Singapore Medical Device Registration
Singapore market attracts foreign medical device firms looking to grow in Asia due to its increasing demand state of the art healthcare facilities. Qualtech is your ideal partner to for your foray into the Singapore medical device market for an easy and smooth registration process.
Qualtech in Singapore
Expert in Non-Active Device
Our team has assisted several non-active device to access Vietnam market efficiently. Our experience covers contact lens, facial filler, adhesive gel… and other devices.
Market Access Strategy
Qualtech Singapore team offer clients ONE-STOP market access service, covering Regulatory research, Registration, Importation, and Distributor connection.
QT Services
Medical Device Registration
Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with DMEC officers to get your devices registered in the Singapore.
Authorized Representation
As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in the Singapore. This is in compliance with the law for a local establishment to be a license holder.
| Registration with HSA | |
|
Classification
Class A
Low risk device
Product Certificate
Online submission
Class B
Low-Moderate Risk
Product Certificate
Online submission
Class C
High-Moderate Risk
Product Certificate
Online submission
Class D
High Risk
Product Certificate
Online submission
 |
CLASS A | CLASS B | CLASS C | CLASS D |
|---|---|---|---|---|
| Executive Summary | Yes | Yes | Yes | |
| Essential Principles and Methods | Yes | Yes | Yes | |
| Device Description | Yes | Yes | Yes | Yes |
| Summary of Design V&V | Yes | Yes | Yes | Yes |
| Labeling and IFU | Yes | Yes | Yes | Yes |
| Risk Assessment | Yes | Yes | Yes | |
| Physical Manufacturer Information | Yes | Yes | Yes | Yes |
| Summary of clinically testing data | Yes | Yes | Yes |
Note: Kindly see the GN-15-R7.3 Guidance on Medical Device Product Registration for more details.
Workflow
HSA Target Reviewing Turnaround Time
After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the HSA and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration.
| CLASS B | CLASS C | CLASS D | CLASS D*2 | |
|---|---|---|---|---|
| Immediate | Immediate | Immediate*1 | NA | NA |
| Expedited | NA | 120 | 180 | NA |
| Abridge | 100 | 160 | 220 | 220 |
| Full | 160 | 220 | 310 | 310 |
- Note:
- *1 For Class C Medical Mobile Application Only
- *2 Devices incorporating medicinal/therapeutic products
- *3 Timeline is based on the working days
Validity
-
Types of Certificates: Certificate
-
Product Certificate of Class A: Permanent
-
Product Certificate of Class B, C and D: 5 years
Workflow
How Could I Obtain Faster Market Access?
All foreign manufacturer would like to have their product access Singapore market immediately. It’s a good news that HSA offers several faster access routes to shorten the registration timeline.
The product has been circulated in at any one approvals of the following countries: Australia, Canada, European Union countries, Japan, and the United States. HSA allows several evaluation routes with shortened timelines, enabling faster market access.
If a device is not applicable to any of the shortened evaluation routes, HSA has Priority Schemes for full evaluation route. Consult with our regulatory expert to know if your device is eligible for any special route.
For more information, please refer to the Singapore HSA's official website or you may contact us for a free consultation.
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