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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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China Continues to Implement UDI of Medical Devices with Third Batch Release/in China, Latest Updates/by Todd Daigneault
The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.
USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices/in Latest Updates, Philippines/by Charmaine Roson
Learn about the recent Virtual Regional Workshop on Good Regulatory Practices and Medical Device Regulation hosted by USAID, ANSI, and AdvaMed. Attendees gained valuable knowledge on navigating the complex world of medical device regulation, including discussions on specific GRPS, WHO global model regulatory framework updates, and country experiences with reliance models. Read on to discover the benefits of recognizing foreign conformity assessment results, transparency, predictability, inclusion, consistency, and accountability.
Vietnam Extends Validity of Medical Device Import Licenses/in Latest Updates, Vietnam/by David Vo
On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
India Requires Mandatory Local BIS Certifications for Certain Medical Devices/in India, Latest Updates/by Gunjan Verma
This blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.
Thai FDA Issues Guidance on Specialist Review Selection Criteria/in Latest Updates, Thailand/by Noi Suwannabot
Get the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.
Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies/in Latest Updates, Philippines/by Charmaine Roson
The Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”
Hong Kong Refines Medical Device Post-Market Surveillance Report Form/in Hong Kong, Latest Updates/by Albert Pranoto
On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.
Thailand FDA Provides Guidance on Classification of Physical Therapy Devices/in Latest Updates, Thailand/by Noi Suwannabot
On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.