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Medical Devices Registration in Indonesia

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Being a developing country, Indonesia lacks domestic medical devices of high quality, and foreign equipment is needed. Even though 95% of the registered medical supplies in Indonesia come from overseas, the market remains underserved, and it is expected that stable market growth of 15% will continue during the upcoming years. Check the Import-Export statistic of Medical Devices in Indonesia, below:

Medical Device in Indonesia

The medical industry in Indonesia ranks as one of the most profitable and attractive fields for foreign entrepreneurs. The government imposes several regulations that should prevent market entry of potentially dangerous substances and devices, and other non-registered medical products from being imported and sold in Indonesia.

The main control bodies that ensure safety and compliance are the Directorate General of Pharmaceutical Services & Medical Devices, Ministry of Health of the Republic of Indonesia, and Directorate of Medical Device Production and Distribution Development, with the primary agency called National Agency of Drug and Food Control (NA-DFC) also known as Badan Pengawas Obat dan Makanan (BPOM).

Medical Equipment Registration with Cekindo

Infographic Business Incorporation Indonesia

Start a Company

By law, international companies are not entitled to register and distribute medical instruments in Indonesia. Only legal companies registered in Indonesia and classified under distributor can be used for these purposes. Notably, according to the Negative Investment List, the maximum foreign ownership of 49% is allowed.

Cekindo provides nominee services and helps incorporate a fully-owned foreign-company as your maximum foreign share will be complemented with shares held by Cekindo.

Another option of how investors can quickly penetrate the Indonesian market is to purchase a ready-made shelf company.

Nominee Product Holder

By registering medical products under Cekindo, foreign investors do not need to incorporate their own legal entity in Indonesia. Based on the sale nominee agreement, your products will be registered under an independent third party that holds a Medical Distribution Licence in Indonesia (IPAK) such as Cekindo.

You can see our Medical Distribution License in Indonesia – IPAK here


Register Medical Devices

Infographic-Product-Registration Medical Devices IndonesiaDue to the harmonisation of the Indonesian grade-evaluation system with the rest of ASEAN, the classification of the medical product in Indonesian is now divided into four categories, and the registration process becomes more complicated with each class.

For example, class D medical equipment has to go through a long process of evaluation with clinical tests, articles in published journals and risk analysis.

However, even registered products are not entitled to enter the Indonesian market unless they are granted the Distribution License for Medical Devices.

The paperwork related to the registration of medical goods in Indonesia is challenging, and both licences require in-depth knowledge of processes. Cekindo can submit the application dossier on your behalf to avoid delays in the procedures.

Extension of the Distribution Medical Equipment Licence

The validity of the distribution licence is five years. In case, foreign manufacturers and distributors decide to extend the licence, it should be done at least nine months before it expires. Contact Cekindo to extend your license before its validity expires and avoid re-registration of your medical equipment.


Fill in the form below and get the updated information on medical devices registration in Indonesia.
Our legal teams are available offline as well. Visit us in our offices located in Jakarta, Semarang, Bali, and we will be happy to answer your questions.

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Selected Testimonials

  • logo Ohmnia

    As a new business in Indonesia, we started consulting with multiple law firms but quickly narrowed down to only Cekindo. Cekindo was recommended as one of the top firms by multiple sources in the business community. The staff at Cekindo was very responsive to our needs as a new business. The team provided consultancy and assisted our startup firm with initial business setup, licenses and permits, HR/recruitment and market research. One year since our establishment, we still consider Cekindo as our partner.

    PT Ohmnia Tenaga Surya
  • Jan Pilar - Hydropol

    When we intended to enter the Indonesian market back in 2013/14, Cekindo helped us to understand the possibilites and options for business presence in Indonesia through legal advice & also advisory on how to arrange for ownership. Furthermore, Cekindo also provides us with a range of fully professional and reliable accounting & tax services for our representative office in Indonesia. In the world of digital & virtual economy like today, it is an essential prerequisite to have the most reliable business partner like Cekindo.

    Jan Pilař
  • Sagar Datar - Bristlecone

    A huge gratitude to Cekindo, particularly its visa team, for handling our visa cases. During our visa applications, Cekindo was extremely helpful not only in facilitating all of our visa requirements but also in clarifying our queries/doubts. I would like to take this opportunity to acknowledge and appreciate the good work of Cekindo’s visa team.

    Sagar Datar
  • Matthias Coessens - Empyrean

    When I was looking for a reliable partner who could help with company registration, payroll, taxes and working permit in Indonesia, Cekindo’s domain knowledge and clear communication astonished. Firstly, we decided to pursue cooperation with Cekindo in terms of company registration, but they also assisted me in obtaining the necessary working permits and visas (KITAS), and we use their payroll and tax reporting services until now.

    Matthias Coessens
    Product Director at Empyrean Solutions Apac
  • Ivana Bartonkova

    Cekindo handled business visa for our new colleague promptly and made the start of our company in Vietnam easier and faster. I particularly enjoyed communication with the consultant, who advised the best solution for us and was all the time available to answer any questions. She made sure that all the documents were collected and prepared on time and we got great support during the whole process. Thank you Cekindo and I hope to cooperate again in the near future!

    Ivana Bartonkova
    Marketing and HR director of Port Cities Vietnam
  • Phyto CZ Sro

    Cekindo assisted us with a selection of our local distributor in Indonesia and organised several meeting in Jakarta. Their assistance enabled us to meet our potential local partners and choose the best distributor conveniently. The decision to cooperate with Cekindo was based on a recommendation from our prominent partner in Bali and we cannot be more grateful. Cekindo’s systematic work, active communication, thoroughness and professionalism was exceptional.

    Ing. Václav Tomek
    Phyto CZ Sro
  • Vivek Singh Rathaur

    Cekindo initially helped us with setting up our business structure in Indonesia and getting us all due licenses and approvals. Currently, Cekindo is associated with us as our business partner in Indonesia by providing a face to our name and handling various business activities on our behalf. Without their help, we would be lost in keeping up with regulatory requirements and being a compliant company in Indonesia.

    Vivek S.Rathaur
    Vega Industries
  • akvo - cekindo

    Thanks to Cekindo and its one-stop market entry solutions, we could start exploring the Indonesian market. Cekindo’s broad portfolio of services included a formal process of our representative office registration, consultations regarding proper legal set-up and even working permit and visa applications. Cekindo’s extensive knowledge of the latest developments and legal requirements allowed us to focus on more operational matters and to build a local team in Indonesia.

    Peter van der Linde
    Co-founder / Director strategy & solutions, Akvo Pte Ltd
  • morning-star-cekindo

    After extensive research online, I reached out to several companies including Cekindo. Cekindo’s info package and summary of services were by far the most thorough and professional and their pricing was competitive and reasonable. Cekindo’s sound knowledge of all administrative requirements gave me the confidence that my company incorporation of 100% foreign owned export company was being executed correctly and legally.

    Kingsley Fiegert
    Director, Morning Star Investments (WA) Pty Ltd
  • Jason Peter Stevens

    With knowledgable team, Cekindo helped me make the whole process of company registration and product registration of health and beauty products in Indonesia less confusing and seamless at the same time. They have always been swift in response and hands-on at every email, never leaving me wondering or worried. As far as I am concerned, they go above and beyond the call of duty. They will most certainly be my long-term partner moving forward into the years to come. Thank you Cekindo!

    Jason Peter Stevens
    Group CEO, Studio XII Pte Ltd

Selected Clients


Frequently Asked Questions

How long will it take to register a medical device?

What if I do not want to set up a company in Indonesia, will it still be possible to export medical devices?

How long will the medical device license be valid?

What documents should I prepare for medical device registration in Indonesia?

Is there any special license to distribute the medical devices?

What are the risk categories of medical devices in Indonesia?