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Taiwan Cell Therapy Regulation

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Specific medical technology inspection, inspection of medical equipment, implementation or use of management measures⁠

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Chapter I General Provisions

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Article 1⁠

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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).

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Article 2⁠

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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.

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Article 3⁠

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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.

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Article 4⁠

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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.

This provision is annexed

Article 5⁠

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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.

This provision is annexed

Article 6⁠

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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.

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Article 7⁠

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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.

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Article 8⁠

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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.

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Article 9⁠

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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.

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Article 10⁠

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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.

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Article 11⁠

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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

This provision is annexed

Article 12⁠

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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:

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.

This provision is annexed

Article 13⁠

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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.

This provision is annexed

Article 14⁠

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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.

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Article 15⁠

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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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Article 16⁠

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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.

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Article 17⁠

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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.

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Article 18⁠

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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.

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Article 19⁠

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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.

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Article 20⁠

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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.

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Article 21⁠

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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

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Article 22⁠

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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.

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Article 23⁠

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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.

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Article 24⁠

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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.

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Article 25⁠

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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.

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Article 26⁠

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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.

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Article 27⁠

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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.

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Article 28⁠

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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.

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Article 29⁠

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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.

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Article 30⁠

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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.

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Article 31⁠

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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

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Article 32⁠

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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.

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Article 33⁠

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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

This provision is annexed

Article 34⁠

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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.

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Article 35⁠

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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

This provision is annexed

Article 36⁠

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Article 7, Paragraph 1, Laboratory Development Test Items shall be provided for as follows.

Medical institutions implementing the laboratory development and testing items in Appendix 4 of the preceding paragraph shall draw up an implementation plan specifying the following matters:

1. Name of medical institution.

2. Article 37: Certification laboratories and their implementation locations.

3. The person in charge of the certification laboratory and the quality supervisor.

4. Test items and report templates.

5. The medical institution's report signatory.

6. Fees and how they are collected.

7. Model Consent Form.

8. Evaluation method of test results for clinical application.

When necessary, the central competent authority may disclose all or part of the contents of the implementation plan approved in the preceding paragraph.

This provision is annexed

Article 37⁠

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Medical institutions carrying out laboratory development and testing shall be certified by the central competent authority or obtained the relevant accreditation qualifications announced by the central competent authority (hereinafter also referred to as "accredited laboratories").

The certification laboratories in the preceding paragraph may be set up by medical institutions or institutions, institutions, schools or legal persons.

The certification laboratory for laboratory development and testing in the first paragraph is a specific laboratory, and those who implement the testing items of Schedule 4 may carry out laboratory development and testing only from January 1, 15th year of the Republic of China, limited to those certified by the central competent authority; When the floor area of the laboratory's workplace is expanded, or the certification items are added or changed, the documents and materials shall be inspected and applied to the competent authority of the Taiwan authorities for change.

The central competent authority may conduct irregular inspections of the first certification laboratory and may access relevant documents, materials and records; Certification laboratories and their personnel shall not circumvent, hinder or refuse.

If the laboratory carrying out laboratory development and testing is located overseas, the laboratory shall comply with the provisions of the preceding three items and the country or region where the laboratory is located, and apply for a project license from the central competent authority.

For the first certification, the central competent authority may appoint the Food and Drug Administration of the Ministry of Health and Welfare or entrust other agencies, legal persons and organizations to do so; For the fourth check, the central competent authority may appoint the Food and Drug Administration of the Ministry of Health and Welfare.

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Article 38⁠

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Medical institutions carrying out laboratory development testing shall set up or entrust certified laboratories to do so; If it entrusts a certification laboratory, the entrusted laboratory shall place the following personnel:

1. Full-time quality supervisor: one person, with the qualification of medical examiner or specialist, and more than two years of experience in clinical laboratory quality management and related laboratory development and testing.

2. Full-time technical personnel: more than one person, with the qualification of medical examiner, and complete the training courses announced by the central competent authority, and obtain the certificate issued by the training unit.

3. Full-time testing development, analysis, calibration, biological information processing and other related personnel: one or more people, complete the training courses announced by the central competent authority and obtain the certificate issued by the training unit.

4. Personnel issuing test reports: one or more medical examiners or specialists who have undergone relevant training, and may be served by the personnel in paragraphs 1 and 2.

The qualifications and training of the personnel in paragraphs 2 and 3 of the preceding paragraph for overseas laboratories in item 5 of the preceding paragraph may be determined by the central competent authority and are not subject to the restrictions provided in the preceding paragraph.

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Article 39⁠

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Certified laboratories that carry out laboratory development and testing shall provide services according to the doctor's medical advice and the certified testing items, and make relevant records and issue test reports; Its records and reports shall be kept for at least seven years.

The test report in the preceding paragraph shall be signed or sealed by the person issuing the report; The content of the report shall include the information of the person being tested, the date, location, testing items, test results, testing restrictions, and other matters designated by the central competent authority.

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Article 40⁠

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Certified laboratories entrusted by medical institutions to carry out laboratory development testing shall provide original test records and result reports in accordance with the requirements of medical institutions, and shall not be refused.

The records and reports in the preceding paragraph shall not be provided or leaked to a third party other than the entrusted medical institution. However, unless otherwise provided by law, this shall not apply.

For the first report, the medical institution should be incorporated into the medical record for preservation.

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Article 41⁠

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In any of the following circumstances, the central competent authority may stop or terminate the implementation of laboratory development testing in the implementation plan of Article 36, 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. Commissioning a certification laboratory violates any of the circumstances in Items 1 to 5 of Article 37.

3. Violations of other laws and regulations, seriously affecting the rights and interests and safety of patients.

The period for stopping testing in the preceding paragraph shall be between six months and less than one year; If the test is terminated, the applicant shall apply for the test again after two years from the date of termination.

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Article 42⁠

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In any of the following circumstances, the central competent authority may stop or terminate the implementation or entrustment of one of the laboratory development and testing projects; If the circumstances are serious, all the laboratory development and testing items may be stopped or terminated:

1. Services not provided in accordance with the certified testing items.

2. Testing without medical advice or in accordance with medical advice.

3. Failure to make records, issue reports, or sign or seal in accordance with Article 39.

4. Making false records or issuing false reports.

5. Violating the provisions of Paragraph 3 of Article 37 by failing to obtain certification or modification permission from the central competent authority.

6. Violating the provisions of Item 4 of Article 37 by evading, obstructing, or refusing the central competent authority to conduct an inspection.

7. Failure to provide records or reports to medical institutions in accordance with the provisions of Paragraphs 1 or 2 of Article 40; or provide or disclose it to a third party other than the entrusted medical institution.

8. Violations of other laws and regulations seriously affect the rights and interests and safety of the inspected.

This provision is annexed

Article 43⁠

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Before the implementation of the amendments of the Republic of China on February 9, 100, medical institutions that have implemented the testing items of Schedule 4 and do not comply with the provisions of Articles 36 to 38 shall make corrections within three years from the date of implementation of the amendments and apply for approval and registration in accordance with Article 7.

Chapter IV Supplementary Provisions

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Article 44⁠

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These Measures shall take effect on the date of promulgation.

Chapter I General Provisions

Chapter 2: Specific Medical Technologies

Section 1 Cell Therapy Techniques

Section 2 Specific Aesthetic Medicine Surgeries

Section 3 Other Specific Medical Technologies

Chapter III Specific Examinations, Tests and Medical Instruments

Section 1 Specific Medical Instruments

Section 2 Laboratory development and testing for specific inspections and inspections

Chapter IV Supplementary Provisions

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