Medical Device Registration in Singapore
Why Medical Device Registration in Singapore Matters
Singapore is known for its high regulatory standards and is often viewed as a gateway to Southeast Asia. But this also means compliance is strict and time-consuming without the right expertise. Every medical device, whether it’s a low-risk thermometer or a high-risk implant, must undergo evaluation and approval by the HSA.
Failing to comply with HSA medical device regulations can lead to delays, rejection of applications, product recalls, and serious legal consequences.
That’s why partnering with an experienced regulatory consultancy like Nyprax Pharma is essential.
Comprehensive HSA Medical Device Registration Services
Dossier Compilation and Documentation
We compile full HSA compliant dossiers for all risk classes, including product specs, clinical data, labeling, and manufacturing details to meet regulatory expectations and streamline the approval process.
Regulatory Liaison with HSA
As your local regulatory representative, we manage communications with HSA, ensuring prompt responses to inquiries, updates on application status, and smooth handling of all regulatory correspondence and requirements.
Manufacturer Support and Guidance
We work with your manufacturing partners to clarify HSA documentation requirements, guide preparation, and ensure complete, accurate submissions to prevent delays and improve first-time approval chances.
Submission via Medics System
We manage the entire Medics submission process, from account setup to final document upload, ensuring compliance with HSA’s online platform and smooth progression through each registration stage.
Classification and Grouping Strategy
We identify the appropriate HSA classification and group similar products for submission, reducing duplication and saving costs while ensuring compliance with current regulatory guidelines.
Timely Submissions and Early Bird Advantages
We prioritize early submissions to meet HSA deadlines and qualify for fee discounts, helping you minimize registration costs and ensure timely product availability in the market.
Query Management
We promptly address HSA questions during dossier review, using our regulatory knowledge to provide accurate responses, minimize delays, and ensure your application stays on schedule.
Who We Work With?
We provide regulatory support to a broad range of clients across the healthcare ecosystem, including:
- Medical Device Manufacturers (global and regional)
- Distributors and Importers
- Startups entering ASEAN markets
- Clinical and Diagnostic Equipment Suppliers
- Contract Research and Product Development Firms
Whether you’re registering a new Class B thermometer or launching a Class D implantable device, we offer tailored support that aligns with your goals and resources. Our team brings deep understanding of HSA Singapore medical device expectations to every partnership
Request a Call Back Today
Let’s talk about your medical device registration in Singapore needs. Whether you’re launching a single device or managing a full portfolio, Nyprax Pharma is your trusted regulatory partner.
Why Choose Nyprax Pharma?
When it comes to medical device registration in Singapore, not all consultancies are created equal. Here’s why companies trust us:
Cost Optimization
Our strategic device grouping and early submission planning help reduce your registration costs and shorten your time to market.
Personalized Attention
We tailor our services to your product type, business model, and regulatory history ensuring a smooth and customized experience.
Local Regulatory Experts
We’re based in Singapore and deeply familiar with medical device regulations. Our insights into local requirements help avoid delays and increase your chances of first-time approval.
End to End Service
From initial planning to post-approval support, we provide complete lifecycle management for your medical devices.
Key Documents Required for HSA Medical Device Registration
- Risk Analysis
- Executive Summary
- Device Description
- Common Submission Dossier Template (CSDT)
- Essential Principles Checklist
- Proof of Quality Management System (e.g., ISO 13485)
- Pre-Clinical Studies
- Clinical Evaluation
- Manufacturing Information
- Device Labelling & Instructions for Use (IFU)
- Declaration of Conformity
- Existing Regulatory Approvals (if applicable)
Our HSA Registration Medical Devices Process
At Nyprax Pharma, we simplify the process to ensure swift and successful approvals. Here’s how we manage it for you:
Initial Consultation & Device Classification
We evaluate your device, classify it according to HSA guidelines, and determine the required documentation for submission.
Document Collection & Dossier Preparation
Our team gathers all necessary technical documents and compiles them into a submission-ready dossier.
Submission via MEDICS
We submit your dossier through the official MEDICS platform, ensuring accurate and timely completion.
Response to HSA Queries
If HSA requests additional information, we handle the communication and provide the required clarifications or documentation.
Approval or Rejection
Once reviewed, HSA will issue either approval with conditions or rejection. We guide you through any necessary revisions or post-approval steps.
Frequently Asked Questions
How long does the HSA registration medical devices process take?
The processing time varies depending on the device classification:
- Class A: No registration required (notification only)
- Class B: ~100 working days
- Class C: ~160 working days
- Class D: ~220 working days
Nyprax Pharma ensures prompt submissions to avoid delays.
Does HSA accept medical device approvals from other countries?
Yes, devices approved by regulatory authorities like the FDA (USA), CE Mark (EU), TGA (Australia), PMDA (Japan), and Health Canada may be eligible for streamlined registration in Singapore.
What are the fees for HSA Singapore medical devices registration?
It depends on the risk classification of the medical device:
- Class A – No product registration fee (only dealer licensing required)
- Class B – SGD 1,060 (Full Evaluation) / SGD 340 (Abridged Evaluation)
- Class C – SGD 3,540 (Full) / SGD 1,180 (Abridged)
- Class D – SGD 6,180 (Full) / SGD 2,060 (Abridged)
Additional fees apply for dealer licenses, import permits, and modification applications. Nyprax Pharma helps clients optimize costs by grouping devices and taking advantage of early submission discounts.
Does Nyprax Pharma assist in post-market compliance?
Yes, we support companies with post-market surveillance, adverse event reporting, and ensuring continued regulatory compliance with HSA guidelines.
Who needs to apply for medical device registration in Singapore?
Manufacturers, importers, and distributors must register medical devices with HSA Singapore before marketing or selling them in the country.
What are the common reasons for delays in HSA registration medical devices?
Delays often occur due to incomplete documentation, insufficient clinical data, misclassification, manufacturer slow response, or HSA queries. Other factors include errors in MEDICS submission, regulatory changes, and high submission volumes. Nyprax Pharma ensures a smooth process by handling documentation, liaising with HSA, and optimizing submissions for faster approval.
What is the validity period of an HSA medical device registration license?
Once approved, the HSA medical device licenses are auto-renewable annually. As long as the annual renewal fees are paid, the license remains valid and is extended year by year.
What happens if a medical device is modified after HSA registration?
Any significant modifications, such as changes in intended use, design, or materials, may require a new registration submission or variation application to HSA. Nyprax Pharma can assess the changes and guide on the appropriate regulatory steps.
What are the penalties for non-compliance with HSA Singapore medical device regulations?
It can result in fines of up to SGD 100,000 and/or imprisonment for up to 3 years under the Health Products Act. Specific violations, such as failure to maintain records or false entries, may carry additional fines and jail terms. Ensuring compliance is crucial to avoid legal action and safeguard public health.
How do I get started with medical device registration in Singapore through Nyprax Pharma?
Getting started is easy! Simply contact us to schedule a free consultation. Our experts will guide you through the entire process smoothly and efficiently.