Singapore HSA

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

The Health Sciences Authority (HSA) was a statutory board of the Singapore Ministry of Health. The Health Products Regulation Group ensures that medical devices are wisely regulated and meet safety, quality, and efficacy standards. The HSA’s vision is to be the leading innovative authority protecting and advancing national health and safety.

Foreign manufacturers (outside Singapore) must appoint local Representative called a Registrant to manage device registration and to authorize an importer and distributor to import and supply devices post approval. Only One Registrant per Device. However, a foreign manufacturer with multiple devices can appoint more than one Registrant.

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

 

 

TECHNICAL REQUIREMENTS

Qualtech 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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Official Website
 
 

HSA Website Homepage
Class A Product Database
Class B, C, D Product Database
Regulatory Announcement Board

Adverse Event Monitoring System

Recommendation
 
 
★ SINGAPORE: Regulation Amendments for Medical Device Effective June 2018
SINGAPORE: HSA to implement new fees for Medical Devices on April 2019
SINGAPORE: HSA Releases Updated Guidance on Medical Device Field Safety Correction Action