Decision No. 03/2008/QĐ-BYT stipulates the conditions for organizing human resources, material infrastructure, equipment, and the procedures for issuing operating licenses of tissue banks.

DECISION OF THE MINISTER OF HEALTH

REGULATING CONDITIONS FOR ORGANIZATIONAL HUMAN RESOURCES, INFRASTRUCTURE, EQUIPMENT

AND DOCUMENTATION, PROCEDURES FOR ISSUING OPERATING LICENSES FOR STEM CELL BANKS

THE MINISTER OF HEALTH

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Law on Organ Donation, Transplantation, and Human Body Parts Donation and Collection dated November 29, 2006;

At the proposal of the Director of the Department of Medical Examination and Treatment under the Ministry of Health,

DECISION:

Article 1. The Minister of Health hereby promulgates the regulations on conditions for organizational human resources, infrastructure, equipment, and documentation, procedures for issuing operating licenses for stem cell banks.

Article 2. These regulations apply to stem cell banks that operate independently.

Article 3. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 4. The Heads of the Ministry's Office, Inspectorate, Departments, and Bureaus, Directors of Health Services of provinces and centrally governed cities, directors of hospitals under the Ministry of Health, and heads of health services of relevant sectors are responsible for implementing this Decision./.

REGULATIONS

CONDITIONS REGARDING ORGANIZATIONAL HUMAN RESOURCES, INFRASTRUCTURE, EQUIPMENT

AND DOCUMENTATION, PROCEDURES FOR ISSUING OPERATING LICENSES FOR STEM CELL BANKS
(BIssued together with Decision No. 03/2008/QĐ-BYT

dated February 1, 2008 of the Minister of Health

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

1. A stem cell bank is a healthcare facility with legal personality, its own seal, and separate accounts.

2. Stem cell banks can be organized as single-type or multi-type banks, including the following types:

a) Stem cell banks under the Ministry of Health;

b) Stem cell banks affiliated with hospitals, medical universities directly under the Ministry of Health, or other ministries and agencies at the ministerial level;

c) Stem cell banks under provincial health services;

d) Stem cell banks under hospitals under provincial health services;

e) Private stem cell banks; stem cell banks affiliated with private hospitals, private medical universities.

3. Stem cell banks must meet the conditions regarding infrastructure, equipment, human resources, and be assessed and recognized as meeting the necessary conditions by the Ministry of Health before commencing operations.

II. SPECIFIC PROVISIONS

1. Organizational Human Resources

a) Human Resources:

Must have a sufficient number of technical staff specialized in surgery, biology, microbiology, hematology-immunology related to tissues, tissue preservation, and other related technologies such as cell culture, production of tissue-derived materials;

Must have a sufficient number of management, professional, and general workers to meet requirements, including those with college and vocational training levels (as specified in Appendix 1);

The professional manager of a stem cell bank shall comply with the provisions of Clause 4, Article 35 of the Law on Organ Donation, Transplantation, and Human Body Parts Donation and Collection.

b) Organization of Departments and Rooms, including:

General Planning Room;

Social Work Room: public education, counseling, registration for organ donation;

Technical Departments and Rooms.

2. Infrastructure and Facilities

a) Facilities include:

Tissue Reception Room;

Tissue Preservation and Storage Room;

File Storage Room, Information Coding Room;

Sterilization and Disinfection Room;

Laboratory and Animal Rearing Room;

Hematology-Immunology Transplant Laboratory;

Sterile Tissue Processing Laboratory;

Testing and Cell Culture Laboratory;

Workrooms for staff, ancillary facilities, etc.

b) Infrastructure includes:

Wastewater treatment system;

Clean water supply system, drainage system;

Fire prevention and control;

Medical waste and household waste disposal.

3. Medical Equipment

Ensuring basic techniques of stem cell banks such as collection, reception, preservation, storage, transportation, and supply of tissues (as specified in Appendix 2).

4. For stem cell banks affiliated with hospitals and medical universities, they may base their establishment on the regulations for independent stem cell banks and utilize hospital and university facilities and personnel (on a part-time basis) to meet the specific requirements for each type of stem cell bank.

III. DOCUMENTATION, PROCEDURES, AND AUTHORITY

FOR ISSUING OPERATING LICENSES FOR STEM CELL BANKS

1. Documentation for Applying for Operating Licenses for Stem Cell Banks

a) Application for Operating License;

b) Business Plan of the Stem Cell Bank, including organizational human resources, infrastructure, and medical equipment;

c) Decision on Establishment or Permission for Establishment of the Stem Cell Bank from the competent authority.

2. Procedures and Authority for Issuing Operating Licenses for Stem Cell Banks.

a) Step 1. The head of the institution submits a request to the Ministry of Health along with the application for an operating license for the stem cell bank;

b) Step 2. The Ministry of Health establishes an Evaluation Board to review the feasibility of the business plan of the stem cell bank.

Members of the Evaluation Board include experts in surgery, hematology, immunology, microbiology, embryology, pathology, quality control of medical products, and other related fields.

c) Step 3. Within 10 working days from the date of receipt of complete documentation, the Minister of Health issues a decision to establish the Evaluation Board. Within 15 days, the Board conducts the evaluation and reports the results to the Ministry of Health. Based on the evaluation results, the Minister of Health decides whether to recognize the bank as meeting the necessary conditions and issue an operating license; if the bank does not meet the conditions, the Ministry will notify the applicant within five days with the reasons./.