Medical Device Registration in Indonesia

Medical Device Registration in Indonesia Andaman Medical 2018-05-31T10:24:53+08:00

Market Opportunity in Indonesia

Indonesia is the fourth most populous country on earth with 257 million inhabitants and widespread demand for advanced medical equipment.

Indonesia has a significant wealth gap between social classes. In response to this, the National Health Insurance – Jaminan Kesehatan Nasional (JKN) – launched its universal healthcare program in 2014, with the goal to cover all Indonesians by 2019. This will create widespread demand for advanced medical equipment, in particular, diagnostic, medical imaging and surgical equipment.

Middle and upper income households are growing rapidly, and with the ability to afford high-value treatments (using advanced health equipment), they tend to seek private healthcare facilities. Public hospitals rarely provide this kind of treatment.

According to the latest Business Monitor International (BMI) report, the medical device market in Indonesia is currently worth US$747.3 million, and it will reach US$1,197.2 billion by 2019. It is projected to rise by a compound annual growth rate (CAGR) of 14.6%. By individual product area, the CAGRs are expected to range from 20.8% for dental products to 8.9% for consumables. In 2015, the local currency weakened against the US dollars, but it is expected that import performance will pick up on the back of rising demand for medical devices. Almost 95% of the country’s medical device market is made up of imports and 90% of medical device registrations were completed by foreign manufacturers. Therefore, the Indonesian market is still an attractive option for the commercialization of medical devices.

Andaman Medical can act as your in-country representative

Currently, foreign investors are not able to register medical devices without establishing a local office or cooperating with local distributors. A foreign-owned company is required to have a minimum capital of IDR10 billion (US$760,000). The establishment process can be complex and time consuming. To save time and effort, Andaman Medical can act as a local representative to support the launch of medical devices in Indonesia. Based in Jakarta, our team of consultants provide the necessary information on the registration process for imported medical devices and can ensure that your medical device complies with Indonesian regulatory requirements. Acting under the authority of your company, Andaman Medical will personally oversee the registration process with the Ministry of Health and obtains the distribution license after approval. Thereafter, we take responsibility as the license holder for the distribution of the medical device across Indonesia. With our support, we’ll enable your company to successfully commercialize your medical devices in Indonesia.

Services

Registrant and Importer

Regulations state that only a limited liability company (Perusahaan Terbatas, PT) that is fully equipped with a warehouse and certified technicians can register medical devices and hold the distributing license. Having fulfilled all the requirements, Andaman Medical Indonesia can act as a regulatory partner for any foreign companies who wish to sell their products in the country. As your local representative, Andaman Medical will support you in obtaining a general understanding of the medical device regulatory system in place in Indonesia. With your cooperation, Andaman Medical can walk you through each step and support you in compiling the necessary legal and technical documents required to comply with local regulatory requirements. Our team members in Jakarta are local residents and are fully versed in the process of engaging with the legal authorities in the country. Following product approval, Andaman Medical can oversee the successful import and custom clearance of your medical devices, while our network of local agents and distributors offer sales and marketing support.

Medical Device Registration

In 2014 the Indonesian government launched an integrated online system for the regulation of medical devices. All required data and documents, complying with the ASEAN Common Submission Dossier Template (CSDT), are completed within the applicant’s account on the e-Registration website. Andaman Medical utilizes a company account and is registered as a local distributor on the Indonesian Ministry of Health website. Thus, Andaman Medical can act as a local representative and distributing license holder for any foreign medical device manufacturers who wish to introduce their medical devices into the Indonesian market. Andaman Medical will personally submit the registration documents, periodically monitor the evaluation process, and rapidly respond when additional data are required. Andaman Medical Indonesia provides regulatory and distribution assistance for all medical device classifications, except for radiation-emitting devices.

Medical Device Servicing and Repair

As your authorized repair agent, we service, repair and calibrate active medical devices and monitoring equipment in our high-tech, regional service center in Jakarta, Indonesia. By providing preventative maintenance and timely, cost-effective corrective maintenance we ensure that equipment operates as designed, minimizing downtime and providing a valuable service for local medical device distributors and end users.

"Since appointing Andaman Medical as our partner, their consultants have been great in assisting us in understanding the MDA's regulations. Their service have always been prompt and professional. It demonstrates the competence of Andaman Medical. We look forward to a great long-lasting relationship with Andaman Medical."

- Jonathan Soh
Hitachi Medical

"We have been cooperating with Andaman Medical for more than a year. They are very professional, extremely organized, and prompt in responding to all our questions and queries. We appreciate the expertise of the staff and their customer-oriented attitude, and we are grateful for their regulatory support when entering new markets."

- Mojca Valjavec
Biocartis N.V.

"We are satisfied with the service we receive from Andaman Medical, their professional regulatory advice, and the monthly follow-up support. The support from Andaman Medical is always quick and clear and we are tremendously grateful for the service"

- Tetsuo Murakami
Japanese Organization for Medical Device Development, Inc.

"Good regulatory consultant to work with. The staff are knowledgable and they handle all enquiries promptly and efficiently. The client requirements/queries are rightly analyzed, and consultants provide valuable feedback. Keep up the good work!"

- Oculus Private Ltd.
Oculus Private Ltd.

"We appreciate working with Andaman Medical. We are very satisfied with your reactivity and we find you very helpful. Andaman Medical has a high level of competence and the consultants are attentive to our needs. We strongly recommend Andaman Medical and if we expand our business, we will use your services again in the Asia-Pacific region"

- Sylvain Fogola
Olea Medical