Search Our News
- An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases May 30, 2023
- Vietnam Diagnostic Imaging Center Hosts AI Software Conference May 11, 2023
- India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline April 18, 2023
- China CMDE Supplementary Documents Submission Deadline Extended April 11, 2023
- UDI Labelling Mandatory for Certain Taiwan Medical Devices April 6, 2023
- Philippines FDA Extends CMDN Deadline to 2024 March 31, 2023
- India’s CDSCO Releases Guidance for Renewing Medical Device Import Licenses March 20, 2023
- 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
Blogs by Country
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
116 Changi Road, #04-05
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.
Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices/in Latest Updates, Philippines/by Charmaine Roson
On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).