HPA and Health Products Regulations 2010
Medical Device Registration in Singapore
Qserve’s experts can help you with medical device registration in Singapore, including IVDs with the Health Science Authority (HSA) in the Medical Device Information Communication System (MEDICS) database.
Singapore is a growing healthcare market with a special focus on innovation and digital health devices. It is an interesting entry-market because manufacturers can lodge their overseas approvals and use it to their benefit to receive approval in Singapore. Qserve guides you through a smooth process for Medical Device Registration in Singapore.
Regulatory Compliance in Singapore
How Qserve supports Medical Device Registration in Singapore
Our regulatory consulting specialists have much experience with the Singapore medical device market. We understand the regulations in Singapore and can assist you with the different types of conformity assessment routes. This is of particular interest when you already have certain overseas approvals. We can set up a strategy to enter the market with you.
Do you already know your strategy? We provide hands-on support. We can assess your current technical documentation to see if there are gaps and discuss how to make it Singapore-ready. Our international team is very experienced with medical device registration in Singapore and the regulations in APAC countries. We can also help you prepare your submission file.
Benefits of Qserve engagement
Worldwide medical device and IVD registration
- Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
- We specialize in helping clients achieve and maintain market access around the world.
- Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
- Qserve uses a practical approach to support you every step of the way.
Do you need assistance with medical device registration in Singapore or a go-to-market strategy?
Qserve is your trusted partner for global market access.
Contact us