Fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products in Malaysia.
Medical devices with substances incorporated when used on their own could
read more...Regulatory News
European Commission release of 8 documents relating to unique device identifiers
Europe, The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs). 4 of them are relating to Basic UDI-DI, which manufacturers can use to connect
read more...European Commission released 8 documents for unique device identifiers (UDIs) for medical devices
The European Commission released 8 documents relating to technical specifications for unique device identifiers (UDIs) for medical devices.
4 of them are relating to Basic UDI-DI, which manufacturers can use to
read more...International Council For Harmonisation Milestones
International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step 4 of the ICH process were adopted. They include:
Q12:
read more...International Medical Device Regulators Forum (IMDRF) released 3 final documents on medical devices
World, International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices. This would replace earlier versions of the documents
read more...Vietnam Ministry Of Health New Feature
Vietnam Ministry Of Health introduced a new feature on their registration website system VNSW on 29th October 2019.
This new feature combines 2 registration both import and product license in 1
read more...US, FY 2020 draft and final guidance list
US, The FY 2020 draft and final guidance list was released by FDA’s Centre for Devices and Radiological Health (CDRH). The new drafts includes coming on device servicing and remanufacturing,
read more...Final documents in regards to clinical evaluations,clinical investigations and clinical evidence for medical devices
World , 3 final documents in regards to clinical evaluations, clinical investigations and clinical evidence for medical devices has been finalized and released by The International Medical Device Regulators Forum
read more...US, FDA exemption of additional class II medical devices
US, FDA proposed the exemption of additional class II medical devices under 5 different product codes from 510(k) requirements. The exemptions followed in accordance to the finalization of a list
read more...