Provisions for Supervision and Administration of Medical Device Distribution

(Promulgated by Decree No. 54 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.)

Chapter I General Principles

Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices for the purpose of strengthening the supervision and administration of medical device distribution, regulating the distribution activities of medical devices, and ensuring the safety and effectiveness of medical devices.

Article 2 These Provisions shall apply to medical device distribution activities and their supervision and administration within the territory of the People's Republic of China.

Article 3 To engage in distribution activities of medical devices, an entity shall comply with requirements of laws, regulations, provisions, mandatory standards and the Good Supply Practice for medical device, and guarantee that information on medical device distribution process is authentic, accurate, integrated and traceable.

The registrant or filing entity of medical devices may sell by itself, or entrust medical device distributors to sell the medical devices registered or filed.

Article 4 Medical device distribution is subject to classified management in accordance with their degree of risks.

Class III medical device distribution shall be subject to licensing management; Class II medical device distribution shall be subject to filing management, while Class I medical device distribution could be carried out without licensing or filing.

Article 5 The National Medical Products Administration (NMPA) shall be in charge of supervision and administration of medical device distribution nationwide. 

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for supervision and administration of medical device distribution within their administrative areas.

The department in charge of drug supervision and administration at the level of a city divided into districts or at county level shall be responsible for supervision and administration of medical device distribution within their administrative areas.

Article 6 The drug regulatory departments shall set or designate professional technical institutions for inspection, testing, monitoring, and reevaluation, etc. of medical devices according to law, to assume relevant technical work and issue technical opinions in accordance with division of responsibilities, and provide technical support for supervision and administration of medical device distribution.

Article 7 NMPA shall strengthen the construction of information technology for supervision and administration of medical device distribution, and improve the level of online government services.

The drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be responsible for the construction and management of information technology for supervision and administration of medical device distribution within the administrative areas, and the coordination and promotion of information sharing on supervision and administration of medical device distribution as required by NMPA.

Article 8 The drug regulatory department shall promptly disclose information on licensing and filing, etc. of medical device distribution as well as the results of supervision, inspection and administrative penalties according to law, to facilitate public inquiry and accept social supervision.

Chapter II Distribution Licensing and Filing Management

Article 9 To engage in distribution activities of medical devices, the following conditions shall be met:

(1) having quality management agencies or quality management personnel compatible with the distribution scope and scale, and the quality management personnel shall have relevant professional degrees or titles;

(2) having the distribution premises compatible with the distribution scope and scale;

(3) having storage conditions compatible with the distribution scope and scale;

(4) having a quality management system compatible with the distributed medical devices;

(5) having quality management agencies or personnel providing professional guidance, technical training, and after-sales services compatible with the distributed medical devices.

Enterprises engaged in Class III medical device distribution shall also be equipped with computer information management system conforming to requirements of medical device distribution quality management system, to guarantee traceability of the products distributed. The enterprises engaging in Class I and Class II medical device distribution shall be encouraged to establish a computer information management system conforming to requirements of medical device distribution quality management system.

Article 10 An enterprise to be engaged in Class III medical device distribution shall file an application to the department in charge of drug supervision and administration at the level of a city divided into districts, and submit the following materials:

(1) copies of the identity and the academic degree or professional title of the legal representative (the person in charge of the enterprise) and the person in charge of quality;

(2) the organizational structure and department setting of the enterprise;

(3) the distribution scope and mode of medical devices;

(4) copies of the location maps, floor plans, and ownership certificate documents or lease agreements for the distribution premises and warehouses;

(5) the list of main facilities and equipment for distribution;

(6) the list of distribution quality management system, work procedures and other documents;

(7) the profile of the information management system;

(8) the authorization documents of the handling person.

The applicant for Medical Device Distribution License shall guarantee that the materials submitted are legal, authentic, accurate, complete, and traceable.

Article 11 Upon receipt of the application, the department in charge of drug supervision and administration at the level of a city divided into districts shall handle respectively according to the following circumstances:

(1) If the subject matter of application falls within the scope of this administrative authority, and the application dossiers are complete and conform to statutory form, then the application shall be accepted;

(2) If the application dossiers contain errors that can be corrected on site, the applicant shall be allowed to make corrections on site;

(3) If the application dossiers are not complete or do not conform to statutory form, the applicant shall be notified of all contents ought to be supplemented and corrected one-off on site or within 5 working days. If no notification is made within the prescribed time limit, the application shall be deemed to have been accepted upon receipt of the application dossiers;

(4) If the subject matter of the application does not fall within the scope of this administrative authority, a decision of not accepting the application shall be made immediately, and the applicant shall be notified of applying to relevant administrative authority.

For acceptance or non-acceptance of the application for Medical Device Distribution License, the department in charge of drug supervision and administration at the level of a city divided into districts shall issue an acceptance or non-acceptance notice fixed with special seal of the administrative authority and indicated with date.

Article 12 For matters of which a public hearing shall be held for implementation of administrative licensing as stipulated by laws, regulations, and provisions, or for other important administrative licensing matters involving public interests for which a public hearing needs to be held as deemed by the drug regulatory department, the drug regulatory department shall make an announcement to the public and hold a public hearing. If the application for Medical Device Distribution License involves vital interests between the applicant and others directly, then before making a decision on administrative licensing, the drug regulatory departments shall notify the applicant and the stakeholders that they are entitled to request for a public hearing.

Article 13 The department in charge of drug supervision and administration at the level of a city divided into districts shall, after accepting an application for distribution license, review the application dossiers, and carry out on-site inspection as required by the Good Supply Practice for medical devices when necessary, and make a decision within 20 working days upon the date of acceptance. If rectification is necessary, the rectification time shall not be included in the review time.

If specified conditions are met, a written decision on granting license shall be made, and the Medical Device Distribution License shall be issued within 10 working days; if specified conditions are not met, a written decision on not granting license shall be made, and the reasons shall be given.

Article 14 The Medical Device Distribution License shall be valid for 5 years, and indicated with the license number, enterprise name, unified social credit identifier, legal representative, person in charge of the enterprise, domicile, distribution premises, distribution mode, distribution scope, warehouse address, license issuing department, date of issuance, and valid term, etc.

The Medical Device Distribution License applies the uniform format made by NMPA, and shall be printed by the department in charge of drug supervision and administration at the level of a city divided into districts.

The electronic Medical Device Distribution License made by the drug regulatory departments shall be deemed equally authentic with the paper license.

Article 15 In case of changes in a Medical Device Distribution License, an change application in the Medical Device Distribution License shall be made to the former license issuing department, and relevant materials involving the change contents as stipulated in Article 10 of these Provisions shall be submitted. For changes in distribution premises, distribution mode, distribution scope and warehouse address, the drug regulatory department shall make a decision on whether granting the change or not within 20 working days upon the date of acceptance. When necessary, on-site inspection shall be carried out as required by the Good Supply Practice for medical devices.

If rectification is necessary, the rectification time shall not be included in the review time. If the change is not granted, the reasons shall be given in writing and notified to the applicant. For changes in other matters, the drug regulatory department shall grant changes on site.

The number and valid term of the Medical Device Distribution License after change shall remain the same.

Article 16 If the Medical Device Distribution License needs to be renewed upon expiration of the valid term, the medical device distributor shall apply for renewal within 30 to 90 working days before expiration of the valid term. If an application for renewal fails to be made within the prescribed time limit, such application shall no longer be accepted.

The former license issuing department shall review the application for renewal as stipulated in Article 13 of these Provisions, carry out on-site inspection if necessary, and make a decision on whether granting renewal or not before expiration of the valid term of the Medical Device Distribution License.

If specified conditions are met upon review, renewal shall be granted, and the number of the renewed Medical Device Distribution License shall remain the same. If specified conditions are not met, rectification within a prescribed time limit shall be ordered; if specified conditions are still not met upon rectification, renewal shall not be granted, and the reasons shall be given in writing. If no decision is made within prescribed time limit, it shall be deemed that renewal is granted.

If the license renewal is approved within the valid term of the former license, then the starting time of the renewal shall be the day following the expiry date of the former license; if the approval time is not within the valid term of the former license, then starting date of the renewal shall be the date approved for license renewal.

Article 17 If a distributor sets up warehouses across a city divided into districts, then the license issuing or filing department of the Medical Device Distribution License shall inform the department in charge of drug supervision and administration at the level of a city divided into districts where the warehouses are located.

Article 18 If a distributor sets up new independent distribution premises, it shall independently apply for Medical Device Distribution License or for filing.

Article 19 If the Medical Device Distribution License is lost, an application for re-issuance shall be made to the former license issuing department. The former license issuing department shall promptly re-issue the Medical Device Distribution License, and the number and valid term of the re-issued Medical Device Distribution License shall be consistent with those of the former license.

Article 20 In one of the following circumstances, the former license issuing department shall cancel the Medical Device Distribution License according to law, and make announcements:

(1) the cancellation is applied voluntarily;

(2) the License is not renewed upon expiration of the valid term;

(3) the eligibility as a market entity is terminated according to law;

(4) the Medical Device Distribution License is revoked or withdrawn according to law;

(5) other circumstances where administrative licensing shall be canceled as stipulated by laws and regulations.

Article 21 An enterprise to be engaged in Class II medical device distribution shall file the matter with the department in charge of drug supervision and administration at the level of a city divided into districts, and submit the related materials as prescribed in Article 10 of these Provisions (except Item (7)) to complete the distribution filing, and obtain the filing number.

The filing entity of medical device distribution shall guarantee that the materials submitted are legal, authentic, accurate, complete, and traceable.

Article 22 When necessary, within 3 months upon completion of filing, the department in charge of drug supervision and administration at the level of a city divided into districts shall carry out on-site inspection of the submitted materials and the implementation of the Good Supply Practice for medical devices.

If upon on-site inspection, it is discovered that the conditions are inconsistent with the submitted materials or do not conform to requirements of the Good Supply Practice for medical devices, rectification shall be ordered to be made within a prescribed time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be canceled, and an announcement shall be made public.

Article 23 If an entity applies for Class III Medical Device Distribution License and files for Class II medical device distribution concurrently, or has obtained Class III Medical Device Distribution License when filing for Class II medical device distribution, then it may be exempted from submitting corresponding materials.

Article 24 If Class II medical device distributors change its distribution premises, distribution mode, distribution scope, warehouse address, etc., it shall make filing of such changes promptly. When necessary, the department in charge of drug supervision and administration at the level of a city divided into districts shall carry out on-site inspection. If upon on-site inspection, the changes do not conform to requirements of the Good Supply Practice for medical devices, corrections shall be ordered to be made within a prescribed time limit; if the product safety and effectiveness cannot be guaranteed, the filing shall be canceled, and an announcement shall be made public.

Article 25 For those Class II medical devices of which product safety and effectiveness are not subject to influence of the circulation process, distribution filing may be exempted. The list of specific products shall be formulated, adjusted and announced by NMPA.

Article 26 An institution engaged in storage, allocation and supply of non-profit contraceptive medical devices shall conform to relevant regulations, without the need to apply for Medical Device Distribution License or filing.

Article 27 If the registrant or filing entity of medical devices sells its registered and filed medical devices at its domicile or manufacturing address, it does not need to apply for Medical Device Distribution License or filing, but shall meet the prescribed distribution conditions; if it stores and sells the medical devices in other places, it shall apply for Medical Device Distribution License or filing as stipulated.

Article 28 No entity or individual is allowed to falsify, alter, trade in, rent or lend out the Medical Device Distribution License.