Search Our News
Latest Headlines
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
Blogs by Country
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
Asia Headquarters
116 Changi Road, #04-05
Singapore 419718
+65 8800-3197
India Requires Mandatory Local BIS Certifications for Certain Medical Devices
/in India, Latest Updates/by Gunjan VermaThis 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 SuwannabotGet 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 RosonThe 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 PranotoOn 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 SuwannabotOn 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 RosonOn 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).
Indonesia e-Catalogue Implementation Review, December 2022
/in Indonesia, Latest Updates/by Ilham HidayattulahOn April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
The Vietnamese MOH Issues Draft Decree to Address Delays
/in Latest Updates, Vietnam/by David VoOn November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.