HPA and Health Products Regulations 2010
Medical Device Registration in Singapore
Qserve’s experts guide manufacturers through the medical device registration process in Singapore, including in vitro diagnostics (IVDs), with the Health Sciences Authority (HSA) using the Medical Device Information Communication System (MEDICS) database.
Singapore is a thriving healthcare market that focuses on innovation and digital health devices, making it an attractive entry point. Manufacturers can leverage overseas approvals to streamline the approval process and achieve compliance more efficiently.
Qserve ensures a smooth registration process by helping you navigate regulatory requirements, lodge overseas approvals, and meet HSA standards. Our team works closely with you to ensure your product complies with all necessary regulations, enabling a seamless market entry into Singapore.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
Do you need assistance with medical device registration in Singapore or a go-to-market strategy?
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Regulatory Compliance in Singapore
How Qserve Supports Medical Device Registration in Singapore
Qserve’s regulatory consulting specialists have comprehensive experience with the Singapore medical device market. We understand Singapore’s regulations and assist with the various conformity assessment routes, especially for manufacturers with existing overseas approvals. Our team works with you to develop a tailored strategy to enter the Singapore market efficiently.
If you already have a strategy, we provide hands-on support to bring it to life. Our experts assess your current technical documentation, identify gaps, and guide you on how to make it Singapore-ready. We also prepare your submission file to ensure compliance with Singapore’s regulations.
With a deep understanding of APAC countries’ regulations, our international team simplifies the registration process and helps you confidently achieve market access.
Trust Qserve to streamline your medical device registration in Singapore and support your growth in the APAC region.
Benefits of Qserve engagement
Worldwide medical device and IVD registration
Qserve is a leading regulatory consulting firm specializing in medical devices and in vitro diagnostic (IVD) regulatory and quality affairs. We provide tailored solutions to help manufacturers achieve and maintain market access worldwide.
Why Choose Qserve?
Our team has in-depth knowledge of the regulatory requirements in various markets, ensuring your product complies with local and international standards.
We assist with all aspects of medical device and IVD registration, including:
- Regulatory strategy development
- Documentation preparation and submission
- Compliance with quality standards and regulations
Our regulatory and quality experts are highly skilled in navigating complex regulatory landscapes and guiding manufacturers through every step of the process.