Medical Device Registration Management

Original Language Title: 医疗器械注册管理办法

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Medical device registration management

    (July 30, 2014, the State food and drug administration released 4th come into force October 1, 2014) Chapter I General provisions

    First to standardize medical device registration and record management to ensure medical device is safe and effective, under the supervision and administration of medical devices Ordinance, these measures are formulated.

    Article in the People's Republic of China territory sales and use of medical devices, shall be in accordance with these regulations for registration or filing.

Third medical device registration is food and drug administration based on the applicant's application for medical devices, in accordance with legal procedures, on its planned medical device safety and effectiveness research and systematic evaluation of the results, to decide whether to agree to the application process.

    Record of medical devices medical device filing submitted filings to the food and drug administration, food and drug supervision and management departments to submit filings archive for future reference.

    Medical device registration and filing of the fourth article shall follow the open, fair and impartial principle. Fifth class I medical devices to implement records management.

Class II and class III medical device registration management.

Class I medical device in the territory for the record, the filing to the district, the municipal food and drug supervision and management departments to submit filings.

Domestic class II medical devices by the provinces, autonomous regions and municipalities directly under the food and Drug Administration reviewed, approved and issued registration certificate of medical devices.

Territory of class III medical devices by the State food and drug administration review, approved and issued registration certificate of medical devices.

Class I medical devices imported for the record, the record people submitted filings to the State food and drug administration.

Import category II and class III medical devices by the State food and Drug Administration reviewed, approved and issued registration certificate of medical devices.

    Hong Kong, Macao, Taiwan medical device registration, filing, and reference to import medical device processing.

    The sixth medical device registration in person, filing products to market in its own name on product liability. Article seventh released food and drug supervision and Administration Department shall timely medical device registration, record information.

    Applicants can check the approval progress and results, available to the general public of the outcome.

    The eighth State encourages research and innovation of medical devices, for innovative special examination and approval of medical devices, promoting the popularization and application of medical device technologies, promote the development of medical device industry.

    Chapter II basic requirements

Nineth and filing an application for registration of medical devices shall be established relating to product development, production and quality management system, and maintain effective operation.

    In accordance with the special procedure-approval of innovative medical devices medical devices registered in the territory, commissioned production of the samples, shall be entrusted with corresponding production range of medical device manufacturers; not in accordance with the special procedure-approval of innovative medical devices medical devices registered in the territory of samples shall not be entrusted to another production.

    Article tenth medical device registration or filing service personnel should have appropriate expertise, familiar with the management of medical device registration or filing laws, rules and regulations and the technical requirements.

    11th or filing applications for registration or filing of the applicant shall follow the basic requirement of medical device is safe and effective, ensure that the development process specifications, all data authenticity, integrity and traceability. 12th applied for registration or filing of information shall be in Chinese. Based on the translation of foreign language materials, should also provide the original text.

Reference document that is not published, shall provide proof of information used by the permission of the owner.

    Record is responsible for the authenticity of the data of the applicant.

13th applied for registration or filing of import medical devices should be in or filing registration or address of the applicant countries (regions) has been allowed to go on sale.

    Or filing registration or address of the applicant countries (regions) the products as medical devices are not managed, or filing required of the applicant to provide the relevant documents including registration or address the host country (region) to allow sales documents for the products listed.

14th overseas applicant or record shall be established in China through its representative bodies or designate an enterprise legal person acting as an agent in China, tie or filing relevant work of the applicant.

Agents in addition to medical device registration or filing matters, shall assume the following responsibilities:

(A) with appropriate food and drug regulatory agency, offshore or filing of the applicant's contact;

(Ii) to the applicant or for the record people truthfully and accurately communicate relevant regulations and technical requirements;

(C) collect Postmarket medical device adverse event information and feedback from register outside or record people, and to the corresponding report of the food and drug administration;

(D) coordinating the work after the listing of the product recall of medical devices, and the corresponding report of the food and drug administration;

    (E) other related to product quality and after-sales service of joint and several liability.

    Product technical requirements and registration chapter III inspection 15th or filing shall be drawn up of the applicant be registered or filing of medical device product specification. Product technical requirements for class I medical devices by the filing person filing submitted to the food and drug administration.

The second category, product technical requirements of class III medical devices approved by the food and Drug Administration approved registration.

Technology products mainly include medical equipment finished the performance criteria and test methods, performance refers to the functions that can be objectively determined product, safety indicators, as well as other indicators related to quality control.

    Registered in China-listed medical devices shall conform to the approved or registered product technical requirements. 16th section application for class II and class III medical device registration, registration test should be carried out.

Medical device inspection institutions related products should be based on technical requirements for products to be registered.

Registration test samples of production shall conform to related requirements for medical device quality management system, registration qualified to be tested in clinical trials or applied for registration.

    Handle the filing of class I medical devices, record people can submit a self test report.

    17th registered testing of an application, the applicant shall provide the inspection bodies with registration and inspection and the need for technology information, registered samples for inspection and technical requirements. 18th medical device inspection bodies shall have test qualification, testing in the context of the tester and pre-evaluation of technical requirements for the product submitted by the applicant.

Pre assessment issued along with the registration test report to the applicant.

    Have not been included in the medical device inspection inspection of medical devices, specified by the competent departments in the corresponding register members of the inspection bodies for examination.

    19th the same unit to inspect other products should be able to register on behalf of the unit product safety and effectiveness.

    Clinical evaluation of the fourth chapter

    20th medical device clinical evaluation refers the applicant or filing through clinical experience in clinical literature, data, and clinical trial information on whether products meet the requirements of or the scope confirmation process.

21st clinical evaluation refers to the applicant or filing for clinical evaluation form file.

    Need for clinical trials, clinical evaluation of information submitted should include the programme of clinical trials and clinical trial reports. Article 22nd record of class I medical devices, clinical trials are not required.

Application for class II and class III medical device registration, clinical trials shall be conducted.

Any of the following circumstances, clinical trials can avoid:

(A) the clear mechanism, design, sophisticated production technology, with variety of clinical applications of medical devices already on the market for many years and no serious adverse events recorded, does not change the General purpose;

(Ii) non-clinical assessment can demonstrate that the medical device is safe and effective;

(C) the same varieties of medical device clinical trials or clinical use of analysis and evaluation of data obtained, can demonstrate that the medical device is safe and effective. From the list of clinical trials of medical devices by the State food and Drug Administration be formulated, adjusted and published.

    Not included in the catalogue of products from clinical trials of medical devices, the same variety of medical device clinical trials or clinical use of analysis and evaluation of data obtained, can demonstrate that the medical device is safe and effective, can be addressed at the time of registration of the applicant, and submitted to the relevant supporting information. Article 23rd medical device clinical trial, should be in accordance with the requirements of clinical trials of medical devices quality management specifications, qualification within clinical trials.

    Clinical trial of production shall conform to medical devices quality management system requirements. 24th class III medical device clinical trials on humans are at higher risk, should be approved by the State food and drug administration.

    Need for clinical trial approval class III medical device listing by the State food and Drug Administration be formulated, adjusted and published.

    25th clinical trial approval refers to the State food and drug administration in accordance with the applicant's application for medical device for clinical trials to be carried out the degree of risk, clinical trial protocols, clinical benefit and risk analysis reports were analysed, to decide whether to agree to carry out clinical trial process.

    26th medical device clinical trials approval is required, the applicant shall, in accordance with the relevant request submission to the State food and Drug Administration declared data.

27th State food and Drug Administration medical device clinical trials after approval of the application shall, within 3 working days from the date of acceptance of the application will be declared information forwarded to the technical review of the medical devices Agency. Technical review technical review of agencies should be completed within 40 working days. The State food and drug administration shall take a decision within 20 working days after completion of the technical review. Admission to clinical trials and issued medical device clinical trial approval; approved, shall state the reasons in writing.
    28th require applicant to correct information in the technical review process, technical review of agencies should be told to correct everything at once. The applicant shall, within 1 year of notification's request to provide additional information in accordance with the corrections. Technical review of agencies should be within 40 working days of receipt of the additional information to complete the technical review.

Additional information not included in the review of the applicant within the time limit.

    The applicant fails to submit additional information, terminated by the Agency for the technical review technical review of proposed not to approve proposals, approval from the State food and Drug Administration not to approve the decision.

29th under any of the following circumstances, the State food and Drug Administration revoked approval of the clinical trials of medical devices should be documents:

(A) clinical trial information false;

(B) recent studies have confirmed the original clinical trial ethics and scientific problems;

    (C) other circumstances that should be withdrawn.

    30th medical apparatus should be implemented within 3 years after the approval of clinical trials; overdue implementation of the original file itself abolished, still need to be tested in clinical trials, should apply.

    The fifth chapter product registration

    31st medical device registration, the applicant shall, in accordance with the relevant request submitted to the food and Drug Administration to declare information.

Article 32nd after the food and Drug Administration receives the application form review of declarations, and are made according to the following process:

(A) the application belongs to the mandate of the Department, complete information, meet the review requirements, be admissible;

(B) reporting errors that can be corrected on the spot, shall permit the applicant to be corrected on the spot;

(C) the reporting forms are incomplete or do not meet the review requirements, shall inform the applicant within 5 working days once needs correction of all content, fails to inform the, starting from the day of receipt of the application materials shall be inadmissible;

(D) applications, not part of the mandate of the Department, shall immediately inform the applicant inadmissible.

    Food and Drug Administration to accept or not to accept applications for registration of medical devices shall seal and date the certificate with the sector-specific acceptance notice or inadmissible.

33rd accepts an application for registration of food and drug supervision and management departments should be within 3 working days from the date of acceptance of declarations referred to the technical review of authorities.

Agency shall, within 60 working days to complete the technical review class II medical device registration technical review, in class III medical device registration within 90 working days of the technical review process.

    Requires the external expert review, medical device combination products and drug review agency joint review, excluding the time required, technical review of agencies should be required to inform the applicant in writing.

34th technical review of food and drug supervision and management departments in the organization can access to original research materials, and organization of the applicant and the product development and production-related quality management system verification. The territory of class II and class III medical device quality management system registration verification, by the food and drug regulatory agency of provinces, autonomous regions and municipalities, including territory of class III medical device quality management system registration verification, technical review of the food and drug administration by the State agencies notify the appropriate provinces, autonomous regions and municipalities directly under the food and drug administration departments to carry out the verification and, if necessary, participate in the verification.

The provinces, autonomous regions and municipalities directly under the food and drug supervision and Administration Department shall, within 30 days in accordance with the relevant requirements complete system verification.

Technical review of the State food and drug administration institutions in the import category II and class III medical devices when conducting technical reviews, verification of the quality management system is considered necessary, informing the State food and Drug Administration Inspection Agency verification in accordance with requirements of quality management system and, if necessary, technical review of agencies involved in the verification.

    Verification time is not included in the review of the quality management system within the time limit. Applicant needs to supplement the information contained in the article 35th technical review process, technical review of agencies should be told to correct everything at once. The applicant shall, within 1 year of notification's request to provide additional information in accordance with the corrections and technical review body shall, within 60 working days from the date of receipt of the additional information to complete the technical review.

Additional information not included in the review of the applicant within the time limit.

Correction information to the applicant disagrees with the content, you can submit written observations to the appropriate agency for the technical review, state the reasons and provide technical support information.

    The applicant fails to submit additional information, terminated by the Agency for the technical review technical review of proposed recommendations that are not registered, after approval by the food and Drug Administration made the decision to refuse to register. Article 36th accepts an application for registration of the technical review of food and drug supervision and Administration Department shall take a decision within 20 working days of the end. To meet the requirements of safe, effective, and approval from the approval decision within 10 working days from the date of issue registration certificate of medical devices, approved product technical requirements to the applicant as an attachment.

To refuse to register, shall state the reasons in writing, and at the same time inform the applicant applied for a review and the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.

    Medical device registration certificate is valid for 5 years. 37th medical device registration include licensing and registration matters.

    Licensing matters, including product name, type, size, structure and composition, scope of application, product, technique request, imports of medical devices production address; the registration includes the name and domicile of the registered agent name and address, and production of medical devices, all within.

    Article 38th for the treatment of rare diseases and respond to public health emergencies urgently needed medical equipment, food and Drug Administration to approve the medical device registration requirements the applicant completing further work after the product launch, and requirements set out in the registration certificate of medical devices.

39th for accepting an application for registration, any of the following circumstances, the food and Drug Administration made the decision to refuse to register and inform the applicant of:

(A) the applicant for the proposed sale of medical devices safety and effectiveness research and its results could not prove that the product is safe and effective;

(B) false registration information;

(C) the registration documents of confusion, contradiction;

(D) the registration documents and the contents of declaration differs markedly from the project;

    (E) other circumstances that are not registered.

    40th for accepting an application for registration, applications can be processed before a decision of administrative license, to entertain the application of the food and drug administration permission to withdraw an application for registration and related information, and state the reasons. 41st for accepting an application for registration, there is evidence to show that the registration documents may be false, the food and Drug Administration may suspend approval.

    After verification, based on verification conclusions continue to review or make a decision to refuse to register. 42nd on food and drug supervision and Management Department of the applicant disagrees with the decision taken shall be rejected for registration and receipt shall be rejected for registration within 20 working days from the day of notification of the decision, made the decision on the approval of the food and Drug Administration Department of the application for review.

    Contents of the application for review is limited to original applications and declarations. Article 43rd food and drug supervision and Administration Department shall accept the application for review made within 30 working days from the date of decision, and notify the applicant in writing.

    Upheld the decision, the food and Drug Administration is no longer accepting applications for review the question once again.

    44th on food and drug supervision and management of the applicant disagrees with the Department's decision to refuse to register, and has been applying for administrative reconsideration or bring an administrative lawsuit, the food and Drug Administration does not accept its application for review. 45th medical device registration certificate is lost, the registrant should be immediately posted on the media specified in the original Licensing Office declared lost.

    Posted missing declaration after expiration of 1 month from the date of, the original issuing authority for replacement, the original issuing authority within 20 working days to be issued retrospectively.

    46th article medical devices registered application directly involved applicants and others Zhijian major interests relationship of, food drug supervision management sector should told applicants, and interest relationship people can in accordance with legal, and regulations and national food drug supervision management General of other provides enjoys application hearing of right; on medical devices registered application for review Shi, food drug supervision management sector think belongs to involved public interests of major license matters, should to social announcement, and held hearing.

47th on the new development has not been included in the category of medical devices, the applicant can apply for a class III medical device product registration, classification rules can be based on product categories and to apply to the State food and Drug Administration category is confirmed, to apply for registration or handling the products record. Directly to apply for registration of a class III medical device, the State food and Drug Administration determined according to the degree of risk categories.

    Medical equipment in the territory identified as second class, the State food and Drug Administration to transfer the information to the applicant where provinces, autonomous regions and municipalities directly under the food and drug administration review and approval territory identified as the first class of medical devices, the State food and Drug Administration declared data transfer where the applicant is located the municipal food and drug supervision and Administration Department for the record.

    48th registration occurs after the application review process and approval of patent disputes, should be dealt with in accordance with the provisions of relevant laws and regulations.

    The sixth chapter registration changes

49th registered to class II and class III medical device, medical device registration form and content changes set out in the annex, registered person shall apply to the registration change, and submitted declarations in accordance with the relevant requirements.

Product name, model number, specifications, structure and composition, scope, technology products, importing medical equipment production changes such as address, registered to the original registration shall apply for a license change. Name and domicile of the registered agent name and address changes, the Registrant shall apply to the registration of registration change; the territory of address changes for the production of medical devices, the Registrant shall be in the appropriate register change the license was changed.
    50th registration change of information to meet the requirements, the food and drug supervision and Administration Department shall, within 10 working days to file medical device registration changes.

    Registration change of information are incomplete or do not meet the review requirements, the food and drug supervision and management departments should be told to correct everything at once.

51st license change, institutions should be focused on the technical review section for review, an evaluation of the changes whether the product is safe and effective.

    Accept license request food and drug supervision and management departments should be in accordance with the approach of the fifth chapter organization technical review of a specified time frame. 52nd medical device registration change file merge with the original registration certificate of medical devices used, its validity period and the registration of the same.

    After obtaining the registered document, registered shall be modified according the changes to product specifications, instructions and labels.

    53rd license item change the admissibility of applications and approval procedures not specified in this chapter, these measures shall apply to the relevant provisions of the fifth chapter.

    Seventh chapter continues to register

54th medical device needs to extend the expiration of registration the registration of a registered person shall, on the expiry of the current registration certificate of medical devices 6 months ago, to register with the food and Drug Administration to seek an extension, and in accordance with the requirement to report information. Except as provided in this article 55th case, continue registration applications received food and Drug Administration should be made before the expiry of the current registration certificate of medical devices the decision to approve the extension.

    Fails to make a decision, considered to approve the extension.

55th under any of the following circumstances, refuse to continue registration:

(A) for applications for registration is not submitted within the deadline extended;

(B) medical device mandatory standards have been revised and cannot meet the new requirements of the medical devices;

    (C) for the treatment of rare diseases and respond to public health emergencies urgently needed medical equipment, approved the registration departments in approved requests, the registrant is not completed within the prescribed time of medical device registration form containing the matters.

    56th medical device continue accepting an application for registration, examination and approval procedures, not covered in this chapter, these measures shall apply to the relevant provisions of the fifth chapter.

    Eighth chapter product record

    Before the 57th class I medical device production, should go through the product record.

Article 58th of medical devices for the record, the record shall, in accordance with the medical device regulatory filings that the Nineth of provisions of legislation.

Record information to meet the requirements of, the food and drug supervision and Administration Department shall record on the spot; filings are incomplete or do not meet the requirements, should be told to correct everything at once, after correction for the record by record people.

    Record of medical devices, the food and drug supervision and management departments should make the record voucher in accordance with requirements, and record information posted on the website of the information in the table to be published. 59th record of medical equipment, posted record information in the table and record changes in technical requirements, the filing shall provide information and relevant documents, make changes to the original filing departments record information.

    Record information meets the requirements of form, the food and Drug Administration changes should be posted on the changes in the information, record data archive.

    60th filed adjustment of the management category of medical devices, the filing shall take the initiative to cancel the original filing to the food and Drug Administration Department; management category adjusting as class II or class III medical devices, registered in accordance with these measures.

    The Nineth supervision and management

    The 61st State food and Drug Administration is responsible for the national medical device registration and filing of regulatory work, local food and drug supervision and administration of medical device registration and filing work of supervision and guidance.

    62nd provincial, autonomous regional and municipal food and drug supervision and management is responsible for the administration of medical device registration and filing of regulatory work, organizations to carry out supervision and inspection, and relevant information submitted to the State food and drug administration in a timely manner.

    The 63rd of provinces, autonomous regions and municipalities directly under the food and drug supervision and management departments in accordance with the principle of territorial management, registration agent to import medical device conduct day-to-day supervision and management associated with the record.

    64th district, the municipal food and drug supervision and management departments should periodically check the records of, and to provinces, autonomous regions and municipalities directly under the food and drug supervision and management departments to submit relevant information.

    65th registered medical devices has laws and regulations should be written off, or registration certificate unexpired term but offered cancellation of a registered person, the food and drug supervision and management departments should be written off in accordance with law, and to the public. 66th registered medical device, the management category changed from high class to lower classes, within the period of validity of registration certificate of medical devices remains in force.

If continuation of the registered person shall, on the expiry of the current registration certificate of medical devices 6 months ago, in accordance with the changed category apply to the food and Drug Administration for an extension of registration or filing. Medical instruments management categories changed from low class to high class, the Registrant shall, in accordance with the provisions of chapter approaches the fifth, in accordance with the category of the change to the food and drug supervision and management departments registration.

    The State food and drug administration in the management category adjustment should be made to adjust the time limit stated in the notice.

    67th of provinces, autonomous regions and municipalities directly under the food and drug administration in violation of these regulations provides for registration of medical devices by the State food and drug administration of a rectification; fails, the State food and Drug Administration notice to revoke the registration certificate of medical devices directly.

    68th food and drug supervision and Management Department, technical institutions and their staff, the applicant or for the record submitted by the test data and technical secrets confidential.

    The tenth chapter legal liability

69th provides false information or take other dishonest means to achieve registration of medical devices, in accordance with the regulation on supervision and administration of medical devices shall be punished by the 64th article of.

    Providing false information when filing, in accordance with the regulation on supervision and administration of medical devices of the 65th of the second paragraph of article shall be penalized.

    70th article forge, alter, sell, lease or lend the registration certificate of medical devices, in accordance with the regulation on supervision and administration of medical devices shall be punished by the 64th article of.

    The 71st article violates these rules, not according to the first class I medical devices change the record or the second class, a class III medical device registration changes, under the supervision and administration of medical devices Ordinance relating to penalties that are not filed.

    72nd article violates these rules, fails to apply for alteration of the registration certificate for medical device licensing matters, in accordance with the medical devices regulatory Ordinance without obtaining the registration certificate of medical devices will be punished.

    73rd applicant are not in accordance with the regulation on supervision and administration of medical devices and clinical trials as provided herein, by the food and drug administration departments at or above the county level shall be ordered to correct, may be fined a maximum of 30,000 yuan; the circumstances are serious, shall immediately stop clinical trials, clinical trial approval has been made, to be cancelled.

    The 11th chapter by-laws

    74th medical device registration or filing unit in principle to principle, structure, performance indicators, and scope for the Division.

    75th medical device registration form in the "structure and components of the" bar of the combinations set out in parts, to replace consumables, service, repair, or otherwise for the purpose, for the original registration, can be sold separately.

76th medical instrument registration certificate format developed centrally by the State food and drug administration.

Presentation of the registration certificate number: X1 instrument x2xxxx3x4xx5xxxx6.

Of which:

X1 for registration and approval of Department seat of the abbreviations:

The territory of class III medical devices, class II and class III medical device imports as "State";

Second class for registration and approval of medical devices sector is located in provinces, autonomous regions and municipalities directly under the abbreviation;

X2 for registration form:

"Quasi" Word applies to the territory of medical devices;

"Into" Word applies to imported medical instruments;

"Given" Word as applied to Hong Kong, Macao, Taiwan area of medical instruments;

Xxxx3 for the first registration year;

X4 for the product management category;

Xx5 classification code for the product;

Xxxx6 to register the serial number for the first time. Continued registration of xxxx3 and xxxx6 numbers are not changed.

    Adjustment of the product management category, should be renumbered accordingly.

77th medical instrument registration certificate number of the first kind of presentation as follows:

X1 instrument xxxx2xxxx3.

Of which:

X1 seat of the filing Department abbreviations:

Class I medical devices imported for "country";

Class I medical devices for filing departments located in the territory of provinces, autonomous regions, municipalities directly under the abbreviation abbreviation plus seat area of the municipal boundaries (when there is no corresponding municipal administrative area divided into districts, only for the provinces, autonomous regions and municipalities directly under the abbreviation);

Xxxx2 for the filing year;

    Xxxx3 to record serial number.

    78th by management of in vitro diagnostic reagents for medical device registration and filing of application of the measures for the administration of registration of in vitro diagnostic reagents.

    79th medical emergency procedures and innovative medical devices special approval procedures formulated by the State food and Drug Administration separately.

    80th article in accordance with the needs, the State food and Drug Administration may appoint a province, autonomous region, or municipality directly under the food and drug administration or technical institutes, community organizations undertake specific work related to medical device registration.

    81st medical device product registration fees, fees in accordance with the relevant provisions of financial, pricing departments under the State Council. 82nd article of the rules take effect on October 1, 2014. Published on August 9, 2004 the management measures of medical device registration (former State food and drug administration, the 16th) repealed simultaneously.

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