Chapter 1 General Provisions
Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.
Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.
Article 4 The state shall classify medical devices and administer them based on this classification.
Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts.
Domestic Class II medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.
Domestic Class III medical device shall be inspected, approved and granted with registration certificate by State Food Drug Administration.
Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration.
Taiwan, Hongkong and Macao’s medical device registration shall refer to the regulation of imported medical device.
Medical devices certificate is valid for 4 years.
Article 5 Medical devices registration certificate shall be pressed by State Food Drug Administration and the content shall be filled in by inspection department of food drug administration.
Registration is arranged as the following:
x (x) 1(F) SFDA (x2) xxxx3x4xx5xxxx6, where:
x 1 Short form of the location of the registration and examination department:
For medical apparatus and instruments of Class 3 within our borders, medical apparatus and instruments abroad and those from Taiwan, Hongkong and Macao: it will be (C);
For medical apparatus and instruments of Class 2 within our borders: it will be the short form of the province, autonomous region or municipality directly under the Central Government where the departments for registration and examination are;
For medical apparatus and instruments of Class 1 within our borders: it will be the short form of the province, autonomous region or municipality directly under the Central Government where the departments for registration and examination are plus the short form of the administrative region at the municipality level in the community, i.e.x x 1 (It will be only the short form of the province, autonomous region or the municipality directly under the Central Government if there is no corresponding administrative region at the municipality level) ;
x 2 is the registration form (Approval, import and allowance)
“Approval” applies to medical apparatus and instruments within our borders;
“Import” applies to medical apparatus and instruments abroad;
“Allowance” applies to medical apparatus and instruments from Taiwan, Hongkong and Macao;
x x x x3 is the year for approval;
x 4 is the category of production administration;
x x 5 is the number of production variety;
x x x x 6 is the serial number of registration.
Medical device registration certificate is attached with medical device registration record, and shall be used along with medical device registration certificate.
Article 6 Manufacturers put forward medical device registration application, take relevant regal responsibility and keep medical device registration certificate after getting application approval.
Individuals who do medical device registration application should be authorized by manufacturer, possess professional knowledge, are familiar with medical device registration administration law, regulation, rules and technical requirement.
When doing imported medical devices registration, the overseas manufactures shall authorize an unit to be their agent in Chinese territory and the agent should take relevant legal responsibilities.
Meanwhile overseas manufactures shall authorize qualified body corporate or theirs own organ located in China to do after sales service.
Article 7 Medical devices which applying for registration shall have suitable product standard that can adopt state standard, industry standard or edit registration standard, but registration standard should not inferior to state standard or industry standard.
Registration standard shall be edited according to medical device standard administration regulation stipulated by state food drug supervision administration.
Article 8 Applying for Class II and Class III medical device registration, manufacture shall comply with relevant manufacturing condition or quality system requirement stipulated by state food drug supervision administration.
Chapter 2 Medical devices registration testing
Article 9 Class II and Class III medical devices shall be tested by medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine, then can be used in clinical trial or apply for registration.
The list of medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine (medical device testing organization for short in the following) shall be issued at another time.
Article 10 Medical device testing organization should do registration testing on applicant products according to available product standard including state standard, industry standard or registration product standards edited by manufacture within the specific testing range approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine.
For the medical device that have not been listed in testing range of all medical device testing organization should be tested by qualified testing united approbated by registration inspection department.
Imported medical device registration shall perform “Imported Medical Device Registration Testing Regulation”.
Article 11 Among one testing unit the tested product should be the typical product that can representing the safety and effectiveness of other products.
Article 12 For re-registration the same kind products which made of same material and manufactured by one manufacturer would not be tested for biological compatibility item during biological evaluation if manufacturing technics and intended use do not change.
When register the products which manufactured by one manufacturer, made of same material that have done biological evaluation and do not change their manufacturing technics, intended use and have no new potential biological risk would not be tested for biological compatibility during biological evaluation.
Article 13 Applying for Class II and Class III medical device registration will be exempted of doing registration testing if satisfy the following conditions:
1 Applying medical device and applied medical device is same in the basic principle, main function, structure, material and intended use.
2 The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification, meanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition.
3 Comparing with approved registration medical devices , the same kind of applying medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution.
4 The same kind of approved registration medical devices have not been found adverse events in the process of MDR.
5 The same kind of approved registration medical devices have not been found ineligible records in the process of product quality selective examination by food drug supervision administration within one year.
6 Overseas medical devices have got pre-market approval by overseas medical device supervision government.
Article 14 Applying for Class II and Class III medical device re-registration will be exempted of doing registration testing if satisfy the following conditions:
1 Applying re-registration medical device and applied medical device is same in the basic principle, main function, structure, material and intended use.
2 The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification, meanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition.
3 Comparing with approved registration medical devices , the same kind of applying re-registration medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution.
4 Applying for re-registration medical devices have not been found adverse events in the process of MDR within the expiration date of the former medical device certificate.
5 The former approved registration medical devices have not been found ineligible records in the process of product quality selective examination by food drug supervision administration within one year.
Article 15 Huge medical equipments which have got pre-market notification by overseas medical device supervision department, need special requirements on spot installation and have difficulty for testing can applying for postpone testing can be done supplement testing after getting medical device certificate.
For the products satisfied with above regulation that get registration approval when applying for postpone testing, the manufacture shall complete registration testing after importing the first medical device, until the testing is eligible the product can be put into use.
Chapter 3 Medical device clinical trial
Article 16 When applying for Class II and Class III medical devices registration, clinical trial material should be submitted.
The submission methods of clinical trial material shall comply to ‘Medical Device Registration on Clinical Trial Material Itemize Regulation’.(Refer to attachment 12)
Article 17 The clinical trial processed in China shall strictly comply to ‘Medical Device Clinical Trial Regulation’.
Article 18 The clinical trial material of medical devices processed in China shall include clinical trail agreement, clinical trial project and clinical trial report.
Food drug supervision administration could ask manufacture to provide clinical trial memorandum, acknowledgment letter and clinical trial original records.
Chapter 4 Medical device registration application and inspection
Article 19 When applying for medical devices registration, applicants shall accord with the medical device classification and apply to concerning food drug supervision administration according to item 4 of this methods.
Medical device user manual submitted by applicants shall accord with ‘Administration Regulation of Medical Device user manual, labeling and package '.
Applicants shall take the responsibility of the truth about the fully application material.
Article 20 Food drug supervision administration shall treat respectively depending on the following conditions:
1 If application articles legally do not belong to authorized scope of this department, should issue a rejection notice and advance applicants to apply for concerning administration unit.
2 If there is mistake in the application material that could be correct on-spot, the applicants shall be permitted to correct on spot.
3 If the application material is incomplete or not in accord with formal inspection requirement, please inform applicant on-spot or issue applicant with ‘Supplement Material Notice Letter’ within 5 workdays and inform applicant all the requested supplementary material at one time. Without informing within appointed period, the material receiving date should be regarded as the acceptance date.
4 It should be accepted if the application material is complete, accord with formal inspection request or applicants submit all requested supplement material according to the concerning requirements.
Whatever food drug supervision administration accept medical devices application or not, an acceptance notice or a rejection letter should be issued by department with special seal and date.
Article 21 Food drug supervision administration shall do substantiality inspection on application and make a paper decision on whether administer registration according to the stipulated term in item 22 of this method. On the condition that material accords with inspection regulation and administer registration, medical device registration certificates shall be issued within 10 workdays counted from date of the paper approval decision-making.
Article 22 Food Drug regulatory authority of the government of the municipalities consisting of districts shall make a division whether to administer registration within 30 workdays from the date of application.
Food Drug regulatory authorities of the provinces, autonomous regions and municipalities shall make a division whether to administer registration within 60 workdays form the date of application.
Food Drug regulatory authority directly under State Council shall make a make a division whether to administer registration within 90 workdays form the date of application.
In the process of inspection, if testing, technical review by specialists and audit are needed, the requested time is besides from the regulated period of this article. Food Drug Administration shall inform applicants with paper notice about the needed time.
Article 23 When apply for registration, the imported medical devices without marketing permission at overseas shall refer to registration technical inspection requirements of the domestic products in the same kind (the requested submission material shall refer to attachment 8 and attachment 9).
Article 24 In the inspection process of medical devices registration application material, SFDA shall issue paper supplementary notice to manufacture at one time if supplementary material is needed.
Manufacture shall submit all the requested supplementary material at one time according to requirement within 60 workdays. The additional time can not be counted to the SFDA’s substantial inspection time. Inspection shall be discontinued that manufactures do not supplement the requested material within regulated time and have no allowable reason.
Article 25 For the discontinued inspection, re-registration should not applied within 6 months from the discontinued date.
Article 26 If manufactures have suspicion for the supplementary material notice, a paper suggestion can be advanced to SFDA at limited time, explain excuse and offer technical supporting material that shall be inspected by SFDA, finally SFDA will give a decision.
Article 27 Basically the classification basis of medical devices registration unit is technological structure, performance and intended use.
Article 28 For medical devices registered as parts, applicants shall explain the recommended products, parts name, model and specifications to work with them.
A complete machine combined with all registered parts shall implement complete unit registration procedure.
When medical devices registering as a complete unit, its main deployment should be listed. A new re-registration should be requested if the main deployments change their performance and specifications.
If the combination parts which have been registered as a complete unit listed on column ‘performance, structure and components of the product’ of the ‘Medical Device Registration Record ’would be allowed to exempt from sole registration when be sold solely without changing its combination form and intended use.
Article 29 SFDA shall issue the condition, procedure, time limit, all requested material directory, samples of application letters of medical devices registration on administrative website and registration handling area.
Article 30 SFDA shall issue publicly of the inspection process and result during the inspection process of medical device application. Applicants and persons concerned would submit paper advice to state and excuse for the badly concerned matter.
Article 31 SFDA shall regularly issue the approved medical devices list on its government website for public reference.
Article 32 The food and drug supervision and administration department shall inform the applicant and the interested person that they have the right of applying for holding court when the application for medical apparatus and instruments registration directly deals with the great profit of the applicant and other persons, based on the laws, regulations and other stipulations of the food and drug supervision and administration. The food and drug supervision and administration department shall make public notice and hold court about the great permitted items dealing with the public interests during the examination of medical apparatus and instruments registration.
Chapter 5 Medical device re-registration
Article 33 Manufacturers shall re-register medical devices certificates within 6 months before expiration date if they would like to sell or use medical devices with overdue certificates.
Article 34 If any content in medical devices certificate listing below has changed, Manufactures shall apply for alteration and re-registration in 30 days from changing.
1 Specifications, models
2 Manufacturing address
3 Product standards
4 Performance, structure and components of product
5 Indications
Article 35 During medical device certificate validity period, if the administrative catalog changes, manufacturers shall apply for alteration and re-register according to the changed catalog in concerning regulatory authority of the government.
Article 36 When applying for re-registration, shall fill in medical device application form and submit application material requested by this method attachment 4,5 or 7 to SFDA.
If there is no regulation on re-registration acceptance and inspection procedure in this chapter, please refer to chapter 4 regulation.
Article 37 Re-registration is not allowed for any condition below:
1 Unfinished ( food ) drug supervision and management departments in the approval in accordance with the State Food and Drug Administration regulations the requirements
2 Belong to out of date catalogs when re-evaluated by SFDA.
3 Medical device certificates that were withdrawed by SFDA.
Chapter 6 Alterating and Supplementing of medical device certificates
Article 38 Any content listed in medical device has changed, manufactures shall apply for alteration registration on medical device registration certificates within 30 days from the altering date.
1 Manufacture substantiality does not change, name has been altered.
2 Manufacture registered address has been altered.
3 Literal alteration of manufacturing address.
4 Literal alteration of product name and trade name.
5 Literal alteration of specifications and models.
6 Literal alteration of name or code of product standard.
7 Agent changes.
8 After sales service changes.
Article 39 Applying for the alteration registration, should fill in medical device registration certificate alteration application form and submit concerning material and explanation to original registration inspection department according to this method attachment 10. Original registration inspection department shall inspect the format of material or inform applicants with all material requested to supplement on spot or within 5 workdays. Submit ‘acceptance letter ’ if all material according with requirements.
Article 40 Original registration inspection department shall issue a paper decision notice on whether agree to do alteration registration within 20 workdays from the date of accepting alteration application. If the alteration registration application is accord with regulation after being inspected, registration inspection department shall issue the altered medical device registration certificate and log out the original certificate. If the application is not accord with regulation after being inspected, the department shall make a unaccepted paper notice, explain the reason and inform the applicant that they have the legal right of applying for administrative re-inspection or administrative litigation.
The altered medical device registration certificates would use the original number, character ‘更’should be attached to the end of the number.
The altered medical device registration certificates shall have the same expiration date with the original certificates and shall be applied for re-registration after the expiration date .
Article 41 If medical device registration certificates are lost or damaged, manufactures shall submit material and explanation to original registration inspection department to apply for new transaction.
Chapter 7 Supervision Administration
Article 42 Food drug supervision administration department in charge of medical device registration inspection shall do inspection according to regulated procedure and make notice whether to admit registration. Who offend regulation shall be run relative obligation legally.
Article 43 If the food drug regulatory authority of the government above the municipalities consisting of districts offend the regulated methods and shall be corrective by the superior food drug administration department shall in time limit. If not be corrective in time limit, the superior would proclaim directly to withdraw medical device certificates. The withdraw certificates would not be sold or used, and the sold and used products shall be transacted by food drug regulatory authority above county.
Article 44 Food drug regulatory authority above province shall do technical re-evaluation for the marketed medical devices, and issue a notice of withdraw their medical device certificates and placard to society for those medical devices that can not have the anticipated usage and can not ensure safety and effectiveness .
Article 45 Any situation belongs to 《PRC Administration Admit Law》item 70, the original registration inspection department shall withdraw medical device certificates legally.
Chapter 8 Legal Responsibility
Article 46 Registration inspection department shall not accept or not admit registration and give warning, will not accept medical device registration application within 1 year if there is any situation belonging to the below: offend this regulated method, submit fake evidence, documentation and samples etc when applying for medical device registration or diddle medical device registration certificates by shocking ways of cheating or bribe. For the diddled certificates, they should be withdraw and would not applied for medical device registration application within 2 years, meanwhile will be punished by the regulation of ‘Medical Device Supervision Administration Regulation ’ article 40.
Article 47 For altering, buying and selling at a profit, renting or borrowing medical device certificates or other illegally forms to transfer certificates, food drug regulatory authority above the county government shall force them to corrective and fine under RMB30000.
Article 48 Food drug regulatory authority above province government shall punish according to the punishment regulation on without certificate of 《Medical Device Supervision Administration Regulation》for any of the following situation, that is disobeying article 33,34 or 35 of this method, not doing medical device re-registration but selling, the sold medical devices are not same to the limited content in the registration certificate or products user manual, labeling, package etc are not same to the limited content in the medical device registration certificates.
Article 49 Food drug regulatory authority above province government shall force to corrective or warn that violating article 38 of this method and do not do registration alteration. The government shall fine above RMB5000 under RMB10000 that exceeding the time limit.
Article 50 According to the Clause 15 of the method, the product which applied postponed testing after receiving certificate, but to be used before promised testing, the certificate of the product will be withdraw and publicized, and the issue will be put into the enterprise faith record.
If the registration testing is ineligible, State Food Drug Supervision Administration Department shall withdraw medical device certificates.
Chapter 9 Attachment
Article 51 Manufacturers mean who push product to market and will take legal responsibility for product.
Article 52 Registration products mean the registered medical device and medical devices that their user manual, labeling, package etc accord with content limited on medical device certificate.
Article 53 Medical devices which manufacture within the validity date shall be regarded as licensed products.
Article 54 In vitro agent which be registered according to medical device registration administration, its registration administration regulation shall be set separately.
Article 55 This method shall be explained by State Food Drug Administration.
Article 56 The regulations shall come into force from the proclamation date. The regulation of 《Medical Device Registration Administration Regulation》 issued at April 5th 2000 shall be abolished synchronously.