Tag Archive for: Archive

Ablation Devices Now Require Registration in India

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

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New Office Space for Asia Actual India

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

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

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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.

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The Philippines Appoints New FDA Director General

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President Rodrigo Duterte appointed Charade Galang-Puno as the new Director General of the Philippines Food and Drug Administration. Dr. Galang-Puno is one of 42 appointees sworn in on Monday, August 15 at the Malacañang Palace in Manila.

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The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration

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The Philippines FDA Publishes New Guidance on Medical Device Recalls

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The Philippines Food and Drug Administration (FDA) has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.

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Korea Intends to Increase Medical Device Registration Fees in 2017

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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.

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India Launches New Medical Device Regulations

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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).

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India Adds First Medical Device to Price Control System

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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.

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