Singapore Archives | CMS MedTech

COVID-19 Medical Device registration in Singapore

By cmsmedtech January 29, 2022Covid-19, Singapore

COVID-19 Test Kits Authorised for Professional Use With effect from 1 January 2022, only COVID-19 tests that have received full-fledged registration with HSA or have been authorised under the Pandemic…

Singapore: Medical Device Registration in Singapore

By cmsmedtech January 1, 2022Singapore

Medical Device Registration in Singapore: Conclusion to the consultation on Medical Devices Product Classification Guide 1.The Health Sciences Authority (HSA) has concluded the stakeholders’ consultation on the Medical Devices Product…

Medical Device Regulation Singapore

By cmsmedtech September 24, 2021Singapore

Medical Device Regulation SingaporeMedical Device registration is compulsory in Singapore. This means you will need to register your medical device before supplying it in Singapore. Find out how to complete…

HSA requirement in 2024: SAC accreditation for ISO 13485 certificate

By cmsmedtech March 2, 2021Singapore

HSA has expressed that they would be implementing a SAC Accreditation requirement on certification bodies who are issuing ISO 13485 for Singapore manufacturers tentatively in the year 2024.Although this requirement…

How to do Common Submission Dossier Template

By cmsmedtech December 16, 2020Asean, Cambodia, csdt, Indonesia, Myanmar, Philippines, Singapore, Thailand, Vietnam

How to do Common Submission Dossier Template (CSDT) (Video) This CMS MedTech tutorial provides the guidance on how to do ASEAN Medical Device Common Submission Dossier Template (CSDT) Visit cmsmedtech.com…

When to implement UDI?

By cmsmedtech October 22, 2020CE, Singapore, udi

When to implement UDI? For CE Eventually all Medical Device entering EU markets under than custom made and performance studies/ investigational devices. Most of the time the question is when…

COVID-19 Medical Device registration in Singapore

Singapore: Medical Device Registration in Singapore

Medical Device Regulation Singapore

HSA requirement in 2024: SAC accreditation for ISO 13485 certificate

How to do Common Submission Dossier Template

When to implement UDI?

EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS

Medical Device Registration in Thailand

Medical Device Registration Vietnam (updated 2023)

Medical Device Registration in UK

Medical Device Registration in New Zealand