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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

medical equipment IndonesiaStart 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 67% 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.

Register Medical Devices

Due 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

  • 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
  • Konstantin-Simonov

    We chose Cekindo because we considered Cekindo as a professional company with a good attitude and a streamlined business model. Cekindo met all our expectations as it created the atmosphere of accountability and transparency. The most significant added values that we received from cooperation with Cekindo are the time we saved and mistakes we avoided.

    Konstantin Simonov
    Director, PT. AEKS Konsultasi dan Integrasi
  • DESMI Testimonial - Cekindo

    Cekindo provided outstanding services in registering our representative office in Indonesia in a timely manner. Their financial services have been helping us a lot — our local employees feel secure working for our company. Cekindo became our reliable partner with quick response on our needs. Their flexibility and full support of our business in Indonesia are the main reasons to continue in our cooperation.

    Rajendra Iskandar
    Sales and Support Engineer, DESMI
  • (CFLD), Mr. Max Yang, President, Indonesian Region

    After comparing several consultants, I found Cekindo is a international and professional organization with good understanding of local market. Cekindo helped our company to set up our first Indonesian entity, and also helps with day-to-day operation.  Cekindo showed high level of professionalism. Jump start the business in Indonesia, take care of routine process, therefore we can focus more on our core business.

    Max Yang
    President, Indonesian Region, China Fortune Land Development Co., Ltd.

Selected Clients


Frequently Asked Questions

What are the risk categories of medical devices in Indonesia?

What are the benefits of using a nominee product holder for?