Tag Archive for: FDA

Philippines Incentivizes Local Medical Device Manufacturing

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July 31st, 2024: Philippines established its first inaugural Pharma-Med Development Hub, which will contribute to local medical development.

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Philippines Issues Guidance on Medical Device Labeling

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On April 5th, the CDRRHR provided guidance for CMDR medical device labeling in the Philippines related to previously CMDN labeled stock.

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Philippines FDA Extends CMDN Deadline to 2024

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The Philippines Center for Device Regulation, Radiation Health and Research (CDRRHR) has announced that Certificate of Medical Device Notification (CMDN) applications for non-Notified Class B, C and D Medical Devices will be extended to September 30, 2024.

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Philippines FDA Announces New Fee Schedule for Medical Devices

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On November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.

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Thailand FDA to Improve Medical Device Advertising Review Times

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In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.

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Philippines Proposes New Fees for Medical Device Registration

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The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. 

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