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.
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.
Qualtech Singapore team offer clients ONE-STOP market access service, covering Regulatory research, Registration, Importation, and Distributor connection.
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.
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|
|CLASS A||CLASS B||CLASS C||CLASS D|
|Essential Principles and Methods||Yes||Yes||Yes|
|Summary of Design V&V||Yes||Yes||Yes||Yes|
|Labeling and IFU||Yes||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.
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|
Types of Certificates: Certificate
Product Certificate of Class A: Permanent
Product Certificate of Class B, C and D: 5 years
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.
| ★ 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