State Drug Administration Order

Number 19

     The “Medical Device Distribution Enterprises Supervision & Administration Method” was examined and passed by the State Drug Administration on March 27th, 2000 and shall go into effect April 20th, 2000.

Director General: Zheng Xiaoyu

April 10th, 2000

Supervision & Administration on

Medical Device Distribution Enterprises

Chapter 1 General Provisions

Article 1 This method is hereby formulated with a view to strengthen the supervision and administration of Medical Device distribution enterprises, standardizing Medical Device manufacturing methods, and enforcing the regulations for the Supervision and Administration of Medical Device.

Article 2 All units or individuals engaging in the distribution of Medical Device within the People’s Republic of China, all levels of the Drug Administration Department shall comply with this method without exception.

Article 3 Enterprises engaged in the distribution of Class I Medical Device, shall file a record with the respective Drug Administration Department in the province, autonomous region, or municipality in which the enterprise is located.

Enterprises engaged in the distribution of Class II or Class III Medical Device shall apply for approval from the respective Drug Administration Department in the province, autonomous region, or municipality in which the enterprise is located and receive the “Medical Device Distribution Enterprises License”.

Chapter 2 Conditions for Enterprise Operation

Article 4 Medical Device distribution enterprises engaged in the distribution of Class II or Class III Medical Device must meet the following conditions:
     1. Enterprises shall possess corresponding technical personnel, be familiar with the national and local Medical Device supervision and administration statutes, regulations, and possess personnel with definite administrative ability.
     2. Enterprise must meet the following requirements:
     3. Possess corresponding distribution site and environment.
     4. Possess corresponding quality inspection personnel.
     5. Possess corresponding capability of training and after-sales service for product distribution
     6. Establish and strictly enforce necessary sanitation supervision systems in accordance with related national and local regulations.
     7. Enterprise shall collect and keep on record related medical device national standards, industry standards and medical device inspection and administration codes, regulations, and special rules.

Article 5 The Drug Administration of each respective province, autonomous region, and municipality shall combine the local governing region’s conditions and establish regulation on notarizing Medical Device distribution enterprise qualification. After reporting and filing to the State Drug Administration, the respective province, autonomous region, and municipality government may begin implementing said regulations. Regulation on notarizing Medical Device distribution enterprise qualification that distributes special types of medical devices, shall be formed, established, issued, and promulgated by the State Drug Administration.

Chapter 3 Record Filing, Inspection, and Approval

Article 6 Enterprises engaged in the distribution of Class I Medical Device shall fill out a uniform record form and forward to the respective province, autonomous region, or municipality where the enterprise is located. The record form shall be copied and forwarded by the Record Department to the Drug Administration of the respective local city.

Article 7 Upon the receipt of application for distributing Class II and Class III medical device, the respective province, autonomous region, or municipality should perform a thorough on-site inspection for the enterprise according to the “Enterprise qualification notarization regulation”, and issue a decision stating approved or not within 30 working days. Enterprise should be given a written notice of detail reasons if it is not passed. The next lower level of the Drug Administration can be entrusted to carry out the on-site inspection.

Chapter 4 Distribution Enterprises Administration

Article 8 Medical Device Distribution Enterprises shall not engage In the Following Activities:
     1. Falsify, change, transfer, or rent Medical Device Distribution Enterprises License.
     2. Distribute fake products.
     3. Distribute products manufactured by enterprises that are not filed or having a Medical Device Manufacturing Enterprise License.
     4. Distribute product that doesn’t have a Medical Device Registration Certificate of People’s Republic of China
     5. Distribute products that are expired, invalid, or declared obsolete by the government.
     6. Other activities prohibited by law, rules, or regulations.

Article 9 Medical Device Distribution Enterprises shall not sell their products to enterprises or medical organizations that do not possess either a “Medical Device Distribution Enterprise Record Form” or a “Medical Device Distribution Enterprise License”.

Article 10 Medical Device distribution enterprise that distributes products exceeding the scope of their distribution approval must re-apply and carry out the application process again.

Article 11 Medical Device distribution enterprises that engage in the distribution of Class III products shall create and effectively implement quality tracking reporting and complaint reporting systems.

Article 12 Medical Device distribution enterprise that temporarily or permanently cease business practice for one consecutive year or more, shall submit a written notification to the local Drug Administration at the county level or above, the enterprise is authorized to resume distribution once the notification is inspected and approved.

Article 13 Medical Device Distribution Enterprise that distributes Class II and Class III products should not stop the after-sale service for the sold products if it permanently or temporarily stop business.Article 14 In the event that there is a change to the Medical Device distribution enterprise’s legal representative, principle responsible individual, distribution location, or enterprise name, said enterprise shall carry out the modification application process to the Drug Administration of the respective province, autonomous region, or municipality directly under the central government where the enterprise is located.

Class III Medical Device distribution enterprises who change distribution location may only start distribution following approval by the Drug Administration of the respective province, autonomous region, or municipality directly under the central government where the enterprise is located.

Article 15 The Drug Administration of each province, autonomous regions, and municipality directly under the central government shall be responsible to organize the annual inspection of “Medical Device Distribution Enterprises Licenses”.

Medical Device Distribution Licenses shall be self-inspected by distribution enterprises every year. The self-inspection report shall be submitted to the Drug Administration of the respective province, autonomous regions, or municipality directly under the central government where the enterprise is located, and simultaneously apply for certificate inspection. The Drug Administration of the respective province, autonomous regions, or municipality directly under the central government may renewably carry out the on-site inspection if necessary. Enterprises failing annual inspection shall be forced to rectify within a set time limit. Enterprises that have already exchanged licenses do not need to be inspected in the same year.

Article 16 The “Medical Device Distribution Enterprise License” is valid for five years, six months prior to said permit’s expiration, the enterprise shall submit an application for certificate renewal and carry out the procedure for certificate renewal in accordance with the relevant regulation.

Chapter 5 Other Regulations

Article 17 The State Drug Administration shall uniformly print all “Medical Device Distribution Enterprises Record Forms” and all “Medical Device Distribution Enterprise Licenses”. The “Medical Device Distribution Enterprise Licenses” consists of one original a copy, and the copy has annual certificate inspection record.

The format for composing Record Forms numbers is as follows:

X₁ MDDERF No.XXXX₂XXXX₃

Note: MDDERF = Medical Device Distribution Enterprises Record Forms

The format for composing License numbers is as follows:

X₁ MDDEL No.XXXX₂XXXX₃

Note: MDDEL = Medical Device Distribution Enterprise Licenses

Note:

X ₁ is the abbreviation for the name of the file record or approving department of the Drug Administration of the respective province, autonomous regions, or municipality directly under the central government where the enterprises located.

XXXX₂ refers to the year.

XXXX ₃ refers to the sequence number.

Article 18 The scope of products approved for the “Medical Device Distribution Enterprise Certificate” shall be issued according to the classes, names, and class numbering system set forth in the “Medical Device Product Classification List”.

Chapter 6 Penalty Clauses

Article 19 The Drug Administration at the county level or above shall be enforced with issuing disciplinary warnings and correcting any violations of articles 11 or 14 of this method.

Article 20 The Drug Administration at the county level or above shall be enforced with issuing disciplinary warnings, correcting any violations of articles 12 or 13 of this method, and issuing related penalties of 10,000 RMB or less.

Article 21 The Drug Administration at the county level or above shall be responsible for enforcing correction of any violation of article 10 of this method and issuing related penalties of 30,000 RMB or less.

Article 22 The State Drug Administration shall enforce correction of any Drug Administration department of any province, autonomous region, or municipality directly under the central government department that issues a Medical Device Distribution Enterprise License that violates this method.

Chapter 7 Supplementary Articles

Article 23 The State Drug Administration shall be responsible for further clarification of any part of this method.

Article 24 This method shall come into force effect April 20, 2000.

Appendix:
    1. Medical Device Distribution Enterprise License (format)
    2. Medical Device Distribution Enterprises Record Form (format)

Appendix 1:

Medical Device Distribution Enterprise License (format)

X₁ MDDEL No.XXXX₂XXXX₃

Note: MDDEL = Medical Device Distribution Enterprise Licenses

_{------------------------------------------------:}

Your unit meets the Medical Device Distribution Enterprise Operation requirements according to The Medical Device Distribution Enterprises Supervision & Administration Method, and is hereby Officially licensed to distribute Medical Device products.

This License Specially Issued To:

Enterprise Registration Address:

Operating Address:

Product Range:

Principal Responsible Individual:

Legal Representative:

Dates of Validity:

XX Drug Administration

Year Month Day

Annual License Inspection Record 

Appendix 2:

Medical Device Distribution Enterprise Record Form (format) 

Note:
     1. This form is suitable for use with Medical Device distribution enterprises engaged in distribution of Class I products.
     2. This form requires both the signatures of the enterprise’s legal representative and the recording department’s seal followed by dates of validity.

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