for a change of license in accordance with the provisions of these measures; due to the separation of enterprises, mergers and dissolution of medical device manufacturers, shall apply for cancellation of the "Medical Device Manufacturing License"; due to the separation of enterprises, the merger of the newly established medical device manufacturers shall apply for the "Medical Device Manufacturing License".
Article 19 of the "medical device production license" lost, medical device manufacturers should immediately in the original licensing department designated by the media to publish a statement of loss. Since the date of publication of the statement of loss of 1 month, to the original licensing department to apply for reissue. The original licensing department in a timely manner to reissue the "medical device manufacturing license".
Article XX changes, reissued "medical device production license" number and validity period remains unchanged. Renewal of the "medical device production license" number unchanged.
Article 21 of the first class of medical devices production record certificate changes in content, should be changed for the record.
Filing credentials lost, medical device manufacturers should be timely to the original record department for replacement procedures.
Article 22 of the production of medical devices due to illegal production of food and drug supervision and management department of the investigation has not yet been closed, or received an administrative penalty decision but has not yet been fulfilled, the food and drug supervision and management department shall suspend the license until the case is completed.
Article 23 of the medical device manufacturers have laws and regulations should be canceled circumstances, or the validity period has not expired but the company took the initiative to cancel, the provinces, autonomous regions and municipalities directly under the central food and drug supervision and management departments shall be canceled according to law, "Medical Device Manufacturing License", and be published on the website.
Article 24 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall establish the "medical device production license" issued, continuation, change, reissuance, revocation and cancellation of the license file.
Settlement of municipal food and drug supervision and management departments shall establish the first class of medical equipment production record information files.
Article 25 No unit or individual shall not forge, alter, buy, sell, lease, lend "medical device production license" and medical device production record vouchers. Article 26 The commissioned production of medical devices should be commissioned by the commissioning side of the production of medical devices in the territory of the registrant or filer. Among them, the commissioned production does not belong to the innovative medical devices in accordance with the special approval procedures for the approval of medical devices within the territory, the commissioning party shall obtain the commissioned production of medical devices production license or for the production of Class I medical devices for the record.
Medical devices commissioned by the production of the entrusted party shall be commissioned to produce medical devices to obtain the corresponding range of production licenses or for the production of Class I medical devices for the record in the territory of the manufacturer. The entrusted party to the entrusted production of medical equipment quality is responsible for the corresponding responsibility.
Article 27 The commissioning party shall provide the commissioned party to the production of medical devices commissioned by the quality management system documents and registered or filed product technical requirements, the commissioned party's production conditions, technical level and quality management capabilities to assess the commissioned party to confirm that the commissioned party has the conditions and capabilities of the commissioned production and production process and quality control to guide and supervise.
Article 28 The entrusted party shall organize the production in accordance with the quality management standards for the production of medical devices, mandatory standards, product technical requirements and entrusted production contract, and save all entrusted production documents and records.
Article 29 The commissioning party and the commissioned party shall sign the commissioned production contract, specify the rights, obligations and responsibilities of both parties.
Article 30 commissioned the production of Class II, Class III medical devices, the commissioning party shall be the location of the province, autonomous region, municipality directly under the central food and drug supervision and management department for the commissioned production for the record; commissioned the production of Class I medical devices, the commissioning party shall be the location of municipal food and drug supervision and management for the commissioning of the production for the record. Meet the prescribed conditions, the food and drug supervision and management department shall issue a medical device commissioned the production of the record voucher.
For the record should be submitted to the following information:
(a) commissioned the production of medical devices or a copy of the registration certificate for the record;
(b) the commissioning party and the entrusted party's business license and a copy of the organization code certificate;
(c) entrusted to the party's "Medical Device Manufacturing License" or a copy of the first class of medical devices production record certificate;
(iv) a copy of the commissioned production contract;
(v) proof of authorization by the operator.
Commissioned production is not in accordance with the innovative medical device special approval procedures for the approval of medical devices in the territory, should also be submitted to the commissioning party's "Medical Device Manufacturing License" or a copy of the first class of medical devices production filing vouchers; is in accordance with the innovation of medical devices in accordance with the approval procedures for the approval of medical devices in the territory, should be submitted to the innovation of medical devices to prove that the special approval of information.
Article 31 entrusted with the production of Class II, Class III medical devices, the entrusted party shall, in accordance with the provisions of Article 14 of these Measures to handle the relevant procedures in the production of medical devices in the product registration form for the production of entrusted product information.
Trusted production of Class I medical devices, the entrusted party shall, in accordance with the provisions of Article 21 of these Measures, to the original record department for the production of Class I medical devices for the record change.
Article 32 The entrusted party for the increase of entrusted production product information or the first class medical device production record changes, in addition to submitting the information in line with the provisions of these measures, the following information shall also be submitted:
(a) the commissioning party and the entrusted party's business license, a copy of the organization code certificate;
(b) entrusted to the "Medical Device Production License" or Class I medical device production record certificates;
(C) commissioned by the commissioning side of the medical device commissioned production record certificates;
(D) commissioned a copy of the production contract;
(E) commissioned the production of medical devices to be used in the instruction manuals and labeling samples;
(F) commissioning side of the commissioning party's quality management system of the statement of approval;
(vii) the commissioning party on the commissioning of the production of medical devices quality, sales and after-sales service responsibility of the self-assurance statement.
The commissioned production is not in accordance with the innovative medical device special approval procedures for the approval of medical devices in the territory, should also be submitted to the commissioning party's "Medical Device Manufacturing License" or a copy of the first class of medical devices production record certificate; is in accordance with the innovation of medical devices in accordance with the approval procedures for the approval of medical devices in the territory, should be submitted to the innovation of medical devices to prove that special approval of information.
Article 33 of the entrusted party "medical device production license" to produce product registration form and the first class of medical devices production record certificate of entrusted production of products should be indicated "entrusted to produce" and entrusted to the production period.
Article 34 commissioned the production of medical devices, in addition to instructions, labels should be in line with the relevant provisions, but also shall indicate the commissioned party's name, address, production address, production license number or production record certificate number.
Article 35 of the commissioned production termination, the commissioning party and the commissioned party shall be the location of the province, autonomous region, municipality directly under the central government or municipal food and drug supervision and management departments in a timely manner.
Article 36 The commissioning party in the same period of time can only be the same medical device products entrusted to a medical device manufacturer (except for the absolute control of the enterprise) for production.
Article 37 The implantable medical devices with high risk shall not be entrusted with the production, the specific catalog by the State Food and Drug Administration to develop, adjust and publish. Article 38 The medical device manufacturer shall, in accordance with the requirements of the quality management standard for the production of medical devices, the establishment of a quality management system and maintain effective operation.
Article 39 The medical device manufacturer shall carry out medical device laws, regulations, rules, standards and other knowledge training, and establish training files.
Production position operators should have the appropriate theoretical knowledge and practical skills.
Article 40 of the medical device manufacturer shall be registered or filed in accordance with the technical requirements of the product production organization, to ensure that the factory medical devices in line with mandatory standards and registered or filed by the technical requirements of the product. The medical device shall be qualified by the inspection and accompanied by qualified documents.
Article 41 The medical device manufacturer shall regularly in accordance with the requirements of the quality management standard for the production of medical devices quality management system for the operation of a comprehensive self-inspection, and at the end of each year to the location of the provinces, autonomous regions, municipalities directly under the Central Government or municipal food and drug supervision and management departments to submit an annual self-inspection report.
Article 42 of the medical device manufacturers of production conditions change, no longer meet the requirements of the quality management system for medical devices, medical device manufacturers shall immediately take corrective measures; may affect the safety and effectiveness of medical devices, shall immediately stop production activities, and to the county-level food and drug supervision and management department report.
Article 43 of the medical device products have been discontinued for more than one year and no similar products in production, production, medical device manufacturers shall report in advance in writing to the location of the province, autonomous region, municipality directly under the central government or municipal food and drug supervision and management department, after verification of compliance with the requirements before resuming production.
Article 44 of the medical device manufacturer does not have the original production license conditions or with the record information does not match, and can not be contacted, by the original licensing or filing department publicity, according to law, the cancellation of its "Medical Device Manufacturing License" or in the first class of medical devices production record information to be marked and announced to the community.
Article 45 The medical device manufacturer shall produce in the licensed or filed production site, the production equipment, process equipment and testing instruments and other facilities and equipment to maintain and ensure their normal operation.
Article 46 The medical device manufacturer shall strengthen the procurement management, establish a supplier audit system, supplier evaluation, to ensure that the procurement of products meet the statutory requirements.
Article 47 The medical device manufacturer shall record the procurement of raw materials, production, inspection and other processes. Records should be true, accurate and complete, and meet the requirements of traceability.
Article 48 The state encourages medical device manufacturers to use advanced technology to establish information management system.
Article 49 The production of medical devices manufacturer of medical devices in the event of a major quality incident, should be reported within 24 hours of the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration, the province, autonomous region, municipality directly under the Central Food and Drug Administration shall immediately report to the State Food and Drug Administration. Article 50 The food and drug supervision and management departments in accordance with the principles of risk management, the implementation of medical device production classification and grading management.
Article 51 Provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department shall prepare the administrative region of the medical device manufacturer supervision and inspection program, to determine the focus of medical device supervision, inspection frequency and coverage, and supervise the implementation.
Article 52 The supervision and inspection of medical device production shall check the implementation of laws, regulations, rules, norms, standards and other requirements of medical device manufacturers, focusing on the supervision and management of medical devices "Regulations" Article 53 of the matters specified.
Article 53 of the food and drug supervision and management department to organize supervision and inspection, shall develop inspection programs, clear inspection standards, factual records of on-site inspection, the results of the inspection in writing to the inspected enterprise. The need for rectification, should be clear rectification content and rectification period, and the implementation of tracking and inspection.
Article 54 The Food and Drug Administration shall strengthen the sampling and testing of medical devices.
Provincial food and drug supervision and management departments should be based on the conclusions of the sampling and inspection of medical devices issued in a timely manner quality announcement.
Article 55 of the complaint report or other information shows and daily supervision and inspection found that there may be product safety risks of medical device manufacturers, or have a record of bad behavior of medical device manufacturers, food and drug supervision and management departments can implement flight inspection.
Article 56 In one of the following cases, the food and drug supervision and management department can be the legal representative of the medical device manufacturer or the person in charge of the enterprise to carry out the responsibility of the interview:
(a) the production of the existence of serious safety hazards;
(b) the production of products due to the quality of the problem has been repeatedly reported to the police or complaints or media exposure;
(c) Credit rating is assessed as a bad credit enterprise;
(d) food and drug supervision and management department that it is necessary to carry out the responsibility of the other circumstances of the interview.
Article 57 The local food and drug supervision and management departments at all levels shall establish the administrative region of the medical device manufacturer's regulatory file. Supervision file shall include medical device manufacturer product registration and filing, production licensing and filing, commissioned production, supervision and inspection, sampling and testing, adverse event monitoring, product recall, malpractice records and complaints and reports and other information.
Article 58 The State Food and Drug Administration to establish a unified medical device production supervision and management information platform, the local food and drug supervision and management departments at all levels shall strengthen the construction of information technology to ensure that the information convergence.
Article 59 The local food and drug supervision and management departments at all levels should be based on the supervision and management of medical device manufacturers of relevant records, medical device manufacturers credit evaluation, the establishment of credit files. For enterprises with bad credit records, the frequency of inspection shall be increased.
The inclusion of "blacklisted" enterprises, in accordance with the relevant provisions of the State Food and Drug Administration.
Article 60 Individuals and organizations found that medical device manufacturers to illegal production activities, the right to report to the food and drug administration, food and drug supervision and management departments shall promptly verify and deal with. After verification, shall be rewarded in accordance with relevant provisions. Article 61 One of the following circumstances, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article 63 shall be punished:
(1) the production of medical devices without obtaining the certificate of registration of medical devices of the second class, the third class of medical devices;
(2) engaged in the production of medical devices of the second class, the third class of medical device production activities without permission;
(3) the production of medical devices that exceeds the scope of production or is related to the production of medical devices, the production of medical devices. Medical device production product registration form contained in the production of products inconsistent with the second class, the third class of medical devices;
(D) in the unauthorized production site production of second class, the third class of medical devices;
(E) second class, the third class of medical devices commissioned after the termination of the production of the entrusted party to continue to produce entrusted products.
Article 62 "Medical Device Manufacturing License" expires, not in accordance with the law for continuation, still continue to engage in the production of medical devices, in accordance with the "supervision and management of medical devices regulations" shall be punished in accordance with the provisions of Article 63.
Article 63 Provide false information or take other deceptive means to obtain a "medical device manufacturing license", in accordance with "supervision and management of medical equipment regulations" Article 64, paragraph 1, shall be punished.
Article 64 engaged in the production of Class I medical devices not in accordance with the provisions of the food and drug supervision and management department for the record, in accordance with the "Supervision and Management of Medical Devices Regulations" Article 65, paragraph 1, shall be punished; the record provides false information, in accordance with the "Supervision and Management of Medical Devices Regulations" Article 65, paragraph 2, shall be punished.
Article 65 of the forgery, alteration, trading, leasing, lending "medical device production license", in accordance with "Regulations for the Supervision and Management of Medical Devices" Article 64, paragraph 2, shall be punished.
Forgery, alteration, trading, leasing, lending of medical device production record certificate, by the food and drug supervision and management department at or above the county level shall order rectification and impose a fine of 10,000 yuan.
Article 66 One of the following circumstances, in accordance with the "supervision and management of medical devices regulations" Article 66 of the provisions of the penalty:
(a) the production of medical devices does not meet the mandatory standards or does not meet the technical requirements of the registered or filed products;
(b) medical device manufacturers do not follow the registered, filed product technical requirements for the organization of production
(c) entrusted to do not have the conditions set out in this approach to the production of medical devices or the entrusted party's production behavior management.
Article 67 of the medical device manufacturers of production conditions change, no longer meet the requirements of the quality management system for medical devices, not in accordance with the provisions of these measures to rectify, stop production, report, in accordance with the "supervision and management of medical devices regulations" Article 67 of the provisions of the penalty.
Article 68 of the medical device manufacturers are not in accordance with the provisions of the province, autonomous region, municipality directly under the Central Government or the municipal food and drug supervision and management department to submit the enterprise quality management system operation self-examination report, in accordance with the "supervision and management of medical devices regulations" Article 68 of the provisions of the penalty.
Article 69 One of the following circumstances, by the food and drug supervision and management department at or above the county level shall give a warning, ordered to make corrections within a certain period of time, and may impose a fine of 30,000 yuan or less:
(a) the factory medical equipment is not in accordance with the provisions of the test;
(b) the factory medical equipment is not in accordance with the provisions of the accompanying documents of conformity;
(c) the factory medical equipment is not in accordance with the provisions of Article 16 of the Regulations for the supervision and management of medical devices. In accordance with the provisions of Article XVI of these measures for "medical device manufacturing license" change registration;
(d) not in accordance with the provisions of the commissioned production for the record;
(e) medical device products discontinued for more than one year and no similar products in production, without the location of the provinces, autonomous regions, municipalities directly under the Central Government or municipal food and drug supervision and management departments to verify compliance with the requirements of resumed Production;
(F) to supervise and inspect the food and drug supervision and management departments to conceal the situation, provide false information or refuse to provide true information reflecting its activities.
The circumstances listed in the preceding paragraph, the situation is serious or cause harmful consequences, is a violation of the relevant provisions of the "Regulations for the Supervision and Administration of Medical Devices", in accordance with the "Regulations for the Supervision and Administration of Medical Devices" shall be punished. Article 70 The production of medical devices for export, should ensure that its production of medical devices in line with the requirements of the importing country (region), and product-related information to the location of the municipal food and drug supervision and management department for the record.
Producers to accept foreign enterprises entrusted to produce medical devices marketed and sold outside the country, shall obtain third-party certification of medical device quality management system or similar products within the production license or record.
Seventy-one "medical device production license" and the first class of medical devices production record voucher format by the State Food and Drug Administration unified development.
"Medical Device Manufacturing License" by the province, autonomous region, municipality directly under the Central Food and Drug Administration printed.
"Medical Device Manufacturing License" number is arranged in the following way: X Food and Drug Administration mechanical production Xu XXXXXXXXXX. Where:
The first X on behalf of the license department where the province, autonomous region, municipality directly under the central abbreviation; the second to five X on behalf of the 4-digit license year;
Sixth to ninth X on behalf of the 4-digit license number.
The first class of medical devices production record voucher record number is arranged in the following way: XX food and drug supervision and mechanical production of XXXXXXXXXXX. Where:
The first X on behalf of the filing department where the province, autonomous regions, municipalities directly under the Central Government for short;
The second X on behalf of the filing department is located in the district of the municipal administrative region for short;
The third to six X on behalf of the 4-digit filing year;
Seventh to ten X on behalf of the 4-digit filing water number.