Medical Device Registration Management

Original Language Title: 医疗器械注册管理办法

Read the untranslated law here: https://www.global-regulation.com/law/china/161039/.html

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(August 9, 2004 the State food and Drug Administration announced come into force on the date of promulgation, 16th) Chapter I General provisions article to regulate the registration of medical device 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, the use of medical devices shall be registered in accordance with this approach, not medical device registration, shall sell, use.     Medical device registration in article, refers to in accordance with legal procedures, to be marketed, the use of the medical device safety and effectiveness evaluation system, to decide whether to agree to the sale and use of process.     Fourth national classification registry of medical devices.     Class I medical device in the territory by the municipal districts (food) drug regulatory authority reviewed, approved and issued registration certificate of medical devices.     Territory of class II medical devices by the provinces, autonomous regions and municipalities directly under the (food) review the drug regulatory agency, approved and issued registration certificate of medical devices.     Territory of class III medical devices by the State food and Drug Administration reviewed, approved and issued registration certificate of medical devices.     Outside the medical device review by the State food and drug administration, approved and issued registration certificate of medical devices.     Taiwan, Hong Kong and Macao medical device registration, except as provided in this way, a reference to foreign medical device processing.     Medical device registration certificate is valid for 4 years.     Article fifth medical device registration certificate by the State food and Drug Administration printed content by approving the registration of (food) fill out the drug regulatory agency. Registration number presentation is: x (x) (to eat) drug armed (x) xxxx XXXXXXX. : 1 2 3 4 5 6x for the registered seat of the approval authority referred to: 1 internally outside of class III medical devices, medical devices, as well as Taiwan, Hong Kong and Macao for medical devices "Guo"; class II medical device for registration and approval of Department is located in the territory of province, autonomous region, municipality directly under the acronym first category for registration and approval of medical devices sector is located in the territory of the province, autonomous Area, metropolitan districts where the abbreviation and city-level administrative areas referred to, XX (when there is no corresponding municipal administrative area divided into districts, only for the provinces, autonomous regions and municipalities directly under the short title); 1x for registration form (quasi, Jin, Xu): 2 "quasi" applies to the territory of the hospital             Therapy equipment "into" Word applies to foreign medical device; "" Word applies to Taiwan, Hong Kong and Macao medical devices; xxxx for the registration year; 3x for the product management category 4xx product code 5xxxx registered serial number.     6 medical device registration certificates accompanied by the registration form (see annex 1 of these measures), used in conjunction with the registration certificate of medical devices.     Sixth production enterprise registration certificate for medical device applications, bear the corresponding legal obligations and the registration certificate of medical devices after the application is approved.     Dealing with registration of medical devices, should be entrusted by the manufacturer, and have the appropriate expertise, familiar with the laws, rules and regulations of the medical device registration management and technical requirements.     Application of import medical device registration, designated agencies in China by foreign production enterprises shall act as agent, the agent shall bear the corresponding legal responsibility, and manufacturers outside of the territory of China shall entrust a qualified Corporation or authorize its institutions in China medical device service.     Article seventh registered medical devices, should be the applicable product standards, you can register the product using national standards, industry standards or to develop standards, but registered products may not be lower than the State standards or industrial standards.     Register product standard should be based on national standards for medical devices under the food and drug administration management request.     Article eighth application for class II and class III medical device registration, production enterprises shall comply with the provisions of the State food and drug administration conditions of production or a related quality system requirements.     Chapter II medical device registration in the Nineth test type II and class III medical devices by the food and drug administration in conjunction with the State General Administration of quality supervision, inspection and quarantine approved medical device inspection institutions to conduct testing, after testing in accordance with the applicable product standards, to be used in clinical trials or applied for registration.     The State food and drug administration in conjunction with the State General Administration of quality supervision, inspection and quarantine approved medical device inspection institutions (hereinafter referred to as medical device inspection institutions) be published in directory.     Article tenth medical device inspection institutions in the State food and drug administration and approved by the State administration of quality supervision, inspection and quarantine test within the production enterprise reporting based on the applicable product standards (including the application of national standards, industry standards or register product standard established by the manufacturer) to declare the product testing and issue a test report.     Has not been included in the medical device inspection institutions give a detection range of medical devices, specified by the competent departments in the corresponding register test Tester testing units.     Registration of import medical device testing implementation of the medical device testing regulation outside.     11th registered unit in the detection of the same product should be registered on behalf of the unit to the other product safety and efficacy of products.     12th the same manufacturers using the same raw material in the production of similar products, if the production and intended use remains the same, re-registration, the product of biological evaluation of biocompatibility tests can no longer.     The same production enterprises has been through the biological evaluation of raw materials used in the production of similar products, if the production process remains unchanged, intended use remains unchanged and no new potential biological risk, when applying for registration, the product of biological evaluation of biocompatibility tests can no longer. 13th article application second class, and third class medical devices registered, while meet following conditions of, can from registered detection: (a) by application registered of medical devices and this enterprise has allowed registered of medical devices of principle, main function, and structure, by with material, and material, expected uses belongs to same class; (ii) production enterprise has through medical devices production quality management specification check or has get medical devices quality system certification,     And production enterprise can provides by original enterprise production conditions review institutions recognized of detection report; (three) by application registered of medical devices and this enterprise has allowed registered and has through registered detection of similar products compared, not occurred involved security, and effectiveness change, or although involved security, and effectiveness change, but change part and by its caused products other related security, and effectiveness changes of part are has through has medical devices detection institutions detection;     (D) have been registered by the enterprise in accordance with the provisions of similar products for medical device adverse event monitoring, and have not seen serious adverse events; (e) has the similar products of the enterprise registration within 1 years free (food) the pharmaceutical supervisory and administrative department products quality supervision and inspection of substandard record; (vi) overseas medical devices have passed overseas medical device listing approval of the competent Department of the Government. 14th article application second class, and third class medical devices products again registered, while meet following conditions of, can from registered detection: (a) application again registered of medical devices and this enterprise has allowed registered of medical devices of principle, main function, and structure, by with material, and material, expected uses belongs to same class; (ii) production enterprise has through medical devices production quality management specification check or has get medical devices quality system certification,     And production enterprise can provides by original enterprise production conditions review institutions recognized of detection report; (three) application again registered of medical devices and has through registered detection of original registered products phase compared, not occurred involved security, and effectiveness change, or although involved security, and effectiveness change, but change part and by its caused products other related security, and effectiveness changes of part are has through has medical devices detection institutions detection;     (D) the application for re-registration of the medical device during the validity of the original registration certificate of medical devices in accordance with the provisions of the medical device adverse event monitoring, and have not seen adverse events; (v) the original registration of medical devices within 1 years free (food) the pharmaceutical supervisory and administrative department products quality supervision and inspection of substandard records.     Article 15th through overseas listing of medical device competent departments of the Government ratified, on the installation site has special requirements, difficulties in detecting large medical device may apply for suspension of testing, obtaining the registration certificate of medical devices to complement the product after testing. According to the provisions of the preceding paragraph apply for a deferred examination and be allowed to register the product, production companies must be the first medical device entry, and complete testing before going live.     After testing qualified before put into use.     16th chapter III medical device clinical trial application for type II and class III medical device registration shall submit clinical trial data.     Clinical trial data provide a means to implement the medical device register clinical trial information provision (see annex 12 to this method).     17th in China to conduct clinical trials of medical devices shall be subject to strict regulations on the implementation of the clinical trials of medical devices.     18th in China to conduct clinical trials of medical devices, clinical trials information should include clinical trial contract, clinical trial protocols, clinical trial reports.     (Food) the pharmaceutical supervisory and Administrative Department deems it necessary, may require the manufacturer to submit clinical trial information, informed consent, as well as clinical trial records. The fourth chapter of medical device registration application, examination and approval article 19th Medical device registration, the applicant shall, in accordance with the classification of medical devices, to the relevant provisions of this article fourth (food), apply to the pharmaceutical supervisory and administrative departments, and should fill out a medical device registration application form, these measures are in accordance with Annex 2, annex 3, Appendix 6, annex 8 and annex 9 will require the submission of application materials.     Application materials shall be in Chinese; the application materials according to translations of foreign language materials, should also provide the original text.     Statement of medical devices should be submitted by the applicant in accordance with the medical device brochures, labels and packaging regulations.     The applicant should be responsible for the authenticity of all of their application materials. 20th article (food) drug supervision management sector received application Hou, should according to following situation respectively made processing: (a) application matters law not belongs to this sector terms range of, should rates made not accepted of decided, and told applicants to about administrative organ application; (ii) application material exists can spot corrections of errors of, should allows application people spot corrections; (three) application material not complete or not meet form review requirements of, should spot or in 5 a days within to applicants     Notice of correction material, at once inform all applicants need to supplement content, fails to inform the, shall be accepted as of the date of receipt of the application materials; (d) the application materials are complete and conform to the form request for review or correction all application materials submitted as requested by the applicant, be admissible.     (Food) the pharmaceutical supervisory and administrative departments to accept or not to accept applications for registration of medical devices, shall issue a sealed by the sector-specific and indicate the date of the notification of acceptance or of the rejection notice. 21st (food) after the pharmaceutical supervisory and Administrative Department accepts registration of medical devices, shall, within the time limit stipulated in this article 22nd for substantive examination of applications and provide the written decision. Registered by the review meet the requirements of, since approval in writing within 10 working days from the date of the decision issued registration certificate of medical devices.     Review does not meet the requirements, to refuse to register a written decision, and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.     22nd District of the municipal (food) drug regulatory authority shall, within 30 working days from the date of acceptance of the application, make a decision on whether to grant registration.     Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall, within 60 working days from the date of acceptance of the application, make a decision on whether to grant registration.     The State food and drug administration shall, within 90 days from the date of acceptance of the application, make a decision on whether to grant registration. In the course of the review of applications for registration, needs testing, expert review and hearings, not counting the time required within the period specified in this section.     (Food) time required by the pharmaceutical supervisory and administrative departments shall inform the applicant in writing.     Article 23rd did not get permission from the overseas listing of medical devices medical devices outside, when applying for registration, reference to the territory of registration requirements for the technical review of the implementation of similar products (materials this approach to be submitted as Annexes 8, 9).     24th (food) in drug supervision and management in the technical review of medical device registration application materials, requires supplementary material production enterprises shall be one-time notice in written supplementary materials. Manufacturer shall, within 60 working days in accordance with the notice requirements material once complete, additional time not included in the (food) substantive examination within the period of the pharmaceutical supervisory and administrative departments.     Production companies did not, within the time limit set by supplementary material and there is no justified reason, terminate the review.     25th termination review of an application for registration, within 6 months after the termination of the review may not apply again.     26th production enterprises to supplement notice of objection, within the required time limit (food) drug supervision and management departments to submit written observations, justified and provide technical support materials (food) review the drug regulatory agency decisions.     27th medical apparatus product registered unit in principle to technological structure, properties and intended uses for the Division.     Registered 28th as part of the medical device, description should be used in conjunction with the part of the applicant's products, part names, types and specifications.     Already registered by combining parts into a whole, you must complete the whole registration procedures. Ready to register for medical devices, when applying for registration shall set out its main configuration.     If a main part specifications change machine should register again.     Ready to register for medical devices, the registration certificate of medical devices schedule "structure and components of the product performance" in the first column lists the combinations of parts without altering the composition and intended use case sold separately, may be exempted from a separate registration.     29th (food) administrative organ of the pharmaceutical supervisory and administrative departments shall Web site and registered office corresponding to the public medical device registration in required conditions, procedures, deadlines, need to submit all materials catalog and application model. 30th (food) the pharmaceutical supervisory and administrative departments to review the applications for registration of medical devices, should be public approval process and the results.     The applicant and interested parties to submit written views on matters directly related to the vital interests of State and to defend themselves.     31st state food and Drug Administration should be published regularly in their official site has list of medical device registration, is available for public inspection.     32nd 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 authority of other provides enjoys application hearing of right; in on medical devices registered application for review Shi, (food) drug supervision management sector think involved public interests of major license matters, should to social announcement, and held hearing. Reregister the 33rd of the fifth chapter of medical devices medical device registration certificate has expired, the need to continue to sell or use of medical devices, manufacturers shall within 6 months before the expiry date of the registration certificate of medical devices, applications due to re-register.     Of late, re-registration shall register the product testing.     Article 34th following changes in the registration certificate of medical devices, changes in production enterprise shall apply for re-registration of change within the 30th of: (a) the type, specification and (b) address, (iii) standard and (iv) performance structure and composition of the product; (e) the scope of products.     35th medical device registration certificate validity of the change management category of the product, manufacturers shall, within 6 months, according to the changed category to the (food) the pharmaceutical supervisory and administrative departments to apply for re-registration of change.     Article 36th applied for re-registration of medical devices should fill out application form for registration of medical devices, and in accordance with this Appendix 4 and in annex 5, or the corresponding requirements of annex 7 to the (food) drug supervision and management departments to submit application materials.     Re-registration of acceptance and approval procedure, not provided for in this chapter, these measures shall apply to the relevant provisions of the fourth chapter.     37th article has following case one of of medical devices, not again registered: (a) not completed (food) drug supervision management sector in approved listed Shi according to national food drug supervision authority about provides proposed of requirements of; (ii) by national food drug supervision authority again evaluation belongs to eliminated varieties of; (three) according to medical devices supervision Management Ordinance of provides revoked medical devices registered certificate of. Sixth chapter medical devices registered certificate of change and replacement 38th article medical devices registered certificate contains Ming content occurred following changes of, production enterprise should since occurred changes of day up 30th within application medical devices registered certificate change: (a) production enterprise entity not variable, Enterprise name change; (ii) production enterprise registered address change; (three) production address of text sex change; (four) products name, and commodity name of text sex change; (five) model, and specifications of text sex change; (six) products standard of name     Says the text or number change; (g) a change; (h) the service changes. 39th application for alteration of the registration certificate of medical devices, shall fill in the application form for change of registration certificate of medical devices, and in accordance with the requirements of annex 10 to this approach to the registration and approval of submitted materials and instructions.     Review of application materials form the original registration authority on the spot or within 5 working days once inform all applicants need to supplement content meet the requirements of the notice of acceptance will be issued. 40th after the original registration Department accepts change requests, and shall, within 20 working days whether or not to agree to change the written decision. Review of compliance to change, issue the certificate of registration of medical devices after the change, and the original registration certificate of medical devices to be cancelled.     Review does not meet the requirements, not to change the written decision, and explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.     Registration certificate of medical devices after the change with the original number, the number added in parentheses at the end of "more".     Medical device registration certificate for a further period after the change date and expiry date of the original registration certificate of medical devices the same expiry date shall apply for re-registration.     41st medical device registration certificate is lost or destroyed, production enterprises shall, in accordance with the requirements of annex 11 to this approach on the materials and instructions, apply to the registration and approval of Department for a replacement. The seventh chapter is responsible for the registration and approval of medical devices regulatory 42nd article (food) pharmaceutical supervisory and administrative departments shall, in accordance with the prescribed procedures for approval and make a decision on whether to grant registration.     For violations of registration approval, shall be investigated for responsibility. Article 43rd District, above the level of (food) in violation of these regulations provides for the drug regulatory agency of medical device registration, by its superior (food) pharmaceutical supervisory and administrative departments shall be ordered to rectify; fails, the superior (food) the pharmaceutical supervisory and administrative department can direct notice to revoke the registration certificate of medical devices.     Has been withdrawn registration certificate of medical devices medical devices shall not continue to sell and use after the sale of, use of, and above the county level (food) pharmaceutical supervisory and Administrative Department is responsible for the supervision of enterprises for processing. 44th or above the provincial level (food) the pharmaceutical supervisory and administrative departments on Postmarket medical device technical evaluation, and according to the technical evaluation results cannot be used to achieve the desired aim, cannot guarantee safe and effective medical devices, to repeal the decision of the registration certificate of medical devices, and announced to the public.     Has been withdrawn registration certificate of medical devices medical devices shall not continue to sell and use after the sale of, use of, and above the county level (food) pharmaceutical supervisory and Administrative Department is responsible for the supervision of enterprises for processing.     45th article of the People's Republic of China administrative licensing law of the 70th of the circumstances, the original registration departments shall cancellation of registration certificate of medical devices. Eighth chapter legal responsibility 46th article violation this approach provides, application medical devices registered Shi, take provides false proved, and file, and samples, false material, or to cheat, and bribery, not due means cheat medical devices registered certificate of, registered approval sector not accepted or not registered, and give warning, 1 years within not accepted its medical devices registered application; for its has cheat get of medical devices registered certificate, be revoked, 2 years within not accepted its medical devices registered application, and in accordance with     40th of the regulation on supervision and administration of medical devices of the rules will be punished.     47th alter, resell, lease or lend the registration certificate of medical devices, or in any other form of illegal transfer of registration certificate of medical devices, and above the county level (food) the pharmaceutical supervisory and administrative departments shall be ordered to correct, may be fined a maximum of 30,000 yuan.     48th article violation this approach 33rd article, and 34th article or 35th article of provides, not law handle medical devices again registered and sales of medical devices, or sales of medical devices and registered certificate qualified content different of, or products manual, and label, and packaging identifies, content and medical devices registered certificate qualified content different of, by County above (food) drug supervision management sector in accordance with medical devices supervision Management Ordinance on no medical devices registered certificate of punishment provides be punishment.     49th in violation of the provisions of this article 38th, not legally apply for alteration of the registration certificate of medical devices, and above the county level (food) pharmaceutical supervisory and administrative departments shall order within a time limit or to give warning fails, may impose a fine of less than 5000 Yuan and 10,000 yuan.     50th under this article 15th register to register the product again after testing medical devices, failing to finish testing products used in by the State food and Drug Administration revoke registration certificate of medical devices, it shall be announced and recorded into the enterprise credit file.     Product testing is not qualified by the State food and Drug Administration revoke registration certificate of medical devices.     Nineth chapter supplementary articles article 51st manufacturer refers to in its own name to market products, and ultimately body with legal responsibility for products.     52nd refers to medical device registration of registered products and their manuals, labels, packaging and other relevant content with the qualified medical device registration certificate consistent product.     53rd in the medical device registration certificate within the period of validity of the medical device as a certified product.     54th medical device registration management of in vitro diagnostic reagents, the registration management regulations shall be separately formulated by the State food and drug administration.     55th article of the approach by the State food and Drug Administration is responsible for the interpretation. 56th article of the way come into force on the date of promulgation.     On April 5, 2000, issued by the State Drug Administration registered medical devices regulations repealed simultaneously. Annex: 1. medical devices registered registration form type 2. territory first class medical devices registered application material requirements 3. territory second class, and third class medical devices registered application material requirements 4. territory first class medical devices again registered application material requirements 5. territory second class, and third class medical devices again registered application material requirements 6. outside medical devices registered application material requirements 7. outside medical devices again registered application material to Seeking 8. not get outside medical devices listed license of first class outside medical devices first registered application material requirements 9. not get outside medical devices listed license of second class, and third class outside medical devices first registered application material requirements 10. medical devices registered certificate change application material requirements 11. replacement medical devices registered certificate application material requirements 12. medical devices registered clinical test information points items provides annex 1: medical devices Registration form-(a) to medical device registration form: (b) import medical device registration form:

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