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Complete training courses related to specific cell therapy technologies announced by the central competent authority.Participated in human trials related to specific Schedule III cell therapy technologies.
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.
Medical institutions that implement cell therapy technology involving cell processing, culture, or storage should set up their own or entrust the cell preparation site to implement it.
The setting of the cell preparation site in the preceding paragraph shall comply with the relevant specifications for the good operation of human cell tissues announced by the central competent authority.
The institution to which the cell preparation site belongs in the first paragraph shall check the documents and materials that comply with the relevant provisions of the operation in the preceding paragraph, and apply to the central competent authority for approval; The same applies to the name, address, dedicated personnel, cell therapy technology items (indications) or implementing facilities of the institution or place, or the expansion of the premises.
When the central competent authority approves the approval in the preceding paragraph, it may verify the content and validity period of the approval; An organization may apply for an extension before the expiry of the time limit.
The central competent authority may conduct irregular inspections of the preparation site and may access relevant documents, materials and records; The preparation site and its personnel shall not circumvent, hinder or refuse; If the inspection results do not comply with the good operating standards for human cell tissue announced by the central competent authority, they shall be ordered to be corrected within a time limit, and if the circumstances are serious, the recognition of the cell preparation site may be stopped or revoked.
The matters to be handled by the central competent authority in the preceding three items shall be entrusted to the Food and Drug Administration of the Ministry of Health and Welfare.
The human cells and tissues used by medical institutions to implement cell therapy technology shall be limited to the provider of organ preservation banks. However, this does not apply under any of the following circumstances:
1. Obtained for the current treatment.
2. Obtained from the cell preparation site recognized by the central competent authority in accordance with paragraph 3 of the preceding article.
The qualifications, conditions, permits and other related matters for the establishment of organ preservation banks in the preceding paragraph shall be in accordance with the provisions of the Measures for the Management of Human Organ Preservation Banks.
The contents approved in paragraph 1 (2) shall include cell handling, culture and storage.
Medical institutions shall implement the plans approved by Articles 13 and 14; In addition to medical records, relevant records should be made and kept for at least 10 years, and the items and related materials of cell therapy announced by the central competent authority should be registered in the information system established by the central competent authority.
The contents of the records in the preceding paragraph shall include the date of treatment, place, content of treatment, adverse reactions and other matters designated by the central competent authority.
If an unexpected serious adverse reaction occurs when a patient receives cell therapy, the medical institution shall notify the central competent authority within seven days after learning the facts.
Medical institutions should explain the known effects, risks, possible adverse reactions, relief measures and other necessary matters of the technology to the patient or his legal representative, spouse, relative or related person, and obtain their consent and sign a consent form.
Medical institutions implementing cell therapy technology shall submit a report on the implementation results within three months of each year or within the period required by the central competent authority.
The contents of the report in the preceding paragraph shall include the following matters:
1. Number of treatment cases.
2. the therapeutic effect.
3. Adverse reactions or abnormal events.
4. Other matters designated by the central competent authority.
When necessary, the central competent authority may disclose the treatment statistics of medical institutions.
In any of the following circumstances, the central competent authority may stop or terminate all or part of the implementation of cell therapy technology by a medical institution, and notify the competent authority of the municipality directly under the Central Government or county (city):
1. Failure to implement in accordance with the approved plan
2. the number or severity of adverse events is abnormal
3. Failure to submit a report on the results of implementation in accordance with the provisions of the preceding article
4. The cell preparation site violates this Law or the relevant norms for the good operation of human cell tissues announced by the central competent authority, and obviously harms the rights and interests and safety of patients.
5. Other matters that obviously affect the rights and interests and safety of patients.
Where a medical institution applies for the suspension or termination of all or part of the implementation of cell therapy technology, it shall state the reasons and apply the procedures in the preceding paragraph.
For the technology in the preceding two paragraphs that has been stopped or terminated, the medical institution shall, within the time limit determined by the central competent authority, examine the follow-up treatment plan of cells, tissues and specimens and submit it for approval.
Section 2 Specific Aesthetic Medicine Surgeries
Medical institutions shall not perform the following specific aesthetic medicine surgeries on persons under the age of 18 except for the purpose of treatment:
1. Oculoplastic surgery.
2. Rhinoplasty.
3. Craniofacial plastic surgery.
4. Breast plastic surgery.
5. Hair transplantation.
6. Bone shaving.
7. Facelift.
8. Liposuction.
9. Genital plastic surgery other than circumcision.
Before a medical institution performs a specific aesthetic medicine operation, it shall, in accordance with the provisions of Article 63 of this Law, sign a consent form with the consent of the patient or his legal representative, spouse, relative or related person.
With the consent of the preceding paragraph, medical institutions shall give a period of full consideration, and shall not use coercion, inducement or other improper means.
Drugs used by medical institutions to perform specific aesthetic medicine surgeries shall have the certificate of drug import or manufacturing license approved and issued by the central competent authority.
Physicians who perform the following specific aesthetic medicine surgeries should be specialists in specialist subspecialties and screening methods, and should receive at least 24 hours of continuing education courses in aesthetic medicine surgery every three years:
1. Bone shaving.
2. Full face lift.
3. The amount of fat extraction in a single session is 1,500 ml or the total amount of fat and body fluids in a single time is 5,000 ml.
4. Abdominoplasty.
5. Rhinoplasty.
6. Breast plastic surgery for breast prosthesis implantation.
7. Whole body facelift.
Specialists who are sub-specialties and screening procedures may perform the following specific aesthetic medicine surgeries:
1. Facial bone cutting: plastic surgery, otolaryngology, oral color surgery, ophthalmology, neurosurgery and orthopedics.
2. bone cutting other parts other than the face: plastic surgery, orthopedics.
3. Full face lift: plastic surgery, otolaryngology, oral and temporal surgery, ophthalmology, dermatology, orthopedics and surgery.
4. Single fat extraction of 1,500 ml or total extraction of fat and body fluids of 5,000 ml: plastic surgery, dermatology, surgery and obstetrics and gynecology.
5. Abdominal plastic surgery: plastic surgery, obstetrics and gynecology, surgery and dermatology.
6. Rhinoplasty: otolaryngology, oral and temporal surgery, dermatology, surgery and plastic surgery.
7. Breast plastic surgery for breast implantation: plastic surgery and surgery.
8. Whole body facelift: plastic surgery.
Specialists in the departments of Specialty Physicians and Screening Measures, Obstetrics and Gynecology, Orthopedics, Otorhinolaryngology, Ophthalmology, Dermatology, Neurosurgery, Urology, Family Medicine, and Emergency Medicine shall meet the following conditions for performing aesthetic medicine surgeries in the preceding paragraph:
1. Participate in more than 10 cases of aesthetic medicine surgeries in the preceding paragraph, and obtain a certificate issued by a specialized medical association recognized by the central competent authority.
2. Have completed the relevant aesthetic medicine surgery training courses in the preceding paragraphs of the society recognized by the central competent authority for more than 32 hours, and obtained the certificate.
Specialists who belong to the subspecialties of specialists and the internal medicine, pediatrics, neurology, psychiatry, rehabilitation, anesthesiology, diagnostic radiology, radiation oncology, anatomical pathology, clinical pathology, nuclear medicine, and occupational medicine of the sub-specialties of specialists and the screening measures shall meet the following conditions for performing aesthetic medicine operations in the paragraphs of Article 26:
1. Complete a training course equivalent to three years of training for surgical specialists.
2. Participate in more than 10 cases of aesthetic medicine surgeries in each paragraph of Article 26 and obtain a certificate issued by a specialized medical association recognized by the central competent authority.
3. Complete the relevant aesthetic medicine surgery training course organized by the society recognized by the central competent authority in Article 26 for more than 32 hours, and obtain a certificate.
Article 25 When performing surgery in medical institutions, if it is a specific aesthetic medicine operation under general anesthesia or intravenous anesthesia without general anesthesia, a full-time or concurrently anesthesiologist shall be present throughout the operation, and shall personally perform anesthesia business at the time of operation.
If the intravenous anesthesia other than general anesthesia in the preceding paragraph is moderate or mildly sedative, it may be performed by a physician other than the surgeon who has received training in anesthesia, and is not subject to the restrictions prescribed by an anesthesiologist in the preceding paragraph.
Training institutions engaged in anesthesia-related training in the preceding paragraph shall apply to the central competent authority for accreditation; Trained physicians should complete all courses and obtain supporting documents.
Hospitals or clinics with less than 99 beds who perform specific aesthetic medicine procedures under Article 25 shall formulate an emergency evacuation referral plan and sign an agreement or contract with the evacuation hospital.
Physicians who have performed more than 30 operations under Article 25 before January 1, 108, and who have obtained certificates issued by specialized medical associations and full federations of physicians' associations recognized by the central competent authority, are not subject to the qualifications and conditions stipulated in Article 26.
Section 3 Other Specific Medical Technologies
For medical institutions that perform cell therapy technology and other specific medical technologies other than specific aesthetic medicine procedures, the items, medical institution conditions, operator qualifications, and other matters to be complied with are as stipulated in Appendix 1.
Medical institutions implementing other specific medical technologies in the preceding article shall comply with the indications recorded in the medical device license.
Chapter III Specific Examinations, Tests and Medical Instruments
Section 1 Specific Medical Instruments
The items for the implementation or installation of specific medical equipment by medical institutions, the conditions of medical institutions, the qualifications of operators, and other matters to be complied with are stipulated in Appendix 2.
The use or use of specific medical equipment in the preceding article by medical establishments, except as otherwise provided in these Measures, shall comply with the indications recorded in the medical equipment license.
Section 2 Laboratory development and testing for specific inspections and inspections
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