IVD Medical Device Registration in Singapore
Singapore is a key market for in-vitro diagnostic (IVD) device manufacturers looking to expand their presence in Southeast Asia. The Health Sciences Authority (HSA) is now recognised as a World Health Organization stringent regulatory authority (SRA) and regulates the registration and approval of IVD devices in Singapore. HSA’s approval can serve as a springboard for faster market access in other Southeast Asian countries.
Our team of experienced regulatory affairs specialists offer comprehensive support, from initial classification and submission to post-market compliance and help you navigate HSA processes better.
Why Register Your IVD Medical Device in Singapore?
Access to a Growing Market
Access to a Growing Market
Singapore is renowned for its advanced healthcare system and cutting-edge medical technologies. Registering your IVD device in Singapore means gaining access to a market that values innovation and has the purchasing power to invest in high-quality diagnostic tools.
Stringent Regulatory Standards
Stringent Regulatory Standards
Singapore’s regulatory standards are among the highest in the world. The HSA adheres to stringent regulations that align closely with international best practices. This ensures that your product meets global quality and safety standards, which can be a significant selling point when marketing your device locally and internationally.
Potential for Faster Market Entry in Southeast Asia
Potential for Faster Market Entry in Southeast Asia
Singapore’s strategic location and its status as a leading business hub in Southeast Asia make it an excellent starting point for regional market expansion. Successful registration in Singapore can expedite the approval process in other Southeast Asian countries.
Well-Established Healthcare Infrastructure
Well-Established Healthcare Infrastructure
Singapore’s healthcare infrastructure continually evolves to incorporate the latest advancements in medical technology. This environment not only supports the adoption of innovative IVD devices but also provides a seamless platform for clinical validation and real-world testing.
Our IVD Medical Device Registration Services
Regulatory Strategy
Tailored regulatory strategy based on your medical device's classification and target market.
Dossier Preparation
Compiling and reviewing all necessary documentation for HSA requirements.
Submission Management
Handling the entire submission process, including communications with HSA.
Post-Market Compliance
Assist in adverse event reporting, change notifications and more.
HSA Registration Process Overview
Step 1: Identify
To identify whether it is a Medical Device under the definition of an in vitro diagnostic (IVD) product in the Medical Device Regulations
Step 2: Classification
IVD devices are classified into four risk classes (A, B, C, and D) based on their intended uses and potential risks.
Step 3: Submission
The registration dossier is submitted electronically via the Medical Device Information and Communication System (MEDICS).
Step 4: Evaluation
HSA reviews the submission and may request additional information or clarification.
Step 5: Approval
Upon successful evaluation, product approval accorded by HSA is indefinite.
Step 1: Identify
To identify whether it is a Medical Device under the definition of an in vitro diagnostic (IVD) product in the Medical Device Regulations
Step 2: Classification
IVD devices are classified into four risk classes (A, B, C, and D) based on their intended uses and potential risks.
Step 3: Submission
The registration dossier is submitted electronically via the Medical Device Information and Communication System (MEDICS).
Step 4: Evaluation
HSA reviews the submission and may request additional information or clarification.
Step 5: Approval
Upon successful evaluation, product approval accorded by HSA is indefinite.
Why Register Your IVD Medical Device in Singapore?
| Risk Class | Application Fees | Evaluation Fees | |||||
|---|---|---|---|---|---|---|---|
| Immediate Class B Registration | Expedited | Abridged | Full | Priority Review Scheme | |||
| Full (Route 1) | Full (Route 2) | ||||||
| Class B | S$560 | S$1,000 | S$2,010 | S$3,900 | S$4,420 | S$5,660 | |
| Class C | S$560 | S$3,340 | S$3,340 | S$3,900 | S$6,250 | S$7,000 | S$9,000 |
| Class D | S$560 | S$5,930 | S$6,250 | S$12,000 | S$13,600 | S$17,500 | |
| Class D, devices incorporating medicinal / therapeutic products | S$560 | S$10,600 | S$75,600 | ||||
| Risk Class | Evaluation Fees | ||||
|---|---|---|---|---|---|
| Immediate | Expedited | Abridged | Full | Full (Priority Review Scheme) | |
| Class B | Immediate Registration upon Submission | 100 | 160 | 104 | |
| Class C | Immediate registration upon submission (for Class C standalone medical mobile application only) | 120 | 160 | 220 | 143 |
| Class D | 180 | 220 | 310 | 202 | |
| Class D, devices incorporating registrable medicinal /therapeutic products | 220 | 310 | |||
| Class | Fee | Timeline |
|---|---|---|
| Class B | S$39 | Immediate Renewal upon retention fee payment. |
| Class C | S$67 | |
| Class D | S$134 | |
| Class D with registrable drug | S$134 |
Why Choose Andaman Medical?
Our expert guidance through the region's evolving regulatory landscape ensures your product remains compliant, allowing you to bring your products to market efficiently and effectively.
Experienced In-house Team
across 7 Southeast Asian Countries
Full Control with Seamless
Distributor Switching
Singular Point of Contact
for Registration
QMS Compliance
ISO 13485 Certified
Overcome Language Barrier
With Multilingual Local Team
One-Stop Access
into Southeast Asia
