Based on the Annex to the Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector ("Permenkes No. 14/2021"), a clinic is a health service facility that provides comprehensive basic medical and/or specialist services.
When viewed in terms of the organizers, the clinic business can be divided into 2 (two) types, namely:

• Government Clinics, namely clinics organized by the Government, local governments, government agencies, TNI and POLRI; and
• Private Clinics, which are clinics organized by the community, both individuals, business entities and legal entities.

Meanwhile , when viewed in terms of service capabilities, clinical businesses can be classified into 2 (two) forms;

• Pratama Clinic, which is a clinic that provides basic medical services; and
• Main Clinic, which is a clinic that provides specialist medical services or basic and specialist medical services. The main clinic's specialist medical services are organized based on organ systems and / or branches / disciplines in one or more specialist fields.

In the context of providing services, clinical businesses can be classified into 2 (two) types, namely:

• Outpatient clinic, which is a clinic that provides patient services for observation, diagnosis, treatment, medical rehabilitation and other health services without staying overnight;
• Inpatient clinic, which is a clinic with patient services for observation, diagnosis, treatment, medical rehabilitation and other health services by staying overnight.

In terms of capital ownership, a clinical business can take the form of a Domestic Investment Clinic (PMDN) or a Foreign Investment Clinic (PMA). According to the general requirements stated in the Annex to the Minister of Health Regulation No. 14/2021 concerning Clinical Business Standards, thePMA Clinic is required to take the form of a Main Clinic with the status of a legal entity in the form of a Limited Liability Company. While the PMDN Clinic is in the form of:

1. 1. Government Clinic, must have the status of a public legal entity;
   2. Private Clinic with:

• • • Outpatient Services can have the status of an individual, business entity, or legal entity.
    • Inpatient Services can have the status of a business entity or legal entity.

Article 10 paragraphs (1) – (2) of Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing ("PP No. 5/2021") stipulates that based on the assessment of the level of danger, assessment of the potential occurrence of danger, the level of risk, and the scale rating of business activities, a business activity can be classified into:

• Business activities with a low level of risk;
• Business activities with a low medium risk level;
• Business activities with a medium high level of risk; and
• Business activities with a high level of risk.

Based on Annex PP No. 5/2021, both Government Clinical Activities (KBLI No. 86104) and Private Clinical Activities (KBLI No. 86105) with the scope of activities of all primary and main clinics, are classified as business activities with a medium high risk level. Therefore, the business license needed is a Standard Certificate. The period of fulfillment of business licenses for the two business activities in question is 20 days with a licensing validity period of 5 years.

Meanwhile, in the Annex to permenkes No. 14/2021 concerning Clinical Business Standards, both Government Clinical Activities (KBLI No. 86104) and Private Clinical Activities (KBLI No. 86105) are required to meet the general and special requirements of business licensing through the OSS (Online Single Submission) system. The general and special requirements in question include:

1. Clinic Profile which includes the full name and address, vision, mission, organizational structure and time of clinic implementation;
2. Clinical self-assessment which includes clinical service capabilities, medical support services (pharmaceuticals and laboratories) fulfilling the requirements of facilities, infrastructure, equipment, and human resources;
3. List of facilities, infrastructure, buildings, equipment and lists of medicines and consumables;
4. List of clinical human resources names in accordance with the authority and competence and organizational structure;
5. License to Practice (SIP) document for all health workers working in the Clinic;
6. Cooperation agreement document for the disposal of hazardous and toxic waste (B3);
7. A certificate from the district/city health office regarding consideration of approval for the establishment of the Clinic (optional for clinics with new permits);
8. Clinic's standard business certificate or a valid clinic operating license (optional for clinics with renewal or change of licensing);
9. A statement of replacement of legal entity, name of the clinic, capital ownership, type of clinic and / or address of the clinic signed by the clinic owner (optional for clinic owners with changes in licensing);
10. NIB change documents (optional for Clinics with changes in licensing related to replacement of legal entities) and
11. Permit to Hire Foreign Workers (IMTA) (optional if there are Foreign Citizen Workers (TK-WNA).

Within a period of 1 year and 3 months, business actors who carry out Government Clinical Activities (KBLI No. 86104) and Private Clinic Activities (KBLI No. 86105) are required to:

1. Registering klinik;
2. Organizing klinik health services in accordance with applicable standards;

Based on the Annex to the Minister of Health Regulation No. 14/2021 concerning Clinical Business Standards, clinics are required to have facilities, infrastructure, equipment, and procedures to ensure the quality of services, ensure the safety, health, and occupational safety of clinic workers (health and non-health workers), and control and handle the resulting medical waste (excluding transportation, processing, and destruction). The clinic is also obliged to ensure and maintain environmental conditions (water sources, water quality, water adequacy, and air circulation), as well as electrical supplies to ensure the quality of services at the clinic. In addition, clinics need to have examination equipment and supporting equipment for health services that are clean, well maintained, and qualified and calibrated. A clinic has at least a functional area consisting of:

• reception room;
• medical service room;
• medical support rooms; and
• non-medical support room.

3. Reporting the results of health service activities in accordance with applicable regulations
4. Update the data in the event of a change in the data.

Annex to permenkes No. 14/2021 concerning Clinical Business Standards allows for lengths and changes to clinical standard certificates, namely by attaching:

• A valid Business License;
• a statement of replacement of legal entity, name klinik, ownership of capital, type of klinik, and / or address of klinik, signed by the owner of klinik.
• Klinik business standard certificate document or previous klinik operational license that is still valid;
• NIB amendment document; and/or
• Self-assessment of klinik which includes the ability of k linik services, medical support services (pharmaceuticals and laboratories), fulfillment of the requirements of facilities, infrastructure, equipment and human resources.

Thechange to the Scertificate of Standar Clinic is carried out in the event of changes:

1. Capital ownership (PMA/PMDN);
2. Klinik type;
3. Services from inpatient to outpatient or otherwise;
4. Additional services; and/or
5. Address klinik.

List of documents needed to obtain a Clinical Operational Permit through an online application on the PTSP website in coordination with relevant Government Institutions:

1. Application letter in which there is a statement of the truth and validity of documents & data on paper with a stamp of Rp. 6,000.00.
2. Scanned copy of colorED ID card and Family Card of the Applicant / Person in Charge
3. PT documents in general (in the form of scanned copies in color):
   - Deed of Establishment of PT and all its amendments up to the last one;
   - Ratification of PT Establishment / Approval of Amendments to Articles of Association / Notification of Changes in Company Data (in accordance with each Deed)
4. General and Special Licensing of PT (in the form of scanned colored copies):
   • Business Identification Number (NIB);
   • TIN; and
   • Business License or other Licensing.
5. Neighbor Agreement (left, right, front, back) (according to the format provided by the PTSP).
6. Environmental Documents (scanned copies in color), such as EIA / SIPPL documents.
7. Environmental Management Statement Letter / SIPPL (scanned copy in color).
8. Letter of Cooperation Agreement for the Disposal of Solid and Liquid Medical Waste with other parties who already have a Waste Management Permit from the Ministry of Environment.
9. License to Practice (SIP) doctors, nurses or other health workers (pharmacists, pharmaceutical technical personnel, ATLM, etc.) who work in the clinic (scanned copy in color).
10. Surat Izin Praktik (SIP) dokter, perawat atau tenaga kesehatan lain (apoteker, tenaga teknis kefarmasian, ATLM, dll.) yang bekerja di klinik (scanned copy berwarna).
11. Photocopy of Pharmacy / Laboratory / Other Service Permit (if you have a separate permit) – Scanned copy in color;
12. Letter of appointment as the doctor in charge of the owner of the clinic.
13. A statement letter on paper with a stamp of Rp. 6,000.00 from the clinic owner stating that he is willing to obey and comply with applicable regulations in the health sector (in accordance with the format provided by the PTSP).
14. Statement letter on paper with a stamp of Rp. 6,000.00 from the clinic owner stating that he would not do:
    • Abortion;
    • General anesthesia by inhalation and/or spinal action;
    • Non-inpatient (if the main clinic is non-inpatient)
      (according to the format provided by the PTSP).
15. A statement letter on paper with a stamp of Rp. 6,000.00 from each doctor practicing in the clinic stating the willingness to practice along with the days and hours of practice (in accordance with the format provided by the PTSP).
16. Certificates of education and training (aesthetic beauty, emergency, contraception, APN PONED, ECG, USG, etc.) organized by national educational institutions or related professional organizations recognized by the government (according to the type of services provided).
17. Letter of cooperation with the local Subdistrict Health Center.
18. Letter of Cooperation with the nearest Hospital as a patient referral.
19. Technical Proposals equipped with:
20. Organizational structure of the clinic;
    • List of manpower (health and non-health workers);
    • Site plan with the surrounding situation;
    • Clinic room plan;
    • Data on the completeness of the building or room;
    • List of medical and non-medical equipment fittings;
    • List of available drugs;
    • A list of tariffs and types of services equipped with the name of the person in charge of the service.
21. The color photo of the doctor in charge is 4x6 cm in size as many as 3 (three) sheets.
22. Proof of rent of the building:
23. Building lease agreement for a minimum of 5 (five) years;
24. A statement letter on paper with a stamp of Rp. 6,000 from the landowner / building stating that he does not object to the land or building being used;
25. Identity Card (KTP) of the owner of the land or building (Scanned copy in color).

Source:

• Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing.
• Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector.
• Regulation of the Minister of Health Number 26 of 2018 concerning Electronically Integrated Business Licensing Services in the Health Sector.
• Regulation of the Minister of Health of the Republic of Indonesia Number 9 of 2014 concerning Clinics.
• Elektronik Sektor Kesehatan.
• Peraturan Menteri Kesehatan Republik Indonesia Nomor 9 Tahun 2014 tentang Klinik.
• https://oss.go.id/