Laws & Regulations/
Regulations for the Supervision and Administration of Medical Devices

Chapter I  General Provisions

Article 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medicaldevices, ensuring their safety and effectiveness and protecting human healthand life safety.

Article 2 All units or individuals engaged in theresearch and development, production, distribution, use, supervision andadministration of medical devices within the territory of the Peoples Republicof China shall comply with the Regulation.

Article 3  "Medical devices" as definedby these regulations refers to: any instrument, apparatus, appliance, material,or other article whether used alone or in combination, including the softwarenecessary for its proper application. It does not achieve its principal actionin or on the human body by means of pharmacology, immunology or metabolism, butwhich may be assisted in its function by such means; the use of which is toachieve the following intended objectives:

1. Diagnosis, prevention, monitoring, treatment or alleviationof disease;
2. Diagnosis, monitoring, treatment, alleviation of or compensation for aninjury or handicap conditions;
3. Investigation, replacement or modification for anatomy or a physiologicalprocess;
4. Control of conception.

Article 4  The drug regulatory authority under theState Council is responsible for supervision and administration of medicaldevices nationwide. The drug administration of the local government at countylevel and above is responsible for supervision and administration of medicaldevices in each administrative region. The drug regulatory authority under theState Council shall coordinate with other departments under the State Council,responsible for comprehensive economic administration, in the implementation ofpolicies for the medical device industry.

Article 5 The State shall classify medicaldevices and administer them based on this classification

Class I Medical Devices are those for which safety andeffectiveness can be ensured through routine administration;

Class II Medical Devices are those for which further control isrequired to ensure their safety and effectiveness

Class III Medical Devices are those which are implanted intothe human body, or used for life support or sustenance, or pose potential riskto the human body and thus must be strictly controlled in respect to safety andeffectiveness.

The classification catalogue for medical devices shall bestipulated, adjusted and promulgated by the drug regulatory authority under theState Council, in accordance with classification principles after consultingwith health authority under the State Council.

Article 6 Medical devices produced and used forthe purpose of providing concrete measuring values shall comply with therequirements of the metering law. The detailed product list shall be formulatedand promulgated by the drug regulatory authority under the State Council,jointly with the metering authority.

Chapter II  The Administrationof Medical Devices

Article 7 The State encourages the research anddevelopment of new medical devices. "New medical devices" refer tothe kind of brand new product varieties which have not been available in thedomestic market, or for which the safety, effectiveness and product mechanismhave not been recognized domestically.

The clinical trials of new medical devices of Class II andClass III can be conducted only after clinical trial approval by the relevantauthority in accordance with the rules of the drug regulatory authority underState Council.

New medical devices that have completed clinical trials andpassed experts evaluation and review organized by the drug regulatory authorityunder State Council, shall receive a new product certificate after beingapproved by the same organization.

Article 8 The State shall implement a productregistration system for the manufacturing of medical devices.

Class I medical devices shall be inspected, approved andgranted with a registration certificate by the drug regulatory authority of thegovernment of the municipalities consisting of districts.

Class II medical devices shall be inspected, approved andgranted with registration certificates by the drug regulatory authorities ofprovinces, autonomous regions and municipalities directly under the centralgovernment.

Class III medical devices shall be inspected, approved andgranted with registration certificates by the drug regulatory authoritydirectly under the State Council.

Clinical evaluation must be conducted for Class II and ClassIII medical devices before they are put into production.

Article 9 The drug regulatory authorities ofprovinces, autonomous regions and municipalities directly under the centralgovernment are responsible for the inspection and approval of the clinicaltrial or verification of class II medical devices in their own administrativeregions. The drug regulatory authority under the State Council is responsiblefor the inspection and approval of clinical trial or verification of class IIImedical devices.

Clinical trial or verification shall be conducted in themedical institutions designated by the drug regulatory authorities of thegovernment at provincial level and above. The medical institutions shallconduct the clinical trial or verification, in accordance with the relatedprovisions of the drug regulatory authority under the State Council.

The qualification of medical institutions engaged in the clinicaltrial or verification shall be certified by the drug regulatory authority,jointly with the health authority under the State Council.

Article 10 Medical institutions may developmedical devices to serve their own clinical needs, and use them within theirown institution under the guidance of licensed medical practitioners.

Class II medical devices developed by medical institutionsshall be inspected and approved by the drug regulatory authority of thegovernment at provincial level and above. Class III medical devices developedby medical institutions shall be inspected and approved by the drug regulatoryauthority under the State Council.

Article 11 When importing medical devices intoChina for the first time, the agent of the imported device, should submit theinstruction for use, quality standards, testing methods, other relevantinformation, product samples, and marketing authorization certificates issuedby the manufacturing countries (regions), for inspection and approval by thedrug regulatory authority under the State Council, and receive an importproduct registration certificate before applying for customs formalities.


Article 12 When applying for registration of medical devices, technicalstandards, testing report and other relevant information shall be submittedaccording to provisions of the drug regulatory authority under the StateCouncil.

The drug regulatory authority of the government of themunicipality consisting of districts shall decide within 30 working days if theproduct can be registered, counting from the date of acceptance of theapplication. For those not approved for registration, a written explanationshall be given to the applicant.

The drug regulatory authority of governments of provinces,autonomous regions and municipalities directly under central government shalldecide within 60 working days if the product can be registered, counting fromthe date of acceptance of the application. For those not approved forregistration, a written explanation shall be given to the applicant.

The drug regulatory authority under the State Council shalldecide within 90 working days if the product can be registered, counting fromthe date of acceptance of the application. For those not approved forregistration, a written explanation shall be given to the applicant.


Article 13  In case any situation reflected in the content of theregistration certificate is changed, the holder of the certificate shall applyfor an amendment of the certificate accordingly, or for re-registration within30 working days from the change.

Article 14 The term of validity for theregistration certificate of medical devices is four years. The holder of thecertificate shall apply for re-registration within six months before thecertificate expires.

When the manufacturing of a medical device is stoppedcontinuously for more than 2 years, its registration certificate isautomatically invalidated.

Article 15 Medical devices manufactured shall meetthe national standard, or professional standards when there are no relevantnational standards available.

National standards of medical devices shall be formulatedjointly by the standardization authority and the drug regulatory authorityunder the State Council. Professional standards of medical devices shall beformulated by the drug regulatory authority under the State Council.

Article 16 The instruction for use, label andpackage of medical devices shall comply with relevant standards or provisionsin China.

Article 17 The registration number of a medical deviceshall be marked on the product itself and the external package according to theprovisions of the drug regulatory authority under the State Council.

Article 18 The State implements a system ofre-evaluation and obsolescence for medical devices, the details of which shallbe formulated by drug regulatory authority under the State Council afterconsulting with other related authorities under the State Council.

Chapter III  Administration of Production,Distribution and Use
of Medical Devices

Article19 Enterprisesmanufacturing medical devices shall meet the following conditions:

1. Possess professional technicalpersonnel required for the manufacture of its medical devices;
2. Possess facility and environment required for the manufacture of its medicaldevices;
3. Possess equipment required for the manufacture of its medical devices;
4. Possess an establishment or personnel and equipment for quality testingrequired for the manufacture of its medical devices.

Article 20 Establishment of manufacturing of classI medical devices, requires that the enterprise file a record with the drugregulatory authority of provinces, autonomous regions or municipalitiesdirectly under the central government.

Establishing manufacturing of class II and/or class III medicaldevices, requires inspection and approval by the drug regulatory authorities ofthe provinces, autonomous regions and municipalities directly under the centralgovernment, who will then issue a Medical Device Manufacturing EnterpriseLicense. The industrial and commercial authority shall not issue a businesslicense to enterprises which have not received a Medical Device ManufacturingEnterprise License.

The term of validity of the Medical Device ManufacturingEnterprise License is 5 years. Upon expiration, re-inspection and licenserenewal shall be conducted. Implementation details shall be formulated by thedrug regulatory authority under the State Council.

Article 21 Medical device manufacturingenterprises shall not start manufacturing products before obtaining themanufacturing enterprise license.

Article 22 The State implements a mandatory safetycertification system for certain class III medical devices. A specific productlist shall be established by the drug regulatory authority under the StateCouncil, jointly with the quality and technology supervision authority.

Article 23 Enterprises distributing medicaldevices shall meet the following conditions:

1. Possess appropriate facility(s) and environment for the kindof medical devices to be distributed;

2. Possess appropriate quality inspection personnel for thekind of medical devices to be distributed;

3. Possess adequate ability for technical training, maintenanceand after-sales services for the kinds of medical devices to be distributed;

Article 24 Establishing of distribution of classII and/or class III medical devices, requires that the enterprise file a recordwith the drug regulatory authority of provinces, autonomous regions ormunicipalities directly under the central government.

Establishing an enterprise distributing class II and/or classIII medical devices, requires inspection and approval by the drug regulatoryauthorities of the provinces, autonomous regions and municipalities directlyunder the central government, who will then issue a Medical Device DistributingEnterprise License. The industrial and commercial authority shall not issue abusiness license to enterprises which have not received a Medical DeviceDistributing Enterprise License.

The term of validity of the Medical Device DistributionEnterprise License is 5 years. Upon expiration, re-inspection and licenserenewal shall be conducted. Implementation details shall be formulated by thedrug regulatory authority under the State Council.

Article 25 The drug regulatory authority ofgovernments of provinces, autonomous regions and municipalities directly undercentral government shall decide within 30 working days whether the licenses formanufacturing or distributing enterprises of medical devices can be issued,counting from the date of acceptance of the application. When a license is notissued, a written explanation shall be given to the applicant.

Article 26 Distribution enterprises and medicalinstitutions shall purchase qualified medical devices from enterprises having aMedical Device Manufacturing Enterprise License or Medical Device DistributionEnterprise License, and shall verify the certificates of qualified products.

Distribution enterprises shall not distribute medical deviceswithout registration certificates or certificates for qualified products, ormedical devices which are beyond their expiry dates, of compromisedeffectiveness, or obsolete.

Medical institutions shall not use medical devices withoutregistration, or certificate for qualified products, or medical devices whichare beyond their expiry dates, of compromised effectiveness, or obsolete.

Article 27 Medical institutions shall not re-usemedical devices labeled for single use, shall destroy them after use andestablish a record, according to relevant provisions of the country.

Article 28 The State shall establish a qualityincident reporting system and a warning system of medical devices.Implementation details shall be stipulated by the drug regulatory authorityunder the State Council, in conjunction with the health authority and familyplanning authority under the State Council.

Chapter IV  Supervision of Medical Devices

Article 29 The drug regulatory authorities ofgovernments at county level and above shall appoint medical device monitorswithin their organization, who are responsible for the supervision andinspection of medical device manufacturing enterprises, distributionenterprises and medical institutions within their own administrative regions.When necessary, monitors may take product samples and ask for relevantmaterials according to the provisions promulgated by the drug regulatoryauthority under the State Council. Institutions and individuals concerned shallnot decline cooperation or be deceitful in the monitoring process. The monitorsshall be responsible to keep collected samples and materials confidential.

Article 30 The State implements an accreditationsystem for the qualification of the testing institutions of medical devices.Only testing institutions accredited by the drug regulatory authority inconjunction with the quality and technical supervision authority under theState Council may conduct medical device test.

Medical device testing institutions and their staff membersshall keep strictly confidential all technical information provided byenterprises whose products are being tested, and shall not conduct or beinvolved in research and development, manufacture, distribution and technicalconsultation related to the devices tested.

Article31 Forproducts having caused or which may potentially cause quality incidents, thedrug regulatory authority of the governments at county level and above shallhave the right to check, seal up and detain them together with materialsrelated.

Article 32 The drug regulatory authority of thegovernments at provincial level and above shall revoke the registrationcertificates of medical devices of which safety and effectiveness can not beensured. Medical devices whose registration certificates have been revokedshall not be manufactured, distributed and used. Those already produced orimported shall be dealt with by the drug regulatory authority of government atcounty level and above.

Article 33 The drug regulatory authorities of thegovernment of the municipality consisting of districts and above, which performproduct registrations in violation of these regulations, shall be ordered bythe drug regulatory authority under the state council to correct the violationswithin a defined period. For those not corrected within the period, the productregistration certificates may be revoked and the events may be made public.

Article 34 Advertisements of medical devices shallbe reviewed and approved by the drug regulatory authority of governments atprovincial level and above, and shall not be published, broadcasted, circulatedor posted before the approval.

The contents of the advertisements shall be based on theinstruction for use approved by the drug regulatory authority under the StateCouncil or the drug regulatory authority of the governments of provinces,autonomous regions and municipalities directly under the Central Government.

Chapter V  Penalties

Article 35 In cases of manufacturing medicaldevices without product registration certificates, in violation of provisionsof these Regulations, the drug regulatory authority of governments at countylevel and above shall issue an order to stop the production, confiscate all ofthe illegally manufactured products and related illegal income. Additionally,in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 timesthe total sum of the illegal income shall be imposed; in case there are noillegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, afine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in seriouscases, the drug regulatory authorities of the governments at the provinces,autonomous regions and municipalities directly under the Central Governmentshall revoke the Medical Device Manufacturing Enterprise License; and in casecrimes are committed, criminal liability shall be investigated and handledaccording to the law.

Article 36 In cases of manufacturing class II andclass III medical devices without a Medical Device Manufacturing EnterpriseLicense, in violation of these regulations, the drug regulatory authority ofgovernments at county level and above shall issue an order to stop theproduction, confiscate all of the illegally manufactured products and theirillegal incomes. Additionally, in case the illegal incomes exceed RMB10thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomesshall be imposed; in case there are no illegal incomes or the illegal incomesdo not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30thousand yuan shall be imposed; and in case crimes are committed, criminalliability shall be investigated and handled according to the law.

Article 37 In cases of manufacturing medicaldevices not in conformity with national standards or professional standards formedical devices, in violation of provisions of these Regulations, the drugregulatory authority of governments at county level and above shall issue anwarning, followed with an order to stop the production, confiscate all of theillegally manufactured products and their illegal incomes. Additionally, incase the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times ofthe total sum of the illegal incomes shall be imposed; in case there are noillegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, afine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases,the product registration certificates shall be revoked by the authoritiesoriginally issued the certificates; and in case crimes are committed, criminalliability shall be investigated and handled according to the law.

Article 38  In cases of Distribution of class IIand class III medical devices without a Medical Device Distributing EnterpriseLicense, which violates provisions of these Regulations, the drug regulatoryauthority of governments at county level and above shall issue an order to stopthe production, confiscate all of the illegally manufactured products and theirillegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousandyuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall beimposed; in case there are no illegal incomes or the illegal incomes do notexceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousandyuan shall be imposed; and in case crimes are committed, criminal liabilityshall be investigated and handled according to the law.

Article 39 In cases of distributing medicaldevices without registration certificates or certificate for qualifiedproducts, or medical devices which are beyond their expiry dates, ofcompromised effectiveness, or obsolete, or purchasing medical devices fromenterprises without Medical Device Manufacturing Enterprise License or MedicalDevice Distributing Enterprise License, which violates provisions of theseRegulations, the drug regulatory authority of governments at county level andabove shall issue an order to stop the distribution, confiscate all of theillegally distributed products and their illegal incomes. Additionally, in casethe illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of thetotal sum of the illegal incomes shall be imposed; in case there are no illegalincomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB5 thousand to 20 thousand yuan shall be imposed; in serious cases, the MedicalDevice Distributing Enterprise License shall be revoked by the authoritieswhich originally issued the license; and in case crimes are committed, criminalliability shall be investigated and handled according to the law.

Article 40 In cases where false certificates,documents, materials, or product samples are submitted in registrationapplications, or obtaining medical device registration certificates areobtained using other deceitful means, which violate provisions of theseRegulations, the product registration certificates shall be revoked by theauthorities which originally issued the certificates, and within a period oftwo years, other product registration applications of the violating enterpriseshall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousandyuan shall be imposed; for enterprises already started manufacturing, all ofthe illegally manufactured products and their illegal incomes shall beconfiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of3 to 5 times of the total sum of the illegal incomes shall be imposed; in casethere are no illegal incomes or the illegal incomes do not exceed RMB10thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed;and in case crimes are committed, criminal liability shall be investigated andhandled according to the law.

Article 41 Violation of Article 34 of theseRegulations concerning provisions for advertisement of medical devices shall bedealt with by the industrial and commercial authority according to relevantlaws and regulations of the country.

Article 42 In cases of Medical institutions usingmedical devices without registration certificates or certificate for qualifiedproducts, or medical devices which are beyond their expiry dates, ofcompromised effectiveness, or obsolete, or purchasing medical devices fromenterprises without Medical Device Manufacturing Enterprise License or MedicalDevice Distributing Enterprise License, which violate provisions of theseRegulations, the drug regulatory authority of governments at county level andabove shall issue an order for correction, launch a warning, and confiscate allof the illegally used products and illegal incomes. Additionally, in case theillegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the totalsum of the illegal incomes shall be imposed; in case there are no illegalincomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge andother directly responsible personnel shall receive disciplinary punishment; andin case crimes are committed, criminal liability shall be investigated andhandled according to the law.

Article 43 In cases of medical institutionsre-using devices for single use, or not destroying devices which should bedestroyed, which violates provisions of these Regulations, the drug regulatoryauthority of governments at county level and above shall issue an order forcorrection and launch a warning, and may impose a fine of RMB 5 thousand to 30thousand yuan; in serious cases, the medical institutions may be applied with afine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and otherdirectly responsible personnel be applied with disciplinary punishment; and incase crimes are committed, criminal liabilities shall be investigated andhandled according to the law.

Article 44 In cases in which medical institutionsundertake clinical trials or clinical verifications of medical devices andprovide false reports, which violates provisions of these Regulations, the drugregulatory authority of governments at provincial level and above shall issuean order for correction and launch a warning, and may impose a fine of RM B 10thousand to 30 thousand yuanin serious cases, the qualification for clinical trial orclinical verification of medical devices shall be terminated, person(s) incharge and other directly responsible personnel shall receive disciplinarypunishment; an d in case crimes are committed, criminal liability shall beinvestigated and handled according to the law.

Article 45 For cases in which testing institutionsand their personnel are found to be conducting or involved in research and development,manufacturing, distribution and technical consultation of medical devices whichare related to the testing, or establishing false testing reports, whichviolates provisions of these Regulations, the drug regulatory authority ofgovernments at provincial level and above shall issue an order for correctionand launch a warning, and may impose a fine of RMB 10 thousand to 30 thousandyuan; in serious cases, the qualification for testing shall be terminated bythe drug regulatory authority under the State Council, person(s) in charge andother directly responsible personnel shall be receive disciplinary punishment;and in case crimes are committed, criminal liability shall be investigated andhandled according to law.

Article 46 In cases where personnel engaged insupervision and administration of medical devices abuse their power, pursuepersonal benefits by deceiving, or neglecting their duties, in violation ofprovisions of these Regulations, to the extent to which crimes are committed,criminal liabilities shall be investigated and handled according to the law.For those not committing crimes, disciplinary punishment shall be appliedaccording to the relevant regulations.

Chapter VI  Supplementary Provisions

Article 47 Provisions governing non-profitablecontraceptive devices shall be formulated separately by the drug regulatoryauthority in conjunction with other relevant authorities under the StateCouncil.

Article 48 These Regulations shall come into force from April 1, 2000.