State Drug Administration Order

Number 18

      This Medical Device Manufacturing Supervision & Administration Method was created and passed by the State Drug Administration at the affairs meeting on March 27, 2000. It is henceforth passed and shall come into force beginning April 20, 2000.

Director General: Zheng Xiaoyu

April 10, 2000

Medical Device Manufacturing Enterprise

Supervision & Administration Method

Chapter 1 General Provisions

Article 1 These Regulations are hereby formulated with a view to strengthen the supervision and administration of Medical Device manufacturing enterprises, standardizing Medical Device manufacturing methods, and enforcing the Regulations for the Supervision and Administration of Medical Devices.

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

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

Enterprises engaged in the production of Class II or Class III Medical Device shall apply for approval with the respective Drug Administration Department of the province, autonomous region, or municipality directly under the central government in which the enterprise is located and obtain the Medical Device Manufacturing Enterprise License.

Chapter 2 Conditions for Enterprise Operation

Article 4 Medical Device production enterprises engaged in the production of Class II Medical Device must meet the following conditions:
    1. Enterprise’s principal responsible individual must possess proof of graduation from a technical secondary school or have completed education at or above the elementary level.
    2. Quality inspection organization’s principal responsible individual must possess proof of graduation from a technical secondary school or have completed education at or above the intermediate level.
    3. Enterprise’s work force shall possess a corresponding proportion of elementary level technical engineers.
    4. Enterprise shall possess the corresponding production quality inspection capability.
    5. Should possess corresponding storage location and environment for all manufactured products and their corresponding scale.
    6. Shall possess corresponding production facilities.
    7. Enterprise shall collect and keep on record related production and administrative laws, codes, regulations, and related technical standards.
    8. Enterprises engaged in the production of sterile Medical Device shall possess production facilities that are in accordance with regulations.

Article 5 Enterprises engaged in the production of Class III Medical Device must meet all conditions of Article 4 above and concurrently must meet the following conditions: Must possess at least one full-time specialist possessing an internal system quality examination certificate.

Must possess at least two corresponding full-time technical engineers who have successfully completed technical secondary school at the intermediate level or above.

Must possess at least two full-time inspection workers.

Article 6 The Drug Administration of each respective province, autonomous region, and municipality directly under the central government shall combine the local governing region’s conditions and establish Medical Device manufacturing enterprise qualification approval implementation regulations. After reporting and filing said qualification approval implementation regulations to the State Drug Administration the respective province, autonomous region, and municipality directly under the central government may begin implementation of said regulations.

The qualification approval implementation regulations for enterprises that produce types of medical instruments requiring special administration, shall be formed, established, issued, and promulgated by the State Drug Administration.

Chapter 3 Examination, Approval, and Recording

Article 7 Enterprises engaged in the production of Class I Medical Device shall fill out a uniform record form and forward to the respective province, autonomous region, or municipality directly under the central government where the enterprise is located. The record form shall be copied and forwarded by the Record Department to the Drug Administration department of the respective province, autonomous region, or municipality directly under the central government where the enterprise is located.

Article 8 The respective province, autonomous region, or municipality directly under the central government where the enterprise is located shall approve enterprises engaged in the production of Class III Medical Device and forward corresponding record files to the State Drug Administration.

Article 9 After the respective province, autonomous region, or municipality directly under the central government receives the application of the manufacturing enterprises that produce Class II and Class III Medical Device, it must perform a thorough on-site inspection of the enterprise according to the enterprise's qualification approval implementation regulations, and within 30 working days issue a decision stating whether or not the enterprise passed. Enterprises who are not issued a passing result shall be given a written notice detailing the reason for denial. The next lower level department of the Drug Administration can be entrusted to carry out the on-site inspection.

Chapter 4 Manufacturing Enterprise Administration

Article 10 Medical Device manufacturing enterprises that manufactures products exceeding the scope of their manufacturing approval must re-apply and carries out the application procedures again.

Article 11 Medical Device manufacturing enterprises shall not manufacture any products that do not have a corresponding People’s Republic of China Medical Device Registration Certificate.Article 12 Medical Device manufacturing enterprises that engage in the production of Class III products shall establish and effectively implement quality tracking reporting and complaint reporting systems.

Article 13 Medical Device manufacturing enterprises shall not sell their products to enterprises or medical organizations that do not possess either a Medical Instrument Distribution Enterprise Record Form or a Medical Instrument Distribution Enterprise License.

Article 14 The Medical Device Manufacturing Permit will be valid for five years, six months prior to said permit expiration, the enterprise shall submit an application for certificate exchange and carry out the procedure for certificate exchange in accordance with the relevant regulation.

Article 15 The Drug Administration of each province, autonomous region, and municipality directly under the central government shall be responsible for organizing the annual inspection of Medical Device Manufacturing Licenses.

Medical Device Manufacturing Licenses shall be self-inspected by manufacturing enterprises every 12 months. The self-inspection report shall be submitted to the Drug Administration of the respective province, autonomous region, or municipality directly under the central government where the enterprise is located, and said enterprise shall simultaneously apply for certificate inspection. The Drug Administration of the respective province, autonomous region, 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 re-exchange in the same year.

Article 16 Medical Device manufacturing enterprises producing Class II and Class III medical products that wish to restart production after one year or more of non-production shall submit a written report in advance to the respective Drug Administration of the province, autonomous region, or municipality directly under the central government where the enterprise is located. Upon approval of said report production can be restarted.

Article 17 In the event that there is a change to the Medical Device manufacturing enterprise’s legal representative, principle responsible individual, manufacturing location, or enterprise name, said enterprise shall carry out the modification application process with the respective Drug Administration of the province, autonomous region, or municipality directly under the central government where the enterprise is located.

Class II and Class II Medical Device manufacturing enterprises who modify or enlarge their manufacturing location may only begin production following approval by the Drug Administration of the respective province, autonomous region, or municipality directly under the central government where the enterprise is located.

Chapter 5 Other Regulations

Article 18 The State Drug Administration shall uniformly print all Medical Device Manufacturing Enterprises Record Forms and all Medical Device Manufacturing Enterprise Licenses. Said License shall consist of an original, copy, and an attached annual certificate inspection record.

The format for composing Record Forms numbers is as follows:

X₁ MDMR No.XXXX₂XXXX₃

Note: MDMR= Medical Device Manufacturing Record

The format for composing License numbers is as follows:

X₁ MDML No. XXXX₂XXXX₃

Note: MDML = Medical Device Manufacturing License

Note:

X₁ is the abbreviation for the name of the file record or approving department of the Drug Administration of the respective province, autonomous region, or municipality directly under the central government where the enterprises located.

XXXX₂ refers to the year.

XXXX ₃ refers to the sequence number.

Article 19 The scope of products approved for the Medical Device Manufacturing Enterprise Certificate should be issued according to the classes, names, and class numbering system set forth in the China Medical Device Product Class List.

Chapter 6 Penalty Clauses

Article 20 The Drug Administration at the county level or above shall be enforced with issuing disciplinary warnings and correcting any violations of articles 13 or 14 of this method.

Article 21 The Drug Administration at the county level or above shall be enforced with issuing disciplinary warnings, correcting any violations of articles 12 or 16 of this method, and issuing related penalties of 10,000 RMB or less.

Article 22 Any already licensed enterprise that presumes to manufacture products not meeting the regulation quality standards shall be fined according to the regulations found in the Medical Device Supervision and Administration Conditions.

Article 23 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 24 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 Manufacturing Enterprise License that violates this method.

Chapter 7 Supplementary Articles

Article 25 The State Drug Administration shall be responsible for further clarification of any part of this method.

Article 26 This method shall come into force beginning April 20, 2000.

Appendix:

    1. Medical Device Manufacturing Enterprise License (format)

    2.Medical Device Manufacturing Enterprises Record Form (format)

Appendix 1:

Medical Device Manufacturing Enterprise License (format)

Number: X₁ MDML No. XXXX₂XXXX₃

Note: MDML = Medical Device Manufacturing License

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

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

This License Is Specially Issued.

Enterprise Registering Address:

Manufacturing Address:

Product Range:

Principal Responsible Individual:

Legal Representative:

Date of Validity:

XX Drug Administration

Year Month Day

Annual License Inspection Record 

Appendix 2:

Medical Device Manufacturing Enterprise Record Form (format) 

Note:
      1. This form is suitable for use with Medical Device manufacturing enterprises engaged in production 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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