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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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Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019
/in Latest Updates, South Korea/by Bryan GilburgThe Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.
India Government Releases New List of Regulated Medical Devices
/in India, Latest Updates/by Bryan GilburgINDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES
/in India, Latest Updates/by Bryan GilburgYesterday, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price controls for knee prostheses resulting with an average reduction of 65% from prevailing market prices. The announcement was published on August 16, 2017, with immediate effect (full document available on the India page of Asia Actual’s website).
Indonesia Ministry Opened e-Catalogue Registration for Certain Medical Devices
/in Indonesia, Latest Updates/by Bryan GilburgTHAI FDA PLANS TO CHARGE FEES FOR EXPERT REVIEW IN MEDICAL DEVICE REGISTRATIONS PROCESS
/in Latest Updates, Thailand/by Bryan GilburgINDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES
/in India, Latest Updates/by Bryan GilburgExactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.
PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES
/in Latest Updates, Philippines/by Bryan GilburgWith FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines Food and Drug Administration (FDA) announced intentions to gradually switch to power-free gloves. A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.
MEDICAL DEVICE REGISTRATION FEES INCREASE IN KOREA
/in Latest Updates, South Korea/by Bryan Gilburg