Medical Device Company Establishment Service

As a developing country, Indonesia continues to increase its capacity in various fields including medical device companies. The increasing number of owners of companies, small and large, has made Indonesia one of the investors to consider investing in Indonesia. The main form of business vehicle used in Indonesia is the PT. A PT is a legal entity comprised of shares that must be established by at least two shareholder. The PT is most common form of business vehicle because of the limited liability of shareholder and a clear capitalisation of regime. A PT can be a publicity-listed company or a privately-own company.

A PT Is a legal entity that functions to carry out business activities with authorized capital in the form of shares. The laws and regulations and provisions of Article 1 paragraph 1 of Law Number 40 of 2007 which regulates a PT must be complied with by all business activities. Privately-own PT is a limited liability company formed by 1 (one) individual solely as a shareholder and director in accordance with Job Creation regulation to serve the needs of micro and small companies.

A PT is considered a type of entity that usually has at least two owners. There are several conditions that must be fulfilled in order to establish an Private-own PT, including:

• Minimum 2 shareholders, 1 director and 1 commissioner

• A minimum age of 17 years is required.

• Only one Private-own PT can be established in a year.

• Understand Indonesian Law

• Must be an Indonesian national.

Legal Entity
In the first stage, you can prepare the name of the company that you will register. To check the availability of the PT name, whether it can be used or if someone has already used it, you can see it at https://ahu.go.id/The determination of the name for the PT company in Indonesian and with the modan and founder being Indonesian citizens, the name for the PT consists of 3 syllables. Norm provisions apply to the naming of PT.

The next stage of creating a legal entity is to find a suitable office location for the company. After having a location that will be made into a legal entity, the applicant can contact the local notary to make a company deed and ratification of the AKTA at the Ministry of Law and Human Rights. The notary will take care of the AKTA, AKTA ratification, NPWP, SIUP/IUT, domicile, and TDP depending on the request to the notary. After that, the applicant can make PKP (Taxable Entrepreneur) and SPPKP (Taxable Confirmation Letter). The notary will take care of the tax office, or Deray Global Utama can help take care of this.

Companies that take part as distributors of medical devices in Indonesia must have a Medical Device Distributor Approval (IPAK). An IPAK is obtained after the company has a NIB (Business Identification Number).

Making NIB (Business Identification Number) is obtained by registering in the Online Single Submission (OSS) system. OSS is used for customs access (API-U/General Import Identification Number and NIK/Customs Identification Number) for import activities and recommendations for Medical Device Distributor Approval (IPAK).

Medical Device Distributor Approval (IPAK)
IPAK management is carried out after getting the Business Identification Number (NIB) issued because the Ministry of Health will ask for the NIB automatically when submitting an IPAK application. There are several requirements and required documents for an IPAK application. Deray Global Utama can help you get everything ready.

IPAK is categorized into 5 for distribution needs, namely:

• Non-Radiation Electromedical Medical Devices.

• Radiation Electromedical Medical Devices.

• Non-Radiation Electromedical Medical Devices.

• Non-Radiation Electromedical Medical Devices.

• In Vitro Diagnostic Products.

Each IPAK category must have a Technical Person in Charge (PJT). The IPAK category affects the needs and requirements for the PJT criteria. Examples of IPAKs that are permitted to distribute include Non-Radiation Electromedical Medical Devices and Non-Sterile Non-Electromedical Medical Devices. These are required for PJTs who have a D.III-Electromedical Engineering degree. To meet the IPAK category, the applicant must prepare a workshop room for the IPAK category of Non-Radiation Electromedical Medical Devices and Radiation Electromedical Medical Devices.

The Indonesian Ministry of Health will conduct an audit of the Warehouse and Workshop in the IPAK certification process. Deray Global Utama can assist in the audit process until the IPAK is published.


The medical device legal entity establishment process in Indonesia has its own challenges where this commodity having high demand with various regulations regulated by Ministry of Health. Deray Global Utama can assist you provide company establishment services with our experienced we have for local and foreign company. Please contact us for more information.