Medical Device and Therapeutic Products Registration with Health Sciences Authority (H.S.A), Singapore
We provide seamless product registration support across all classifications with Singapore’s Health Sciences Authority (HSA), acting as your Product Registrant. Supporting global and regional companies, we specialize in medical device, IVD, SaMD, and therapeutic product registration, ensuring compliance and smooth market entry. Our experienced in-house team expertly manages regulatory submissions across all risk classifications.
Authorized Registrant as Local Authorized Representative
We offer services as an authorized registrant and local representative, ensuring the holding and annual retention of licenses.
Post-market surveillance and regulatory compliance maintenance
We manage change notifications and amendments to product registrations, ensuring compliance with evolving regulations. Our safety monitoring and reporting services cover complaint handling, adverse event reporting, and Field Safety Corrective Actions (FSCAs) to maintain product integrity and patient safety.
Medical Device Product approvals in the global market
- Australia – Therapeutic Goods Administration (TGA)
- Thailand – Food and Drug Administration (FDA)
- Malaysia – Medical Device Authority (MDA)
- India – Central Drugs Standard Control Organization (CDSCO)
- European Union – Conformité Européene (CE) Mark
- United States – U.S Food and Drug Administration (US FDA)
- United Kingdom – UK Conformity Assessed marking (UK CA)
- Cananda – Health Canada
- Gulf Cooperation Council (GCC) [Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE)] – Gulf Health Council (GHC)
- Development of regulatory strategies and Preparation of Technical Documentation and submissions for CE marking under MDR/IVDR, as well as FDA 510(k) and PMA applications. Support for FDA interactions, including Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications.
- Post-market surveillance and regulatory compliance maintenance to ensure continued adherence to regulatory standards. Post-market clinical follow-up (PMCF) and real-world evidence (RWE) studies to support ongoing product evaluation.
- Guidance on WHO Pre-Qualification for in vitro diagnostic (IVD) devices to meet global health standards.
Digital Health
- Guidance on information security and data protection compliance, including regulations such as GDPR and HIPAA. Risk assessment and mitigation strategies for digital health technologies to ensure regulatory compliance and operational security.
- Implementation of management systems for information security (ISO 27001), privacy information (ISO 27701), and artificial intelligence (ISO 42001). Training and advisory services on artificial intelligence (AI) and machine learning (ML) applications in life sciences.