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- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
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Indonesia Medical Device e-Catalogue Enrollment: 2018 Debrief/in Indonesia, Latest Updates/by Bryan Gilburg
India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers/in India, Latest Updates/by Bryan Gilburg
At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.
Indonesia Tightens Enforcement of Medical Device Licensing/in Indonesia, Latest Updates/by Bryan Gilburg
With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.
Philippines Proposes New Fees for Medical Device Registration/in Latest Updates, Philippines/by Glend Llantada
The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.
Russia Streamlines Medical and IVD Device Regulations/in Latest Updates, Russia/by Bryan Gilburg
On 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 Gilburg
At 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 Gilburg
Indonesia the Next to Takes Steps Toward ASEAN MDD Harmonization/in Indonesia, Latest Updates/by Bryan Gilburg