PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING
The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.
A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.
At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.
With the publishing of the ‘Drug (Prices Control) third amendment Order, 2016’ on December 21, 2016, coronary stents were added the list of devices subject to government price controls. Included in the product definition are bare metal stents, metallic drug eluting stents, and bio-resorbable vascular scaffold/biodegradable drug eluting stents.
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).
Japan should be the second largest national market for your medical device after the United States and maximizing sales performance in Japan should be critical to your overall corporate success. Yet, many manufacturers are frustrated by their results in Japan or struggle to attract the interest of leading distributors. Follow these steps to create a winning market strategy in Japan that will wow investors and leapfrog the competition.
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.
The Drugs Controller General of India (DCGI) announced on May 1, 2016 that the SUGAM online application submission system, in use since November 2015 for pharmaceutical registration, would be extended to medical device and IVD device submissions (e.g., registration and import license applications).
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