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- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
- Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit November 2, 2023
- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
- India Grants Import License Grace Period for Class C/D Devices October 16, 2023
- Indonesia to Require Post-Market In-Country Testing of Medical Devices October 11, 2023
- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023
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Russia Streamlines Medical and IVD Device Regulations
/in Latest Updates, Russia/by Bryan GilburgOn the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.
India to Regulate More Medical Devices
/in India, Latest Updates/by Bryan GilburgAt the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected:
Philippines Announces New Medical Device Regulations
/in Latest Updates, Philippines/by Bryan GilburgIndonesia the Next to Takes Steps Toward ASEAN MDD Harmonization
/in Indonesia, Latest Updates/by Bryan GilburgAsia Actual Expands into Russia
/in Latest Updates, Russia/by Bryan GilburgIndia to Require Ultrasound and Imaging Equipment to be Registered with the CDSCO
/in India, Latest Updates/by Bryan GilburgNew Regulations in India Raise the Bar for Many IVD Devices
/in India, Latest Updates/by Bryan GilburgThe new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.
Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices
/in Indonesia, Latest Updates/by Bryan Gilburg