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Cell Therapy
Taiwan Cell Therapy Regulation
Taiwan Cell Therapy Regulation
Chapter I General Provisions
These Measures are formulated in accordance with the provisions of Item 2 of Article 62 of the Medical Care Law (hereinafter referred to as this Law).
The terms used in these Measures are defined as follows:
1. Human cell tissues: refers to human cells, tissues, body fluids, or derived substances containing cells produced by non-genetic engineering experimental operations.
2. Specific medical technology: refers to cell therapy technology, specific cosmetic medicine surgery or other medical technology that can be implemented only if the qualifications of operating institutions and personnel should be restricted.
3. Cell therapy technology: refers to the technology of using human cells and tissues without binding drugs to rebuild the structure and function of the human body or treat diseases. However, the following technologies are excluded:
(1) Blood transfusion.
(2) Blood preparations.
(3) Bone marrow hematopoietic stem cell transplantation and peripheral blood hematopoietic stem cell transplantation.
(4) Artificial reproduction.
(5) Other items announced by the central competent authority.
4. Specific cosmetic medicine surgery: refers to the plastic surgery of the eyes, nose, ears, craniofacial, chest and abdomen, hair transplantation, bone peeling, facelift, autologous fat grafting, liposuction, genital plastic surgery other than circumcision, or other surgeries that simply improve the appearance of the body.
5. Specific inspections and inspections: refers to laboratory developed tests (LDTs) or other inspections and inspections that should limit the qualifications of operating institutions and personnel.
6. Laboratory development test: refers to the test established and used by a certified laboratory for the purpose of diagnosing, diagnosing or treating a specific patient or disease.
7. Specific laboratories: refers to laboratories established by non-medical institutions and licensed by the central competent authority to provide laboratory development and testing.
Medical institutions carrying out cell therapy technologies that are not human tests shall have the following documents and materials, apply for approval from the central competent authority, and register with the competent authority of the municipality directly under the Central Government or county (city) before they can do so:
1. Certificate of qualification of operating physician.
2. Proof of cell preparation site.
3. The implementation plan set forth in Article 13 or Article 14.
When the contents of the preceding paragraph are changed, they shall be implemented only after applying for approval and registration in accordance with the provisions of the preceding paragraph.
Medical institutions carrying out the specific aesthetic medicine surgical items specified in Article 25 shall have the following documents and materials checked and applied for approval and registration with the competent authority of the municipality directly under the Central Government or county (city) before they can do so:
1. Specialist certificate of surgeon.
2. Article 27 and Article 28: Physicians, with proof of their relevant training.
3. Emergency evacuation referral plan.
Medical institutions carrying out other specific medical technology projects specified in Section 3 of Chapter II shall present the following documents and materials and apply for approval and registration with the competent authority of the municipality directly under the Central Government or county (city) before they can do so:
1. The specialist certificate of the practicing physician and the certificate of professional training specified in Appendix 1.
2. Certificate of medical staff operating the equipment and professional training certificate specified in Appendix 1.
3. Medical equipment license.
4. Other supporting documents and materials stipulated by laws and regulations.
Medical institutions carrying out or using the specific medical equipment items specified in Section 1 of Chapter III shall present the following documents and materials and apply for approval and registration with the competent authority of the municipality directly under the Central Government or county (city) before applying for approval:
1. The practicing physician's specialist certificate and the professional training certificate specified in Schedule 2.
2. Certificate of medical staff for operation and professional training certificate specified in Appendix 2.
3. Medical equipment license.
4. Other supporting documents and materials stipulated by laws and regulations.
Medical institutions carrying out the specific inspections and tests specified in Section 2 of Chapter III shall have the following documents and materials, apply for approval from the central competent authority, and register with the competent authority of the municipality directly under the Central Government or county (city) before they can do so:
1. Medical staff certificates and professional training certificates for full-time quality supervisors, full-time technical personnel and personnel issuing test reports.
2. Professional training certificate of full-time testing development, analysis, calibration, biological information processing and other related personnel.
3. The implementation plan set forth in Article 36.
4. Article 37: Certificate of conformity of certified laboratories.
When the contents of the preceding paragraph are changed, they shall be implemented only after applying for approval and registration in accordance with the provisions of the preceding paragraph.
If a medical institution terminates or stops the operation or use of specific medical technology, examination, inspection or medical equipment after registration, implementation or use or changes in the physician or operator, it shall apply to the competent authority of the municipality directly under the Central Government or county (city) where it was originally registered to change the registration within 30 days of the occurrence of the fact; If it falls under Article 3 and the preceding Article, it shall first apply to the central competent authority for approval.
The technical, examination, inspection or medical equipment that has been terminated or stopped or used before the registration of the change in the preceding paragraph is completed shall not continue to be used or used; If the qualifications of the newly implemented physician or operator have not obtained the registration of the change in the preceding paragraph after 30 days from the date of occurrence of the fact, the technology, inspection, inspection or operation of the instrument shall not be performed.
Where a medical institution violates the provisions of the preceding two paragraphs, in addition to being punished in accordance with the provisions of paragraph 2 of the first paragraph of Article 103 and Article 107 of this Law, the competent authority of the municipality directly under the Central Government or county (city) shall notify the improvement within a time limit; If the improvement is made twice after the notice is limited to two times, and the improvement is not made within the time limit, the competent authority of the municipality directly under the Central Government or county (city) may cancel the registration.
Where a medical institution implements or uses specific medical technology, examination, examination or medical equipment and has indications that exceed the provisions of Chapters II and III, the competent authorities of municipalities directly under the Central Government and counties (cities) may revoke their registration, in addition to the penalties provided for in the second paragraph of the first paragraph of Article 103 and Article 107 of this Law. However, this does not apply under any of the following circumstances:
First, the situation is urgent.
2. Human tests approved by the central competent authority.
3. Others are subject to approval by the central competent authority.
Where a medical institution has had its registration revoked in accordance with these Measures, it shall not reapply for registration for the same item or use that specific medical technology, examination, laboratory or medical device within two months from the date of cancellation of registration.
Specific medical techniques, examinations, tests or medical equipment, equipment that can generate ionizing radiation or require the use of radioactive substances, shall comply with the relevant provisions of the Law on Protection against Ionizing Radiation.
Chapter 2: Specific Medical Technologies
Section 1 Cell Therapy Techniques
The physician who performs cell therapy technology should be a specialist in the field related to the disease and meet one of the following qualifications:
In accordance with Article 3, medical institutions shall apply for the implementation of the implementation plan for cell therapy technology required by Schedule III, and the content shall specify the following matters:
1. Name of the institution
2. Cell therapy projects
3. indications
4. Full-time operating physicians who comply with the provisions of the preceding article
5. Implementation methods
6. Evaluation and tracking of treatment effects
7. Fees and how they are collected
8. Published domestic and foreign literature reports
9. Model Consent Form
10. Cell preparation site
11. The composition, process and control methods of human cells and tissues
12. Relief measures for adverse reactions.
When necessary, the central competent authority may disclose the contents of all or part of the plans approved by medical institutions in the preceding paragraph.
In accordance with Article 3, medical institutions shall apply for the implementation of the implementation plan for cell therapy technology other than Schedule III, and the content shall specify the following matters:
1. Name of the institution.
2. Cell therapy projects.
Third, indications.
4. Full-time operating physicians who comply with the provisions of Article 12.
5. Implementation methods.
6. Evaluation and tracking of treatment effects.
7. Fees and how they are collected.
8. Reports on human test results that have been completed by themselves or participated in the implementation, and other domestic and foreign relevant literature reports.
9. Model Consent Form.
10. Cell preparation site.
11. The composition, process and control methods of human cells and tissues.
12. Relief measures for adverse reactions.
When necessary, the central competent authority may disclose the contents of all or part of the plans approved by medical institutions in the preceding paragraph.
The central competent authority may approve the implementation period of the application for the preceding article 2; Medical institutions may apply for an extension before the expiry of the time limit.
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