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- 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
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KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS
/in Latest Updates, South Korea/by Bryan GilburgAny company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to several new requirements. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
India to Regulate Surgical Drapes and Gowns
/in India, Latest Updates/by Bryan GilburgSurgical drapes and gowns have been added to the Indian list of notified medical devices. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.
PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS
/in Latest Updates, Philippines/by Bryan GilburgThe Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed. Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.
INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION
/in India, Latest Updates/by Bryan GilburgThis Notification announcement represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.
THAILAND TO REGULATE HAND SANITIZER AS A MEDICAL DEVICE
/in Latest Updates, Thailand/by Bryan GilburgPHILIPPINES NEW MEDICAL DEVICE REGULATIONS TO LAUNCH IN APRIL
/in Latest Updates, Philippines/by Glend LlantadaHONG KONG OPENS THE VOLUNTARY REGISTRATION SYSTEM TO CLASS B & C IVD DEVICES
/in Hong Kong, Latest Updates/by Bryan GilburgINDIA REQUIRES MORE NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017
/in India, Latest Updates/by Bryan Gilburg