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- Philippines FDA Medical Device Labeling CMDN to CMDR Labeling Guidance May 7, 2024
- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- 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
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The Philippines FDA Publishes New Guidance on Medical Device Recalls
/in Latest Updates, Philippines/by AsiaActualAdminThe Philippines Food and Drug Administration (FDA) has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.
The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration
/in Latest Updates, Philippines/by AsiaActualAdminThe Philippines Appoints New FDA Director General
/in Latest Updates, Philippines/by AsiaActualAdminPresident Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.
Philippines FDA Moves to Streamline Submission Systems for Device Registration and Licensing
/in Latest Updates, Philippines/by AsiaActualAdminThis month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.
New Office Space for Asia Actual India
/in India, Latest Updates/by AsiaActualAdminAsia Actual is excited to announce the dedication of our new office space in the Delhi area.
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).