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New Regulations in India Raise the Bar for Many IVD Devices
The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.
The Philippines FDA Streamlines Amendment Submission Process
On December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.
Philippines Implements New Customs Clearance Procedure for Radiation Devices
Radiation-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
The 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 APPLIES PRICE CONTROLS TO KNEE PROSTHESES
Yesterday, 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).