Medical Device Regulatory Updates

Medical Device Registration in Malaysia

By cmsmedtech January 29, 2022Malaysia

Medical Device Registration in Malaysia ANNOUNCEMENT TO PUBLIC: INTRODUCING MEDC@ST 2.0 PLUS IMPROVEMENTS SYSTEM MedC@st 2.0 Plus System is back with advanced features that facilitate the applicants to experience better.The…

Covid-19 medical device registration in Singapore

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 Registration in Vietnam

By cmsmedtech November 22, 2021Vietnam

Key highlight for New Decree 98/2021 Registration:Fast track registration: only request 1 CFS from reference countriesAdd S. Korea and China to reference countriesClass B medical devices will be registered as…

Medical Device Registration in EAEU

By cmsmedtech October 14, 2021Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia

Medical Device Registration in EAEU (RUSSIA, BELARUS, ARMENIA, KAZAKHSTANAND KYRGYZSTAN) THE TRANSITION PERIOD ON THE MEDICAL PRODUCTS MARKET THE EAEU INCLUDES RUSSIA, BELARUS, ARMENIA, KAZAKHSTANAND KYRGYZSTANIN 2016 THE COUNCIL OF…

Medical Device Registration in UK

By cmsmedtech October 2, 2021UK

Medical Device Registration in UK Steps to Medical Device Registration in UK Please see the steps below for Medical Device Registration in UK (excluding Northern Ireland). We could also term…

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…

Medical Device Registration in India

By cmsmedtech September 22, 2021India

Medical Device Registration in India Voluntary Registration for Non-Notified Medical Devices The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. There are two major pathways for the…

Australia: Medical Device Registration in Australia

By cmsmedtech July 1, 2021Australia

Medical Device Registration in Australia Regulation of Personal Protective Equipment and COVID-19 In response to COVID-19, there is increasing interest in understanding the regulation of Personal Protective Equipment (PPE) that…

Medical Device Registration in Mexico

By cmsmedtech June 1, 2021Mexico

Medical Device Registration in Mexico Medical Device Regulation change effective 1st June 2021 As part of our goal to keep you informed about the latest news regarding theregulatory process for…

Philippines-Food-and-Drug-Administration

Medical Device Registration in Philippines

By cmsmedtech May 6, 2021Philippines

Medical Device Registration in Philippines May 2021: Class A list List-of-Class-A-Medical-DevicesDownload Jan 2021: All remaining class B C D medical devices update As of Jan 2021, all medical devices (not…

Medical Device Registration in Malaysia

Singapore: Medical Device Registration in Singapore

Medical Device Registration in Vietnam

Medical Device Registration in EAEU

Medical Device Registration in UK

Medical Device Regulation Singapore

Medical Device Registration in India

Australia: Medical Device Registration in Australia

Medical Device Registration in Mexico

Medical Device Registration in Philippines

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