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medical device registration indonesia

Medical Device Registration Services in Indonesia

Being a developing country, Indonesia lacks domestic medical devices of high quality, and foreign equipment is needed – meaning medical device registration in Indonesia is common. 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
medical device registration indonesia - Infographic

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 the 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 Device Registration in Indonesia with Cekindo

Infographic Business Incorporation medical device registration 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 Positive Investment List, the maximum foreign ownership of 49% is allowed.

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

But if you are an investor who do not intend to form a new company from scratch, Cekindo offers you a ready-made shelf company with a clear and a good business history.

Product License Holder Service

By registering medical products under Cekindo, foreign investors do not need to incorporate their own legal entity in Indonesia. Based on the Special Purpose 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

Medical Device Registration: The Procedures

Infographic medical device registration indonesiaDue to the harmonization 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 licenses 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 license is five years. In case, foreign manufacturers and distributors decide to extend the license, 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

  • I am thankful for Cekindo, as they assisted me for several months to obtain my business visa and enter Indonesia. I was in constant contact with valuable consultants the provided me with updated information during this precarious time. Today, my being in Jakarta is not a miracle – it was made possible by Cekindo.

    Gabriel Francois Pierre Hossaert
  • Balev Coporation

    We needed an expert in applying and obtaining respective registrations for our product range in Indonesia, and a renowned German consultancy company in the safety compliance field recommended Cekindo due to their well-developed network in the Asia Pacific. Cekindo’s practical knowledge helped professionally shape and balance the wording of our labels, resulting in full compliance with Indonesian product regulations while taking into account the market and its end users.

    Rumen Myankov
    Balev Corporation
  • Tim Stewart - Photo

    I would like to acknowledge the exceptional service that PT. Cekindo Business International provided to me and my company. I needed to attend a meeting in Jakarta in October 2020 and because of the COVID-19, there were some restrictions with regard to visa application. I made the right decision by consulting with the visa team at Cekindo. The application process was expertly handled. The team ensured the visa was issued well ahead of time for my trip. I would recommend PT. Cekindo Business International to anyone looking for expert help in managing the visa application process.

    Tim Stewart
    Northern Territory Building Consultancy
  • 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

Selected Clients

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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?

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