Methods for the Administration of Registration of Medical Devices
(Reviewed and adopted by the Board Meeting of the State Food and Drug Administration on June 27, 2014, published on July 30, 2014, and effective since October 1, 2014) Article 1 In order to standardize the management of the registration and filing of medical devices and to ensure that the medical devices are safe and effective, according to the "Regulations for the Supervision and Administration of Medical Devices
Article 2 In the Chinese people *** and the territory of the sale, use of medical devices, shall apply for registration or filing in accordance with the provisions of these measures.
Article 3 The registration of medical devices is the food and drug supervision and management department in accordance with the application of the applicant for registration of medical devices, in accordance with the statutory procedures, the proposed listing of medical devices on the safety and efficacy of the research and its results of the systematic evaluation, in order to decide whether or not to agree to the process of its application. Medical device filing is the medical device filer to the food and drug administration to submit the record information, the food and drug administration of the filing information submitted to the archives for inspection.
Article 4 The registration and filing of medical devices shall follow the principles of openness, fairness and justice.
Article V Class I medical devices for the record management. Class II and Class III medical devices are subject to registration management. Within the first class of medical devices for the record, the filer to the municipal food and drug supervision and management department to submit the record information. Within the second class of medical devices by the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to review and approve the issuance of medical device registration certificate. Within the third class of medical devices by the State Food and Drug Administration for review, approval issued after the medical device registration certificate. Import of Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Import of Class II and Class III medical devices by the State Food and Drug Administration for examination, approval and issue of medical device registration certificate. Hong Kong, Macao, Taiwan, the registration of medical devices, the record, with reference to the import of medical devices.
Article VI of the medical device registrants, filers in their own name to market the product, the product is legally responsible.
Article VII Food and Drug Administration in accordance with the law and timely release of medical device registration, filing related information. Applicants can inquire about the progress and results of the approval, the public can access the results of the approval.
Article VIII The state encourages the research and innovation of medical devices, the implementation of special approval of innovative medical devices, to promote the popularization and application of new technologies in medical devices, and to promote the development of the medical device industry. Article 9 The applicant for registration of medical devices and the filer shall establish a quality management system related to the development and production of products and maintain effective operation. In accordance with the innovative medical device special approval procedures for approval of the domestic medical device application for registration, samples entrusted to other enterprises, should be entrusted with the corresponding production scope of the medical device manufacturer; does not belong to the innovative medical device special approval procedures for approval of the domestic medical device application for registration, samples shall not be entrusted to other enterprises to produce.
Article X of the medical device registration or filing affairs of the personnel should have the appropriate professional knowledge, familiar with the medical device registration or filing management of laws, regulations, rules and technical requirements.
Article XI The applicant or the filer to apply for registration or for the record, shall follow the basic requirements for the safety and effectiveness of medical devices, to ensure that the development process is standardized, and all the data are true, complete and traceable.
Article XII of the application for registration or for the record information should be used in Chinese. According to foreign language data translation, should also provide the original. Citation of unpublished literature, the owner of the information should be provided to license the use of documents. The applicant, the filer is responsible for the authenticity of the information.
Article XIII of the application for registration or for the record of imported medical devices, should be registered in the applicant or the filer or production address in the country (region) has been approved for marketing. The applicant or the filing of the applicant's place of registration or production address in the country (region) is not the product as a medical device management, the applicant or the filing of the applicant is required to provide relevant documents, including registration or production address in the country (region) to authorize the product on the market for sale of the documents.
Article XIV of foreign applicants or filers should be set up in China through its representative organizations or designated as an agent of enterprises in China, with foreign applicants or filers to carry out the relevant work. In addition to handling the registration or filing of medical devices, the agent shall also bear the following responsibilities: (1) liaison with the corresponding food and drug administration department, overseas applicant or filer; (2) truthfully and accurately convey the relevant regulations and technical requirements to the applicant or filer; (3) collect information on adverse events of post-marketing medical devices and feedback to the overseas registrant or filer, and report them to the corresponding food and drug administration department; (4) collect information on adverse events of postmarketing medical devices and feedback to the overseas registrant or filer, and at the same time report to the corresponding (d) Coordinate the recall of medical devices after listing, and report to the corresponding food and drug supervision and management departments; (e) Other joint and several responsibilities related to product quality and after-sales service. Article 15 The applicant or the filer shall prepare the product technical requirements of medical devices to be registered or filed. Class I medical device product technical requirements by the filer for the record submitted to the food and drug supervision and management department. Class II, Class III medical device product technical requirements by the food and drug supervision and management department in the approval of registration to be approved. The product technical requirements mainly include the performance indexes and test methods of the finished products of medical devices, of which the performance indexes refer to the functionality of the finished products that can be objectively determined, the safety indexes and other indexes related to quality control. Medical devices marketed in China shall comply with the technical requirements of the products approved or filed for registration.
Article XVI of the application for registration of Class II, Class III medical devices shall be registered test. Medical device testing organizations should be based on product technical requirements for registration testing of relevant products. Registration test samples should be produced in accordance with the relevant requirements of the quality management system of medical devices, registration test qualified before clinical trials or apply for registration. For the first class of medical devices for the record, the filer can submit a product self-test report.
Article XVII of the application for registration and inspection, the applicant shall provide the inspection agency for registration and inspection of the relevant technical information required, registration and inspection of samples and product technical requirements.
Order XVIII of the medical device testing organizations should have medical device testing qualifications, within the scope of its inspection and testing, and the applicant submitted to the pre-evaluation of product technical requirements. Pre-evaluation of opinions with the registration of test reports issued to the applicant. Not yet included in the scope of medical device testing organizations to undertake inspection of medical devices, the corresponding registration and approval department designated by the competent inspection agency for testing.
Article 19 of the same registration unit should be able to test the product should be able to represent the registration unit within the safety and efficacy of other products. Article 20 The clinical evaluation of medical devices refers to the applicant or the filer through the clinical literature, clinical experience data, clinical trials and other information on whether the product meets the requirements for use or the scope of application of the confirmation process.
Article 21 of the clinical evaluation data refers to the applicant or the filer of the clinical evaluation of the documents formed. Need to conduct clinical trials, the submission of clinical evaluation data should include clinical trial program and clinical trial report.
Article 22 of the first class of medical devices for the record, without clinical trials. Application for registration of Class II, Class III medical devices, clinical trials should be conducted. One of the following circumstances, can be exempted from clinical trials: (A) the mechanism of work is clear, the design is finalized, the production process is mature, has been listed in the same variety of medical devices for many years of clinical application and no record of serious adverse events, do not change the routine use of; (B) through the non-clinical evaluation can prove that the medical device is safe and effective; (C) through the same variety of medical devices or clinical trials or data obtained from the use of analysis and evaluation, can prove that the medical device is safe, effective; (C) through the same variety of medical devices or clinical use of data obtained from the clinical trial (C) through the clinical trials of the same variety of medical devices or clinical use of the data obtained by analyzing and evaluating, can prove that the medical device is safe and effective. Exempted from clinical trials of medical devices catalog by the State Food and Drug Administration to develop, adjust and publish. Not included in the directory of medical devices exempted from clinical trials, through the same variety of medical devices clinical trials or clinical use of data obtained by analyzing and evaluating, and can prove that the medical device is safe and effective, the applicant can be declared for registration to explain, and submit relevant information.
Article 23 to conduct clinical trials of medical devices, should be in accordance with the requirements of the quality management standard for clinical trials of medical devices, clinical trials in qualified institutions. Clinical trial samples should be produced in accordance with the relevant requirements of the medical device quality management system.
Article 24 of the third class of medical devices for clinical trials on human beings with high risk, shall be approved by the State Food and Drug Administration. Clinical trials need to be approved by the State Food and Drug Administration of the third class of medical devices catalog development, adjustment and publication.
Article 25 of the clinical trial approval refers to the State Food and Drug Administration, according to the applicant's application, the proposed clinical trial of medical devices, the degree of risk of clinical trials, clinical trial program, clinical benefit and risk of comparative analysis of the report for a comprehensive analysis, in order to decide whether to agree to carry out the clinical trial process.
Article 26 The need for approval of clinical trials of medical devices, the applicant shall, in accordance with the relevant requirements to the State Food and Drug Administration to submit reporting information.
Article 27 The State Food and Drug Administration accepts the application for approval of clinical trials of medical devices, shall accept the application within three working days from the date of the declaration of information forwarded to the technical review of medical devices. Technical review organization shall complete the technical review within 40 working days. The State Food and Drug Administration shall make a decision within 20 working days after the completion of the technical review. Permitted to carry out clinical trials, issued by the medical device clinical trial approval; not approved, shall state the reasons in writing.
Article 28 of the technical review process requires the applicant to correct the information, the technical review body shall inform the need to correct all the content. The applicant shall, within one year in accordance with the requirements of the notice of correction to provide additional information. The technical review body shall complete the technical review within 40 working days from the date of receipt of additional information. The applicant's time for additional information is not counted in the review time limit. The applicant fails to submit additional information after the deadline, the technical review by the technical review body to terminate the technical review, put forward the recommendation of disapproval, the State Food and Drug Administration approved the decision of disapproval.
Article 29 of the following circumstances, the State Food and Drug Administration shall revoke the approval of the clinical trial of medical devices have been obtained: (a) the clinical trial declaration of false information; (b) the latest research has confirmed that the original approval of the clinical trial of the ethical and scientific problems; (c) other circumstances should be revoked.
Article 30 of the clinical trials of medical devices should be approved within three years after the implementation; overdue implementation, the original approval of the document is annulled, the need for clinical trials should be reapplied. Article 31 The application for registration of medical devices, the applicant shall, in accordance with the relevant requirements of the food and drug supervision and management departments to submit declarations.
Article 32 The food and drug supervision and management department receives the application for the declaration of information for formal review, and according to the following circumstances were dealt with: (a) the application belongs to the department's terms of reference, the declaration of information is complete, in line with the requirements of the form of review to be accepted; (b) the declaration of information can be corrected on the spot, the error, the applicant should be allowed to make corrections; (c) the declaration of information is incomplete or does not meet the formal review requirements. (C) the declaration is incomplete or does not meet the formal review requirements, should be within five working days to inform the applicant needs to make corrections to all the contents of the late notification, since the date of receipt of the declaration of information is accepted; (D) the application does not belong to the department's terms of reference, the applicant should be informed of the inadmissibility of the instant. Food and Drug Administration acceptance or inadmissibility of applications for registration of medical devices, should be issued with the special seal of the department and the date of acceptance or inadmissibility of the notice.
Article 33 The acceptance of the application for registration of food and drug supervision and management department shall accept the application within three working days from the date of the declaration of information forwarded to the technical review body. The technical review body shall complete the technical review of the registration of Class II medical devices within 60 working days, within 90 working days to complete the technical review of Class III medical device registration. The need for external expert review, drug and device combination products need to be reviewed jointly with the drug review organization, the time required is not counted, the technical review body shall inform the applicant in writing of the time required.
Article 34 of the Food and Drug Administration in the organization of the technical review of the product can be access to the original research data, and the organization of the applicant for the development of the product, the production of quality management system verification. Domestic second and third class medical device registration quality management system verification, by the province, autonomous region, municipality directly under the Central Food and Drug Administration to carry out, in which the third class medical device registration quality management system verification, by the State Food and Drug Administration technical review body to inform the corresponding provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to carry out the verification, participate in the verification, if necessary. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration should be completed within 30 working days in accordance with the relevant requirements of the system verification. State Food and Drug Administration technical review body in the import of Class II, Class III medical devices to carry out technical review, that it is necessary to carry out quality management system verification, notify the State Food and Drug Administration quality management system inspection of technical institutions to carry out verification in accordance with the relevant requirements, if necessary, the technical review body to participate in the verification. Quality management system verification time is not calculated in the review time limit.
Article 35 of the technical review process requires the applicant to correct the information, the technical review body shall inform the need to correct all the contents. The applicant shall provide additional information in accordance with the requirements of the notice of correction within one year; the technical review body shall receive additional information from the date of completion of the technical review within 60 working days. The applicant's time for additional information is not counted in the review time limit. The applicant has objections to the content of the notice of additional information, you can submit written comments to the appropriate technical review body, explain the reasons and provide the appropriate technical support information. The applicant fails to submit additional information after the deadline, the technical review body to terminate the technical review, put forward a recommendation not to be registered, approved by the Food and Drug Administration to make a decision not to be registered.
Article 36 The acceptance of the application for registration of food and drug supervision and management department shall make a decision within 20 working days after the end of the technical review. Meet the safety and efficacy requirements, registration is granted, within 10 working days from the date of the approval decision to issue a certificate of registration of medical devices, after approval of the product technical requirements in the form of an attachment to the applicant. Not registered, shall state the reasons in writing, and at the same time inform the applicant the right to apply for review and apply for administrative reconsideration or administrative litigation according to law. Medical device registration certificate is valid for five years.
Article 37 The registration of medical devices, including licensing and registration matters. License matters including product name, model, specifications, structure and composition, scope of application, product technical requirements, imported medical devices, such as the production address; registration matters including the name and residence of the registrant, the agent's name and residence, the domestic production of medical devices, such as address.
Article 38 For the treatment of rare diseases and respond to public **** health emergencies urgently needed medical devices, food and drug supervision and management department can approve the registration of the medical device requires the applicant to further complete the relevant work after the product is listed, and will require the requirements set out in the medical device registration certificate.
Article 39 For the accepted application for registration, one of the following circumstances, the food and drug supervision and management department to make a decision not to register, and inform the applicant: (a) the applicant on the proposed market sale of medical devices for the safety and effectiveness of the study and its results can not prove that the product is safe and effective; (b) the registration of the information declared false; (c) the content of the registration declaration materials (C) the registration of the information is confusing, contradictory; (D) the content of the registration information and the declaration of the project is inconsistent with the obvious; (E) not registered in other cases.
Article 40 For the accepted application for registration, the applicant may, before the administrative licensing decision is made, apply to the food and drug supervision and management department accepting the application for withdrawal of the application for registration and the relevant information, and explain the reasons.
Article 41 For the accepted application for registration, there is evidence that the registration declaration information may be false, the food and drug supervision and management department may suspend the approval. After verification, according to the conclusion of the verification to continue to review or make a decision not to register.
Article 42 If the applicant disagrees with the decision of not registering made by the food and drug administration department, the applicant may, within 20 working days from the date of receipt of the notice of the decision of not registering, file an application for review with the food and drug administration department that made the approval decision. The content of the application for review is limited to the original application and the original declaration.
Article 43 The Food and Drug Administration shall make a decision on review within 30 working days from the date of acceptance of the application for review, and notify the applicant in writing. Maintenance of the original decision, the Food and Drug Administration no longer accept the applicant to apply for review again.
Article 44 The applicant for the food and drug supervision and management department of the decision not to register objections, and has applied for administrative reconsideration or administrative litigation, the food and drug supervision and management department does not accept the application for review.
Article 45 of the medical device registration certificate is lost, the registrant shall immediately in the original licensing authority designated by the media to publish a statement of loss. After one month from the date of publication of the statement of loss, apply to the original licensing authority for reissue, the original licensing authority within 20 working days to be reissued.
Article 46 The application for registration of medical devices directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party can be in accordance with the laws, regulations and other provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; the application for registration of medical devices for review, the food and drug supervision and management department that are Involving public **** interests of major licensing matters, shall be announced to the community, and hold a hearing.
Article 47 of the newly developed medical devices have not been included in the classification of the catalog, the applicant can apply directly for the third class of medical devices product registration, can also be based on the classification rules to determine the product category and to the State Food and Drug Administration to apply for confirmation of the category, to apply for product registration or for the product record. Direct application for registration of Class III medical devices, the State Food and Drug Administration in accordance with the risk level to determine the category. Domestic medical devices to determine the second class, the State Food and Drug Administration will be declared to the applicant's location in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for review and approval; domestic medical devices to determine the first class, the State Food and Drug Administration will be declared to the applicant's location in the municipal food and drug supervision and management departments for the record.
Article 48 The application for registration in the process of review and approval of patent disputes shall be dealt with in accordance with relevant laws and regulations. Article 49 The second and third class of registered medical devices, medical device registration certificate and its attachments set out in the content changes, the registrant shall apply to the original registration department to apply for registration changes, and in accordance with the relevant requirements for the submission of declarations. Product name, model, specifications, structure and composition, scope of application, product technical requirements, imported medical devices, such as changes in production address, the registrant shall apply to the original registration department for licensing changes. Registrant's name and residence, the agent's name and residence changes, the registrant shall apply to the original registration department for changes in registration matters; domestic medical device production address changes, the registrant shall apply for changes in registration matters after the corresponding change in production license.
Article 50 of the change in registration information meets the requirements of food and drug supervision and management shall be issued within 10 working days to change the registration of medical devices. Changes in registration information is incomplete or does not meet the formal review requirements, the food and drug supervision and management department shall inform the need to make corrections to all the contents.
Article 51 of the licensing matters for the change, the technical review body should focus on the changes in the review of the part of the change, the changes in the product is safe and effective to make an evaluation. Acceptance of applications for changes in licensing matters of food and drug supervision and management departments shall, in accordance with the provisions of Chapter V of these measures, the time limit for the organization of technical review.
Article 52 of the change in the registration of medical devices and the original medical device registration certificate used in conjunction with the validity of the registration certificate is the same. After obtaining the registration change document, the registrant shall modify the product technical requirements, instructions and labeling according to the content of the change.
Article 53 The acceptance of applications for changes in licensing matters and approval procedures, this chapter does not provide, the relevant provisions of Chapter V of these measures shall apply. Article 54 The expiration of the certificate of registration of medical devices need to renew the registration, the registrant should be in the expiration of the certificate of registration of medical devices before the expiration of six months, to the food and drug supervision and management department to apply for the renewal of registration, and in accordance with the relevant requirements for the submission of declarations. In addition to the provisions of Article 55 of these measures, the application for renewal of registration of food and drug supervision and management department shall be in the medical device registration certificate before the expiration of the validity of the decision to grant the continuation. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
Article 55 One of the following circumstances, shall not be renewed: (a) the registrant did not apply for renewal of registration within the prescribed period; (b) the mandatory standards for medical devices have been revised, the medical device can not meet the new requirements; (c) for the treatment of rare diseases and to deal with public **** health emergencies in urgent need of medical devices, the approval of the registration department in the approval of the listing of requirements, the registrant failed to meet the requirements within the prescribed period of time, the registrant can not reach the new requirements. Requirements, the registrant has not completed within the specified period of time the medical device registration certificate sets out the matters.
Article 56 The acceptance of applications for renewal of registration of medical devices and approval procedures, this chapter does not provide, the relevant provisions of Chapter V of these measures shall apply. Article 57 The first class of medical devices before production, should be for the product record.
Article 58 for the record of medical devices, the filing shall be in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article IX of the provisions of the filing information submitted. Filing information meets the requirements of the food and drug supervision and management department shall be filed on the spot; filing information is incomplete or does not meet the prescribed form, it shall be informed of all the contents of the need to make corrections at once, by the filer to make corrections for the record. For the record of medical devices, food and drug supervision and management departments shall, in accordance with the relevant requirements of the format of the record voucher, and will be filed in the information contained in the information table on its website to be published.
Article 59 has been filed for the record of medical devices, filing information on the content of the table and the filing of the technical requirements of the product changes, the filer shall submit a description of the changes and the relevant documents to the original filing department to change the filing information. Filing information in line with the formal requirements, the food and drug supervision and management department shall change the information contained in the change, the filing information on file.
Article 60 has been filed to adjust the management category of medical devices, the filer shall take the initiative to the food and drug supervision and management departments to cancel the original filing; management category adjustment to Class II or Class III medical devices, in accordance with the provisions of this approach to apply for registration. Article 61 The State Food and Drug Administration is responsible for the supervision and management of the national medical device registration and filing, the local food and drug supervision and management departments of medical device registration and filing work supervision and guidance.
Article 62 Provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration is responsible for the administrative region of the medical device registration and filing of supervision and management, supervision and inspection organizations, and will report the relevant information to the State Food and Drug Administration in a timely manner.
Article 63 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration in accordance with the principle of territorial management, the import of medical devices agent registration and filing of the relevant work of daily supervision and management.
Sixty-four municipal food and drug supervision and management departments shall regularly check the filing work, and timely to the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to report relevant information.
Article 65 The registered medical devices have laws and regulations should be canceled circumstances, or the registration certificate is not yet expired but the registrant takes the initiative to cancel, the food and drug supervision and management department shall cancel, and to the public.
Article 66 has been registered medical devices, its management category by the high category adjustment for the low category, in the validity of the medical device registration certificate continues to be valid. If you need to continue, the registrant should be in the medical device registration certificate expires six months before the expiration date, in accordance with the changed category to the food and drug supervision and management department to apply for renewal of registration or for the record. Medical device management category from the low category to adjust to the high category, the registrant should be in accordance with the provisions of Chapter V, in accordance with the changed category to the food and drug supervision and management departments to apply for registration. The State Food and Drug Administration in the management of the category adjustment notice shall provide for the completion of the adjustment of the time limit.
Article 67 Provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration in violation of the provisions of the implementation of medical device registration by the State Food and Drug Administration shall order a deadline for correction; failure to make corrections, the State Food and Drug Administration may directly announce the revocation of the medical device registration certificate.
Article 68 The food and drug supervision and management departments, relevant technical institutions and their staff, the applicant or the filer to submit the test data and technical secrets have the obligation of confidentiality. Article 69 Provide false information or take other deceptive means to obtain a medical device registration certificate, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article 64, paragraph 1 shall be punished. Provide false information for the record, in accordance with the "Regulations for the Supervision and Administration of Medical Devices" Article 65, paragraph 2 shall be punished.
Article 70 of the forged, altered, trading, leasing, lending medical device registration certificate, in accordance with the "Regulations for the Supervision and Management of Medical Devices" Article 64, paragraph 2 shall be punished.
Seventy-one violation of the provisions of these measures, not in accordance with the first class of medical devices change the record or the second class, the third class of medical equipment registration changes, in accordance with the "Supervision and Management of Medical Devices Regulations" shall be punished for failure to file the case.
Article 72 violation of the provisions of these measures, not in accordance with the provisions of the medical device registration license matters, in accordance with the "Supervision and Management of Medical Devices Regulations" on the failure to obtain a medical device registration certificate shall be punished.
Article 73 The applicant is not in accordance with the "Regulations for the Supervision and Administration of Medical Devices" and the provisions of this method to carry out clinical trials, by the food and drug supervision and management department at or above the county level shall order rectification, may impose a fine of 30,000 yuan; the circumstances are serious, shall immediately stop the clinical trial, has obtained approval for the clinical trial documents, be canceled. Article 74 The medical device registration or filing unit in principle to the product's technical principles, structural composition, performance indicators and scope of application for the division basis.
Article 75 of the medical device registration certificate in the "structure and composition" column contained in the combination of parts, in order to replace consumables, after-sales service, maintenance, etc., for the purpose of the original registered product, can be sold separately.
Article 76 of the medical device registration certificate format developed by the State Food and Drug Administration. Registration certificate number is arranged as follows: × 1 mechanical note × 2 ××××3 × 4 × × 5 ××××6. Which: × 1 for the registration and approval of the department of the location of the abbreviation: Domestic Class III medical devices, imports of Class II, Class III medical devices for the "country"; Domestic Class II medical devices for the registration and approval of the department of the location of the province, autonomous region, municipality directly under the Central Government abbreviation; × 2 for the registration and approval of the department of the location of the province, autonomous region, municipality directly under the Central Government abbreviation The abbreviation of province, autonomous region and municipality directly under the central government; ×2 for the registration form: "quasi" for domestic medical devices; "into" for imported medical devices; "permit" for Hong Kong, Macao, Taiwan medical devices, Medical devices in Hong Kong, Macao, Taiwan; ××××3 for the first registration year; × 4 for the product management category; × × 5 for the product classification code; ××××6 for the first registration number. Renewal of registration, ××××3 and ××××6 figures remain unchanged. Product management category adjustment, should be renumbered.
Article 77 of the first class of medical devices for the record voucher number is organized as follows: × 1 mechanical preparation ××××2 ××××3 number. Among them: × 1 for the record of the location of the department of the abbreviation: imported Class I medical devices for the "country"; domestic Class I medical devices for the record of the department's location in the province, autonomous region, municipality directly under the Central Government for the abbreviation of the location of the municipal administrative region (without the corresponding district of the municipal administrative region, only for the province, autonomous region, municipality directly under the Central Government for the abbreviation of the province, autonomous region, municipality directly under the Central Government for the abbreviation of the province, autonomous region, municipality directly under the Central Government for the abbreviation) ; ××××2 for the record year; ××××3 for the record running number.
Article 78 The registration and filing of in vitro diagnostic reagents managed as medical devices shall be governed by the Measures for the Administration of Registration of In Vitro Diagnostic Reagents.
Article 79 The emergency approval procedures for medical devices and special approval procedures for innovative medical devices shall be separately formulated by the State Food and Drug Administration.
Article 80 According to the needs of work, the State Food and Drug Administration may entrust the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration or technical institutions, relevant social organizations to undertake specific work related to the registration of medical devices.
Article 81 of the medical device product registration fees, fees and charges in accordance with the State Council, the competent departments of finance and price regulations.