A foreign manufacturer can set up a legal subsidiary entity in Indonesia with full investment. Alternatively, appointing a Local Authorised Representative (LAR) is also an option for registering and marketing medical devices. The LAR acts as a liaison with the Ministry of Health, ensuring that all regulatory requirements are met efficiently.

A LAR has the local expertise and understanding of regulatory procedures, helping to navigate complex documentation and submission requirements. This streamlines the registration process, reducing the risk of delays and rejections.

An LAR provides valuable insights into the Indonesian market, including regulatory changes, local standards, and best practices. This knowledge helps manufacturers adapt their products and strategies to better fit market demands.

The LAR is responsible for post-market activities, including monitoring device performance, handling adverse event reporting, and ensuring ongoing compliance with local regulations, which is crucial for maintaining market authorization.

As a local point of contact, the LAR facilitates effective communication with Indonesian regulatory authorities, helping to resolve issues quickly and ensure timely responses to any regulatory inquiries or requirements.

The LAR assumes legal responsibility for the device within Indonesia, handling product recalls, safety alerts, and regulatory audits. This reduces the manufacturer’s legal risks and ensures local accountability.

Having a reputable LAR enhances the credibility of your brand in the Indonesian market, reassuring healthcare providers and patients that your devices are backed by local expertise and support, which can lead to increased trust and market acceptance.