Licensing for Healthcare Equipment Manufacturing

Business The licensing process for Healthcare Equipment Manufacturing Business in Indonesia is carried out through OSS RBA (Online Single Submission Risk-Based Approach), which automatically sends notification of the issuance of the NIB (Business Identification Number) to the Ministry of Health or the DPMPTSP of the province, DPMPTSP of the district/city, and the KEK (Special Economic Zone) administrator according to their respective authorities. The notification includes the NIB, Business Registration Certificate/Standard Certificate/Healthcare Equipment Industry Permit based on the Low, Medium, or High-Risk category.

For Low-Risk NIB, the business entity must fill out a statement of commitment for environmental management and monitoring (SPPL) and subsequently receive the NIB, which also serves as the SPPL based on the statement of commitment for environmental management and monitoring.

For Medium-Risk NIB, the business entity must fill out a statement of commitment to meet the standard requirements of business activities and/or fill out the UKL-UPL form along with a statement of commitment for environmental management or fill out the SPPL form available in the OSS System to obtain the NIB and Standard Certificate as legal documentation for the preparation, operation, and/or commercialization of business activities.

For High-Risk NIB, the business entity must fill out the UKL-UPL form along with a statement of commitment for environmental management available in the OSS System to obtain the NIB and Standard Certificate, indicating that it is not yet verified as the legal status for business preparations. In addition to the NIB, the High-Risk NIB also requires the business entity to have the Standard Certificate and operational permit. Furthermore, for business activities, an Environmental Impact Assessment (Amdal) is mandatory, and before applying for the permit, the business entity must obtain Environmental Approval in the form of a decision on environmental feasibility.

The Business Identification Number (NIB) also serves as a general import identification number for trading imported goods or as an import identification number for self-used imported goods such as capital goods, raw materials, auxiliary materials, and materials to support the production process (must choose one), customs access rights, registration of business participant for health social security and employment social security, and mandatory labor reporting for the initial period of the business entity.

To obtain the Business Identification Number (NIB), the business entity must complete the following:

a. Business entity data, including:

• Business name and type of business entity.

• Certificate of establishment number or registration number along with its validation.

• Correspondence address.

• Planned capital amount.

• Management and shareholder data, including the country of origin of the investor for foreign direct investment (if applicable).

• Purpose and objective of the business entity.

• Business entity telephone number.

• Business entity email address.

• Taxpayer Identification Number (NPWP) of the business entity.

b. General Business Activity Plan, including:

• Business sector according to the Indonesian Standard Industrial Classification (KBLI).

• Business location.

• Customs access.

• An importer identification number to be selected.

• Commitment to participate in health and employment social security.

• Labor reporting status.

c. Business Location Plan, including:

• Business location address, including the village, sub-district, district/city, and province.

• Required land area for spatial utilization activities (m2).

• Land ownership information, whether owned, leased, borrowed, or previously used.

• Location coordinates (latitude and longitude) are depicted in a polygon shape that provides information on area and shape.

• The planned building area and a number of floors according to the spatial utilization plan for building construction.

• Planned number of buildings, including buildings for product/service capacity and/or infrastructure required to support business activities.

Business Permit to Support Business Activities (PB-UMKU)

Healthcare Equipment Manufacturing businesses choose the main business activity according to the KBLI in the business permit to support business activities, as regulated by the Minister of Health Regulation No. 14/2021 on Business Activity and Product Standards in the Risk-Based Healthcare Sector Business Licensing. The OSS system sends notification of the application to the Ministry of Health/institutions, DPMPTSP of the province, DPMPTSP of the district/city, KEK administrator, and the KPBPB Development Agency according to their respective authorities.

Accelerated Permit Issuance

Accelerated Permit Issuance is granted to businesses with a high-risk level, located in KEK, KPBPB, and Industrial Zones, to carry out preparatory, operational, and/or commercial activities while still required to fulfill the applicable permit requirements mutatis mutandis.

PT INSPIRY INDONESIA KONSULTAN is here for you, DIAGNOSTIC IN VITRO HEALTHCARE EQUIPMENT MANUFACTURER, as a reliable partner in providing assistance for Healthcare Equipment Manufacturing Company Licensing and Guidance in obtaining Good Manufacturing Practice for Medical Devices (CPAKB) Certificate. Our support includes:

1. Preparation of legal documents.

2. Preparation of 48-50 Standard Operating Procedures and over 100 forms.

3. Work assistance socialization.

4. Internal audit socialization.

5. Internal audit guidance.

6. Opening-closing Corrective and Preventive Action (CAPA).

7. Submission to OSS-RBA.

8. External audit.

9. Opening-closing CAPA for external audit.

10. Issuance of CPAKB certificate.

Through our experience, dedication, and commitment, we are ready to assist you. Together, let's collaborate to strengthen the Healthcare Equipment industry and drive Indonesia's economic growth. Click here.