Connecting your business with our regulatory experience

We consist of professionals with backgrounds from multinational medical device manufacturers who specialize in product registration for local and imported products. We at PT Deray Global Utama are dedicated to helping clients navigate the medical device registration system efficiently with high regulatory compliance.

Our Services

In terms of medical device licensing, we offer a range of advanced solutions tailored to your business needs, continually evolving to meet the requirements of the Indonesian market

We provided our client with an overview of the basic regulations and updates in Indonesia. It is known that regulations in developing countries are quickly improving in line with ASEAN harmonization. With security, control, monitoring, and post-market requirements standardized within ASEAN, there is a significant amount of consistency in dossier approval and distribution of medical device services.

Our Products

As a dedicated distributor, we specialize in offering high-quality products from leading manufacturers in the fields of natural science, life sciences, and biochemical assays. Our extensive product range includes advanced solutions for research in biology, antibodies, and various biochemical assays. It is important to note that all products provided through our distribution channels are intended solely for research purposes and are not available for commercial use. We are committed to supporting scientific research and advancing knowledge through our specialized product offerings.

Main Services

License Representative

We act as a local representative connecting foreign manufacturers with Indonesian government agencies. Our work covers medical device registration, record keeping, and prompt reporting and handling of all adverse events.

Product Registration

Medical device registration is submitted to the Ministry of Health of the Republic of Indonesia. Each device is classified as Class A, B, C, or D by risk level, and that class sets the requirements.

PT Establishment

Local medical device distributors must be a legal entity, usually a limited liability company (PT). We help select the appropriate KBLI code and arrange the IDAK and GDPMD so your business meets all applicable rules.

Renewal and License Amendment

Distribution permits are renewed under PMK 62/2017 and can be submitted up to 9 months before the permit expires. We also help amend product data on issued permits so the information stays accurate and up to date.

Miscellaneous Certificates

Besides distribution permits, we handle supporting product certificates: product information certificate, spare parts certificate, SAS (Special Access Scheme), and Free Sale Certificate (FSC). Each type has its own process.

Post-Marketing Surveillance

Post-market surveillance keeps medical products safe and effective once they reach the market. We assist with reporting through E-Report, complaint management, adverse event reporting, and product recall (FSCA) when it is needed.

E-Catalogue Procurement

A strategy to win government procurement through the e-catalogue. After registration, your product is usually uploaded to the LKPP-managed e-catalogue portal within 3-7 days and ready to sell to government agencies.

Medical Device Trademark Management

Medical device trademark registration is handled by DJKI under the Ministry of Law and Human Rights. Trademark protection prevents unauthorized use and infringement, including for OEM products and e-catalogue use.

GDMPD

CDAKB certification guides the distribution and quality control of medical devices through SOPs covering 13 clauses. Its scope includes quality management, storage, product traceability, complaint handling, and internal audit.

Regulatory Intelligence

We provide up-to-date information on the medical device regulations in force in Indonesia. We simplify complex rules, identify and reduce risks early, and tailor practical solutions to your business needs.