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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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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 GilburgINDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017
/in India, Latest Updates/by Bryan GilburgNEW OFFICE SPACE FOR ASIA ACTUAL THAILAND
/in Latest Updates, Thailand/by Bryan Gilburg