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Philippines: Revision in Application Process for CMDR/CMDN, Initial & Renewal (10 January 2024)

Updated: Apr 16

Effectively starting from 10 January 2024, all initial applications for Certificate of Medical Device Registration (CMDR) and renewal applications for Certificate of Medical Device Notification (CMDN)/CMDR shall be entitled to “one-time compliance” for submission of the deficiencies requested during the application review. Disapproval applications may occur if the requested documents are not submitted within the provided timeframe.


The FDA of the Philippines allows for the re-application or full compliance to be made for disapproved applications within the specific period, upon the date of the disapproval.


Initial Application: Sixty (60) days

Renewal Application: Thirty (30) days


Applicants shall include a copy of the Notice of Deficiency (NOD) and documents requested in the NOD. Besides, a corresponding fee will also be charged and a new Document Tracking Number (DTN) will be assigned for the re-application procedure. Applicants are advised to use the old application DTN in the re-application email to the FDA for new DTN issuance. The new DTN will be used for the re-application fee payment.

 


Contact us at info@arqon.com for more information.

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