Tag Archive for: Archive

Korea Intends to Increase Medical Device Registration Fees in 2017

The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications.

India Launches New Medical Device Regulations

Last week the Indian government officially published the Medical Devices Rules, 2017 providing for the comprehensive regulation of all medical and IVD devices in India. The Rules will come into full effect on January 1, 2018. A link to the document is available here on the Asia Actual website (the English version starts on page 143).

India Adds First Medical Device to Price Control System

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.

Know Your Market Price in Japan

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.

India Moves to Online Application Submission System for Medical Device Registration

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).

Increase in Independent License Holder Option in India

More companies are setting up a subsidiary or using an independent license holder in order navigate the highly rationalized Indian market.

Ablation Devices Now Require Registration in India

The India Ministry of Health and Family Welfare added ablation devices to the list of notified medical device that require registration.

New Office Space for Asia Actual India

Asia Actual is excited to announce the dedication of our new office space in the Delhi area.  

Philippines FDA Moves to Streamline Submission Systems for Device Registration and Licensing

This month, the Center for Device Regulation, Radiological Health and Research (CDRRHR) has relocated from the Department of Health in Manila to new facilities within the FDA central compound in Alabang.