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- China Releases New List of Standards for Medical Device Registration July 26, 2024
- Key Takeaways from VietNam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
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India’s New Medical Device Rules Launched on Schedule
/in India, Latest Updates/by Bryan GilburgPhilippines Implements New Customs Clearance Procedure for Radiation Devices
/in Latest Updates, Philippines/by Bryan GilburgRadiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine Food and Drug Administration (FDA)
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.