REGULATIONS FOR ESTABLISHIN CLINICS IN INDONESIA

For foreign investors or international business operators wishing to establish clinics or healthcare facilities in Indonesia, several key regulations must be observed. These regulations cover the permitted business forms, licensing processes, operational standards, and specific rules regarding manpower and health technology.

The main regulations governing the establishment of clinics in Indonesia include:

• Regulation of the Minister of Health (Permenkes) Number 9 of 2014 on Clinics.
• Law Number 25 of 2007 on Investment, which regulates foreign investment in the health sector.
• Law Number 17 of 2023 on Health.
• Regulation of the Minister of Health Number 17 of 2024 on the Second Amendment to the Minister of Health Regulation Number 14 of 2021 on Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector.

1. Types of Clinics That Can Be Established in Indonesia

According to Permenkes No. 9 of 2014, a clinic is a healthcare facility that provides individual health services, offering both basic medical services and specialized care.

Clinics are categorized into three main types:

• Primary Clinics:

  • Provide basic medical services.
  • Can be general or specialized in a specific field.
  • Typically staffed by general practitioners or dentists.

• Main Clinics:

  • Offer specialized medical services or a combination of basic and specialized care.
  • Must have specialist doctors as the primary medical staff.
  • May offer additional services such as laboratory testing, pharmacy services, or advanced medical procedures.
  • Can include additional services like telemedicine, in accordance with the new regulation in Law No. 17 of 2023.

• Special Clinics:

  • Specialize in a specific field such as cosmetic surgery, dermatology, orthopedics, or reproductive health.
  • Regulations for special clinics are determined by the Ministry of Health based on the field of discipline or organ system they serve.

2. Requirements for Establishing a Clinic

Investors intending to establish a clinic in Indonesia must meet several requirements:

A. Location and Building

• The clinic’s location must comply with zoning regulations set by the local government.
• The building must be permanent and cannot be attached to a private residential home.
• Clinics can be located in office buildings, shophouses (ruko), or hospitals, but they must have a separate operational license.

B. Human Resources (HR)

• Clinics must employ medical personnel who meet the required competence standards.
• Foreign doctors and healthcare workers are allowed but must obtain work and practice permits in accordance with Ministry of Health regulations.
• Clinics must have general practitioners, specialist doctors (for Main Clinics), nurses, and pharmacists appropriate to the services provided.

Minimum staffing composition:

• Primary Clinics: At least 2 general practitioners or 2 dentists.
• Main Clinics: At least 1 specialist doctor and 1 general practitioner.

C. Medical Equipment and Pharmacy

• Clinics must have medical equipment that aligns with the services they provide.
• All medical devices must be officially registered with the Ministry of Health.
• Clinics using specific medical technologies, such as radiology equipment or devices with ionizing radiation, must obtain additional permits from the Nuclear Energy Regulatory Agency (BAPETEN).

D. Environmental Health and Medical Waste Management

• Clinics must implement a medical waste disposal system that complies with standards from the Ministry of Environment.
• A pharmacy installation must be available if the clinic provides medication.

3. Licensing Process for Clinic Establishment

Establishing a clinic in Indonesia requires two primary licenses:

A. Clinic Establishment License

New Regulations (Law No. 17 of 2023 and Permenkes No. 17 of 2024):

• Licensing is now centralized under the central government through the Online Single Submission (OSS) system.
• Licenses are issued based on Risk-Based Licensing:
  • Low risk: Only requires online registration via OSS.
  • Medium-high risk: Requires evaluation by the Ministry of Health.
• Clinics can operate as part of a healthcare service network partnership, including with hospitals or international research centers.

Required Documents:

• Applicant’s identity (individual or business entity).
• Copy of the company’s deed of establishment for business entity clinics.
• Land certificate or proof of business premises ownership.
• Environmental Impact Analysis (AMDAL) or UKL-UPL documents for inpatient clinics.
• Clinic profile, including organizational structure, list of medical staff, and types of services provided.

B. Clinic Operational License

• This license is issued after the establishment license and once the clinic meets all technical requirements.
• Valid for 5 years and renewable.

Operational License Process:

• Document verification by the local Health Office.
• On-site inspection to assess the facility’s readiness and human resources.
• Issuance of the operational license if all requirements are met.

C. License Modification Procedure

• If there is a change in ownership or location, the clinic must apply for a modification of its operational license.
• If the clinic wants to add new specialist services, it must obtain a recommendation from the local Health Office.

4. Regulations on Foreign Healthcare Professionals

If foreign investors want to bring in foreign doctors or healthcare workers, the following regulations apply:

• Foreign medical professionals are allowed to work in healthcare facilities in Indonesia.
• Practice permits for foreign medical professionals will be determined directly by the Minister of Health, no longer by the Regional Health Office.
• Clinics in Special Economic Zones (KEK) Sanur may have easier access to foreign medical professionals due to more flexible investment incentives.