• Indonesian

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
Indonesia-Medical-Equipment3

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.

Check our Medical Distribution License in Indonesia – IPAK

 

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.

Contact our consultants

 

Selected Testimonials

  • logo-PT-Asia-Victory

    Prior to choosing Cekindo as our business partner in Indonesia, we interviewed and compared several companies. Finally, we chose to cooperate with Cekindo because of its professionalism and quality. Cekindo has assisted us in many ways, from company certification application to KITAS application and financial statement compliance to the fulfillment of other tax obligations in Indonesia. We appreciate the team’s fast response and professionalism in preparing the financial statements, among others.

    Doris Chen
    PT. Asia Victory and PT. Bigger One
  • logo Toaster

    When I joined Toaster, it was already working with Cekindo. But it’s quick to see why Toaster chose Cekindo. Cekindo has been very helpful throughout. Toaster Headquarters is based in London. Indonesian tax laws are not our specialty. Cekindo’s team has helped us to understand Indonesian tax. They are very knowledgeable and dependable, and therefore a huge asset to our company.

    Tsui-Sie Wong
    Toaster
  • 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
    Hydropol
  • 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
    Bristlecone

Selected Clients

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logo-isoline
logo-amazeskin
logo-eizo
logo-HB2
logo-henkel3
logo-marmon2
logo-smt2
logo-sterylab2
logo-arcadia
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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?