Singapore Medical Device Registration & Regulatory Services
MediPass helps you navigate HSA requirements with clarity — from Product Classification, Grouping, and Registration Pathway Selection to Local Regulatory Coordination and Post-Market Compliance.
Class A–D, Single, Family, System, Group, IVD Test Kit, IVD Cluster
Pathway Determination & CSDT Dossier Preparation
Registration Holder & Local Coordination
Complaint Handling, Adverse Event Reporting, FSCA & Recall
Singapore & Southeast Asia
Strategy
One Regional Partner
for Foreign Manufacturers
The ASEAN Medical Device Directive (AMDD) supports regulatory harmonisation across Southeast Asia, but it does not create a single approval valid across all ASEAN markets. In practice, each country still maintains its own regulatory authority, local requirements, and registration pathway.
For foreign manufacturers, MediPass supports Singapore market entry under HSA requirements while serving as the One Regional Partner for broader ASEAN planning. We help align country-specific registration strategy, local representation, and post-market coordination across multiple ASEAN markets.
Singapore Market Snapshot
Key demographic, economic, and medical device registration indicators relevant to Singapore market entry.
Country Overview
Selected macro indicators based on 2025 data
Medical Device
Selected SMDR indicators (last update on 16th April 2026, excluding Class A)
Medical Devices in Singapore
Regulated by the Health Sciences Authority (HSA) under the Health Products Act and Health Products (Medical Devices) Regulations 2010. Market entry typically involves risk classification, grouping assessment, identifying the evaluation route, dossier preparation and registration through SHARE.
Registration Process
Determine
Device Status
Classify
A / B / C / D
Define
Grouping
Prepare
CSDT Dossier
Submit
SHARE Portal
Registration Pathways
In Singapore, Class A medical devices are exempt from registration; however, registrants must submit a notification in SHARE. Class B, C, and D medical devices require product registration, and the applicable evaluation route depends on the device’s risk classification, with expedited routes (immediate, abridged, and expedited) available for eligible devices with prior approvals from HSA’s overseas reference regulatory agencies (Australia TGA, Canada HC, Japan MHLW, U.S. FDA, E.U. NB, and Malaysia MDA).
Class A medical devices are exempt from product registration in Singapore. However, manufacturers or importers must submit a product notification application in SHARE before supply.
Immediate Route
For eligible devices with at least one (1) qualifying reference agency approval, with 3 years of safe marketing history. OR at least two (2) qualifying reference agency approvals with no unresolved global safety concern should exist at the point of submission. Such eligible applications are listed in the SMDR immediately upon successful submission in SHARE.
Abridged Route
For eligible devices with at least one (1) qualifying reference agency approval, the abridged route may apply, subject to review of the relevant CSDT documents and supporting evidence before approval.
Full Route
The Full Route applies to devices without prior approval from any of HSA’s overseas reference regulatory agencies. It requires the most comprehensive review and submission package, including the full set of applicable CSDT documentation and supporting technical evidence. Where eligible, applicants may opt for the Priority Review Scheme for a shorter review timeline.
Immediate Route
For eligible standalone medical mobile applications with at least one (1) qualifying reference agency approval, with no unresolved global safety concern at the point of submission. Such eligible applications are listed in the SMDR immediately upon successful submission in SHARE.
Expedited Route
For eligible devices with at least one (1) qualifying reference agency approval, with 3 years of safe marketing history. OR Devices with at least two (2) qualifying reference agency approvals may also qualify. Certain non-bioactive implant devices are excluded from this route.
Abridged Route
For eligible devices with at least one (1) qualifying reference agency approval, the abridged route may apply.
Full Route
The Full Route applies to devices without prior approval from any of HSA’s overseas reference regulatory agencies. It requires the most comprehensive review and submission package, including the full set of applicable CSDT documentation and supporting technical evidence. Where eligible, applicants may opt for the Priority Review Scheme for a shorter review timeline.
Expedited Route
For eligible devices with at least two (2) qualifying reference agency approvals. Certain devices are excluded from this route, including active implantable devices, implantable devices in direct contact with the central circulatory or central nervous system, hip, knee and shoulder joint replacement devices, devices with a registrable drug, and IVD assays intended for HIV testing or blood/tissue donor compatibility testing.
Abridged Route
For eligible devices with at least one (1) qualifying reference agency approval, the abridged route may apply.
Full Route
The Full Route applies to devices without prior approval from any of HSA’s overseas reference regulatory agencies. It requires the most comprehensive review and submission package, including the full set of applicable CSDT documentation and supporting technical evidence. Where eligible, applicants may opt for the Priority Review Scheme for a shorter review timeline.
Classification at a Glance
In Singapore, both General Medical Devices and In Vitro Diagnostics (IVD) are classified into four risk-based classes, from Class A to Class D. The higher the risk class, the greater the level of regulatory control required for market access.
General Medical Devices
Devices intended for use in or on the human body for medical purposes, whose primary action is not achieved by pharmacological, immunological, or metabolic means.
Tongue depressor, Examination gloves or lights, Adhesive bandages (plasters), Walking aids…
Fixed dental prosthesis, Anesthetic breathing circuits, Endoscopy System, Sleep therapy, Hearing aids…
Ureteral Stent, Lung ventilator, Orthopedic implants, Contact lens disinfecting/cleaning, Defibrillator…
Bone Grafts, Blood bags, Sodium hyaluronate syringes, Central venous or Neurological catheters…
In Vitro Diagnostics (IVD)
Devices intended for the in vitro examination of specimens derived from the human body to provide medical or diagnostic information.
Culture media, Specimen receptacles (urine cups), Microscope, Freezer, Centrifuge, Collection Swab…
Pregnancy, Fertility, RNA extraction, Ovulation, Blood tube, Drugs of abuse, Hepatitis A, H.Pylori Tests …
Blood glucose, PSA, Syphilis, Human papillomavirus (HPV), Dengue, Respiratory viruses Tests (Influenza)…
HIV blood donor screening/diagnostic tests, ABO blood typing, Hepatitis B, Hepatitis C Tests…
Grouping Strategy for Efficient Registration Planning
In Singapore, Grouping is not only a filing format. An early grouping strategy helps reduce duplicate registrations and simplify lifecycle management.
· One proprietary name · One manufacturer · One common intended purpose
Single
A distinct medical device from one product owner identified by a proprietary or brand name with a specific intended purpose. It is sold as a distinct packaged entity and may also be offered in different pack sizes. Devices that do not meet another grouping category are registered as a SINGLE.
Family
A collection of medical devices from the same product owner and of the same risk classification, sharing a common intended purpose, common design and manufacturing process, and only permissible variants. Different proprietary names may be submitted in one FAMILY application, but they may be listed separately on the SMDR upon approval.
System
A number of compatible medical devices and/or accessories intended to be used together to achieve one common intended purpose, and sold under a single SYSTEM name or clearly identified in the labelling, IFU, brochures, or catalogues for use with that SYSTEM.
Group
A collection of two or more medical devices labelled and supplied in a single packaged unit by the product owner, under one proprietary GROUP name and for one common intended purpose. Different quantities or permutations may be supplied within the registered closed list while maintaining the same GROUP name and intended purpose.
IVD Test Kit
A grouping of compatible reagents and/or articles from the same product owner intended to be used together to complete one specific intended purpose under a single test kit name. Analysers are not included in the IVD TEST KIT grouping.
IVD Cluster
A specific IVD grouping route for Class A only or Class B only reagents or articles from the same product owner, with the same risk classification, common test methodology, and within the same closed-list IVD CLUSTER category. Products may be grouped in one submission, but individual listings on the SMDR may still differ upon approval.
Get Your Free Singapore Market Assessment
Submit your product details and let MediPass recommend the most efficient filing strategy — saving you time, reducing costs, and providing actionable guidance for smooth market entry in Singapore, and across Southeast Asia.
Select the appropriate risk classification for your medical device to proceed correctly.
Understand the criteria for Immediate, Expedited, Abridged, Full, Priority Review Route 1 and Priority Review Route 2.
Develop a tailored submission plan, considering optimal routes based on product type and risk class.
Leverage professional expertise for in-depth guidance through complex HSA requirements with confidence.
Need help with classification, grouping strategy, or registration pathway?
*Accepted file types include IFUs, Brochures, or existing Approval documents. Please attach to help us assess your product.
Initial assessment within 1 business day
Singapore HSA Fee Overview (Effective January 1, 2026) |
|||||
|---|---|---|---|---|---|
| Device Classification | Application fees | Evaluation Routes | |||
| Immediate | Expedited | Abridged | Full / Priority R1 / Priority R2 | ||
| Class A | Exempt from Registration | ||||
| Class B | For any Class B, C or D device registration SGD 560 | SGD 1,000 | N/A | SGD 2,010 | SGD 3,900 / $4,420 / $5,600 |
| Class C | SGD 3,340 | SGD 3,900 | SGD 6,250 / $7,000 / $9,000 | ||
| Class D | N/A | SGD 5,930 | SGD 6,250 | SGD 12,000 / $13,600 / $17,500 | |
| Class D with registrable Drug | N/A | N/A | SGD 10,600 | SGD 75,600 | |