Our Services
Our Services
In terms of medical device licensing, we have services with various solutions for your business that are increasingly advanced and developing in the Indonesian region.
In the initial stage, we presented to our client the basic regulations and updates in Indonesia, as it is known that regulations in developing countries are accelerating towards perfection with ASEAN harmonization. With security, control, monitoring and post market requirements standardized with ASEAN, there is a lot of uniformity in dossier approval and distribution of medical device services.
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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
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.
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