Singapore Medical Device Registration

Qserve is your regulatory consultancy partner for medical device registration services in Singapore.

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.
 
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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.

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Market access Singapore

Do you want to learn more about Singapore market access and its regulation?

We help you with a quick overview of:

  • The Singapore medical device regulation process
  • Classification system
  • Regulatory requirements
  • Registration/Evaluation routes (general or customized to your device)
  • License holding options
  • Important guidance links

Market access Singapore

How Qserve can help

Meet our global registrations team to talk about our services:

  • Regulatory market access strategy
  • Registration support in Singapore
  • Singapore Registrant support
  • Technical documentation gap analysis
  • Classification assessment
  • Translation labels and IFUs based on requirements
  • Gap analysis
  • Risk management
  • Clinical evaluation
  • Post-market surveillance
  • Vigilance reporting

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