When performing cell operation, a medical care institution or commissioned institution shall ensure the suitability of the human tissue and cell sources, except for tissues and cells obtained from a cell bank established with the approval of the central competent authority.

The establishment of a cell bank shall be approved by the central competent authority. The cell bank may charge fees for preserving human tissues and cells and shall ensure the suitability of the tissue and cell sources.
The central competent authority shall establish the qualifications, application conditions and procedures, preservation items, validity period and extension of permits, revocation, changes in permitted matters, required facilities, equipment and personnel qualifications, quality management, fee review and collection, refunds, commercial use profit sharing and other compliance matters for the establishment of cell banks mentioned in the preceding paragraph.
The central competent authority shall establish the methods for determining the suitability of providers under the previous article and Paragraph 1, including selection, testing items, and other related matters.
The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the approval and other related management matters under Paragraph 1.

Providers for the regenerative medicine tissues and cells obtained by a medical care institution or cell bank establishment shall be limited to adults who are competent adults. However, this shall not apply to those clearly beneficial for treating a specific population and cannot be replaced by other subjects.
The providers must provide prior written consent before the tissues and cells under the preceding paragraph can be collected.
If the provider is a person with limited capacity or under assistance declaration, the written consent must be obtained from both the donor and their legal representative or assistant. If the provider is a person without capacity or under guardianship declaration, the written consent must be obtained from their legal representative or guardian.
If the provider is without decision-making capacity and the procedures in the preceding paragraph cannot be followed, written consent should be obtained from the following persons in order:
1. Spouse.
2. Adult children.
3. Parents.
4. Siblings.
5. Grandparents.
The written consent provided by the person specified in Subparagraphs 2-5 of the preceding paragraph shall be made by one person. If there is a disagreement among persons of the same order, preference is given to the cohabiting relative of the adult without decision-making capacity. If there are two or more cohabiting relatives, the elder is preferred; if there are no cohabiting relatives, the elder is preferred.
For providers of regenerative medical tissues or cells who are persons with limited capacity, under assistance declaration, without capacity, under guardianship declaration, or adults without decision-making capacity, as specified in the third and fourth paragraphs, the obtained written consent must be notarized to be effective.
The content of the written consent in this article and Article 20 may be fully presented and, if needed for future reference, may be made in electronic form.

Before obtaining consent under the preceding article, the following matters shall be informed:
1. The name of the institution.
2. The method of obtaining tissues and cells, the possible side effects and complications, the incidence rate and treatment methods, contraindications, limitations, and other related matters to be cooperated with.
3. The suitability criteria for providers.
4. The subsequent disposal or possible scope of use of the remaining tissues and cells.
5. The content and methods of subsidies for the providing behavior.
6. Subsequent follow-up content and methods.
7. The right to withdraw, suspend, and terminate.
8. Medical care, compensation, and handling of adverse reactions that may occur while obtaining tissues and cells.
9. Expected possible benefits and attribution.
10. Personal data protection measures.
11. Other matters announced by the central competent authority.
The methods, procedures, and other regulations for informed consent in the preceding paragraph shall be determined by the central competent authority.