Medical Device Import License in Singapore
Bringing a medical device into Singapore’s tightly regulated market? You’ll need a medical device import license issued by the Health Sciences Authority (HSA). Without it, importing, distributing, or supplying your product locally is not permitted. That’s where Nyprax Pharma comes in, as your reliable regulatory partner with the experience, precision, and local presence to ensure fast, compliant access to the Singaporean market.
What Is a Medical Device Import License?
A medical device import license is a regulatory approval that allows companies to legally import medical devices into Singapore.
Foreign manufacturers without a local office must appoint a Singapore-based importer or local representative to apply for and hold this license on their behalf.
Why Do You Need a Medical Device Import License in Singapore?
As Singapore have well-regulated framework for healthcare, no medical device can be legally imported or supplied without an approved import license issued by the HSA. Appointing a reliable license holder ensures:
- Full compliance with HSA importation requirements
- Smooth coordination with customs and local authorities
- Timely product clearances and market availability
- Reduced risk of delays, detentions, or regulatory setbacks
- Confidence that all paperwork and documentation meet regulatory standards
Whether you’re a global medical device manufacturer or an emerging health tech startup, obtaining a medical device import license is a non-negotiable step in your Singapore market strategy.
Nyprax Pharma: Your Trusted Import License Partner in Singapore
With over 30 years of regulatory experience and more than 5,000 medical devices registered, Nyprax Pharma is your go-to partner for importing medical devices into Singapore.
We act as your local license holder and regulatory guide, managing every step of the process, liaising with the HSA, and ensuring that your devices reach the market without unnecessary delays.
Explore our full Medical Devices Registration services.
Our Role in Securing Your Medical Device Import License
When Nyprax Pharma represents you as a local importer or license holder, we take care of the regulatory work, so you can focus on what matters – delivering your medical innovations to patients and providers.
Benefits of Working with Nyprax Pharma
Proven Track Record
Over 5,000 devices registered and trusted by 500+ companies across Singapore and Malaysia.
Local License Holding
We act as your official medical device import license holder, enabling market entry even if you don’t have a local entity.
Faster Market Access
Our in-depth knowledge of HSA procedures allows efficient submissions and reduced time to approval.
End-to-End Compliance
We manage every step of the importation and regulatory lifecycle.
Custom Solutions
We tailor our approach based on your product, region of origin, and business model - ensuring smooth regulatory alignment.
Who We Work With?
- Overseas medical device manufacturers
- Distributors entering Singapore without a legal presence
- Healthtech startups scaling into Asia
- Companies requiring independent license holders
- Organizations needing import representation for multiple products
The Import License Process at a Glance
- Online Submission via MEDICS:We submit your application through the HSA MEDICS system under our license entity.
- Regulatory Liaison: We respond to HSA queries and provide additional data if needed.
- Approval & Import Readiness: Upon approval, we maintain your import license and provide ongoing support for audits and renewals.
Need Support with Your Import License?
Let’s simplify your product importation and compliance process.
Contact us for a consultation today!
Frequently Asked Questions
What is a medical device import license in Singapore?
It’s an official license issued by the HSA that allows companies to legally import medical devices into Singapore.
Who can apply for a medical device import license?
Only companies with a legal presence in Singapore can apply. Overseas manufacturers must appoint a local entity like Nyprax Pharma to act as their importer or regulatory representative.
Can Nyprax Pharma act as the importer for multiple devices or brands?
Yes. We are licensed to hold and manage multiple product import licenses for various manufacturers and product types.
What happens after I get the import license?
We continue to support your post-market obligations, including renewals, HSA reporting, and license variations. Our team also advises on labeling, storage, and distribution compliance.
What are common mistakes to avoid during the import process?
Incomplete documents, incorrect classification, and non-compliance with GDP/GDPMDS requirements are common issues. Our expertise helps you avoid these and ensures smooth approvals.
How much does it cost to get a medical device import license?
Costs vary depending on product type, classification, and services required. Reach out to us for a personalized quote.
Ready to Get Medical Device Import License in Singapore?
Let Nyprax Pharma manage the complex regulatory process while you focus on innovation.
Contact us or get a quote to speak with our regulatory specialists.