Local Authorised Representative in Singapore
Local Authorised Representative in Singapore
As a trusted Local Authorised Representative (LAR) in Singapore, we provide the local expertise and regulatory support you need for seamless market entry and continued compliance. We take care of the details such as submissions, notifications, and ongoing regulatory obligations so you can focus on delivering your medical innovations to healthcare providers and patients across Singapore.
Trusted Singapore Authorized Representative for HSA Registration & Regulatory Compliance
Expanding into Singapore’s advanced healthcare market and need a reliable regulatory partner? Foreign manufacturers without a local presence must appoint a Local Authorised Representative (LAR) to act as their official in-country regulatory contact. The LAR ensures your products comply with Singapore’s Health Sciences Authority (HSA) requirements and supports your regulatory obligations throughout both the registration and post-market phases.
At Andaman Medical, we provide the local regulatory expertise needed to navigate Singapore’s structured approval pathways with confidence. Our team manages submissions, licence applications, communication with the HSA, post-market surveillance, adverse event reporting, and all ongoing compliance activities required to maintain access to Singapore’s highly regulated medical device market.
Why Appoint a Local Authorised Representative in Singapore?
- Meet mandatory HSA requirements for foreign manufacturers
- Ensure accurate, timely communication with regulatory authorities
- Navigate submission and approval procedures with local, up-to-date expertise
- Maintain long-term compliance through organised post-market and vigilance activities
- Support your presence in one of Asia’s most trusted and well-regulated healthcare systems
Streamlined Registration Process
Streamlined Registration Process
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.
Regulatory Compliance
Regulatory Compliance
A LAR ensures that all requirements set by Singapore’s Ministry of Health are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
Efficient Communication with Authorities
Efficient Communication with Authorities
LARs act as a direct communication link between the company and Singapore’s regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Up-to-Date Knowledge of Regulatory Changes
Up-to-Date Knowledge of Regulatory Changes
LARs keep companies informed about the latest regulatory updates and policy changes in Singapore, ensuring ongoing compliance and helping to adapt strategies quickly when needed.
Faster Market Access
Faster Market Access
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into Singapore market and enabling companies to start selling their medical devices sooner.
Local Representation for Product Issues
Local Representation for Product Issues
A LAR is responsible for handling post-market surveillance, adverse event reporting, and product recalls, providing a local point of contact for regulatory authorities, which is crucial for ongoing market access.
Requirements for a Marketing Authorization Holder or Local Authorised Representative (LAR) in Singapore
CRIS Company Account and Dealer Licence
- The LAR must have a Client Registration and Identification Service (CRIS) company account from the Health Sciences Authority (HSA).
- The LAR must possess a dealer licence according to their activity, which could be a Manufacturer’s License, Registrant's Licence, Importer’s License, or Wholesaler’s License (import and export).
- Only Singaporean companies can apply for a Registrant Account.
Letter of Authorization
- A Letter of Authorization (in the prescribed format) from the foreign manufacturer is required for all products and models of devices to be registered.
- The Letter of Authorization must be issued on the Product Owner’s letterhead, with a physical signature or digital-traceable signature.
Multiple Marketing Authorisation Holders
- Yes, multiple Registrants are allowed in Singapore.
- Each Registrant must register the device individually. Each registration is treated as a new device application, and registration fees apply each time.
Process to Change Registrant
- Registrants can be changed by applying for a Change of Registrant.
- The turnaround time for this process is 40 working days.
- The HSA fee for a Change of Registrant application is S$880 per application.
Why Choose Andaman Medical?
