The Philippines Food and Drug Administration (FDA) issued an advisory No. 2024-0009, dated 10 January 2024, regarding Revision in the Process of Application for Certificate of Medical Device Registration (CMDR) / Certificate of Medical Device Notification (CMDN), Initial and Renewal.
There are a few key points highlighted in the FDA Advisory with regards to the processing of CMDR initial and CMDR/CMDN renewal application, as follows:
- The applicant company will be given a “one-time compliance” to reply and submit the noted deficiencies within the given period. Failure to submit on time will be considered disapproved.
- If the submitted compliance is denied, the applicant needs to re-apply and full compliance is required within sixty (60) calendar days for the initial application, and thirty (30) calendar days for the renewal application from the date of disapproval.
- The submitted re-application will have a new document tracking number (DTN) and will need to pay a corresponding fee of PHP 1,010.00, inclusive of the legal Research Fee (LRF).
- The re-application submission of documents will only include the copy of NOD and the completion of all noted deficiencies.
- The re-application documents shall be sent to fdac@fda.gov.ph with subject: RE-APPLICATION DTNXXXXXXXXXXXX (old Application DTN), for the issuance new DTN. The new DTN will be used for paying the said fee.
This FDA Advisory will be effective 15 days after its publication in the official gazette or any newspaper of general circulation within the 1st quarter of 2024.
Further information on the FDA Advisory can be found here.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.