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

Product Registration

Registering a medical device in Indonesia involves navigating a regulatory process overseen by the Ministry of Health of Republic of Indonesia. Medical devices are classified into different categories based on risk levels (e.g., Class A, B, C, D). The classification impacts the type and depth of the regulatory requirements.

Medical Device Company Establishment Service

In Indonesia, a local distributor of medical devices must act as a legal entity authorized to handle the distribution and regulatory responsibilities associated with medical devices, commonly in the form of a Perseroan Terbatas (PT), a limited liability company. Various factors, such as the selection of KBLI, IDAK, GDPMD, etc, can significantly affect fluency in the medical device business.

Renewal and License Amendment

In compliance with regulation PMK 62/2017, the license approval extension is carried out a maximum of 9 months before the license period ends.

Miscellaneous Certificates

This certificate or letter is an exception to the product distribution permit that the company can apply for, such as a product information certificate, spare part certificate, SAS (Special access scheme), free sale certificate (FSC), etc.

Post-Marketing Surveillance

Post-market surveillance (PMS) for medical devices is crucial for ensuring ongoing safety and effectiveness once a device is on the market. The process involves monitoring the performance of medical devices, identifying potential issues, and taking corrective actions when necessary. Our service involves E-Report, product complaint and recall reporting, and FSCA.

E- Catalogue

The best strategy for entering government procurements is to assist the client in enrolling in the e-catalog with the fastest process. Typically, within 3-7 days after enrolment, your product is posted on the e-catalog portal and ready to sell.

Medical Device Trademark Management

Trademark registration in Indonesia is managed by the Directorate General of Intellectual Property (DGIP) under the Ministry of Law and Human Rights. The process ensures that trademarks are legally protected, preventing unauthorized use and infringement. In the medical device industry, the trademark certificate is commonly used for OEM products and E-catalogue submission.

GDMPD

CDAKB certification aims to guide the distribution and quality control of medical devices through the implementation of SOPs from 13 clauses, such as quality management system, resource management, storage, product traceability, complaint handling, field safety corrective actions, device return and destruction, internal audit, management review, and third-party activities.

Regulatory Intelligence

Provide real-time insights on involving regulation in Indonesia. We simplify complex laws, minimize risk, and tailor solutions for your business. Stay ahead with our trusted expertise and make compliance a competitive advantage. Please contact us to get updated regulations such as Halal implementation, Classification and Grouping, Local manufacturer information, government insurance reimbursement, and others.