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- 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
- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022
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Thailand to Implement New Medical Device Classification System
/in Latest Updates, Thailand/by AsiaActualAdminThe Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.
Ablation Devices Now Require Registration in India
/in India, Latest Updates/by AsiaActualAdminThe India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.
Increase in Independent License Holder Option in India
/in India, Latest Updates/by AsiaActualAdminMore companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.
India Moves to Online Application Submission System for Medical Device Registration
/in India, Latest Updates/by AsiaActualAdminThe Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).
Know Your Market Price in Japan
/in Japan, Latest Updates/by AsiaActualAdminJapan should be the second largest national market for your medical device after the United States and maximizing sales performance in Japan should be critical to your overall corporate success. Yet, many manufacturers are frustrated by their results in Japan or struggle to attract the interest of leading distributors. Follow these steps to create a winning market strategy in Japan that will wow investors and leapfrog the competition.
MEDICAL DEVICE SALES IN ASIA
/in China, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Thailand/by Bryan Gilburg