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?

Registering your IVD device in Singapore offers a strategic advantage for companies seeking to establish a strong foothold in the Asia-Pacific region.

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

The HSA registration process involves a series of well-defined steps designed to assess and validate the safety of IVD devices.

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?

Fees
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
Timeline
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
For Medical Device and IVD renewals
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 as Your IVD Consultant in Singapore?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for IVD registration and market access in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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