Licensing & Certification:

• Valid Medical License: Confirm the doctor holds an active license to practice medicine in Indonesia.

• Certification in Regenerative Medicine: Obtain any specialized training or certification in stem cell therapy if required by Kemenkes (Ministry of Health).

• Clinic/Facility License: Ensure the facility is licensed by Kemenkes.

Approval from Regulatory Authorities:

• BPOM (Indonesian FDA) Approval: Verify that the stem cell products used are approved by the Indonesian Food and Drug Authority (BPOM).

• Ethics Committee Approval (Komite Etik): Obtain approval from a local ethics committee if the therapy is part of research or clinical trials.

• Ministry of Health Permit: Confirm the clinic has a permit from Kemenkes to offer advanced stem cell treatments.

Stem Cell Source Compliance:

• Authorized Stem Cell Source: Use stem cells from permitted sources (e.g., autologous, umbilical cord, or bone marrow) in accordance with Indonesian regulations.

• Traceability Documentation: Maintain detailed records on stem cell sourcing and traceability for audits.

• Informed Consent from Donors: Ensure tissue donors gave legally valid consent.

Patient Informed Consent & Education:

• Informed Consent Form: Provide comprehensive consent forms, explaining the risks, benefits, and possible outcomes in compliance with local medical laws.

• Transparency with Patients: Ensure patients understand the experimental nature of unapproved therapies.

• Consent for Data Sharing: Get patient consent for using personal data in studies or research, in line with Indonesian data privacy laws.

Adherence to Treatment Protocols:

• Follow Kemenkes Guidelines: Apply protocols set out in Permenkes No. 32/2018, which regulates the use of stem cells in Indonesia.

• Use GMP-Certified Facilities: Ensure that all stem cell processing follows Good Manufacturing Practice (GMP) standards.

• Monitor and Report Adverse Events: Report any negative outcomes or side effects to BPOM promptly.

Compliance with National and International Laws:

• Permenkes Compliance: Ensure strict adherence to Permenkes regulations, which outline legal frameworks for stem cell therapy.

• Clinical Trials or Experimental Use: Confirm that unapproved treatments are only provided under registered clinical trials.

• WHO Guidelines Alignment: Follow World Health Organization (WHO) standards for cell therapy practices.

Ethics and Transparency:

• Patient Data Protection: Comply with Indonesia's data privacy regulations (e.g., UU ITE).

• Transparent Fees: Avoid misleading pricing or outcome guarantees in marketing materials.

• No False Advertising: Ensure that promotional claims align with approved uses by BPOM.

Insurance and Liability:

• Malpractice Insurance: Confirm that malpractice coverage applies to stem cell treatments.

• Compensation Mechanism: Establish a clear system for handling claims of medical negligence.

Clinical Trial Requirements (If Applicable):

• Clinical Trial Registration: Register trials with Kemenkes and, if relevant, on global platforms (e.g., clinicaltrials.gov).

• Trial Reporting Obligations: Submit regular reports on clinical outcomes to BPOM and the ethics committee.

Continuous Monitoring & Review:

• Patient Follow-Up: Monitor patients long-term for adverse events and therapeutic outcomes.

• Audits and Inspections: Participate in Ministry of Health audits as required.

• Stay Updated on Regulatory Changes: Keep informed of any updates to Kemenkes or BPOM policies.