Dear eFOI user,
Thank you for your request dated Nov. 7, 2024, made under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.
You have requested the MEDICAL DEVICE APPROVAL CRITERIA
Please find below the relevant issuances regarding the licensing of medical device establishments and the registration of medical devices:
I. License to Operate
1. Administrative Order 2020-017
2. FDA Circular 2021-014
3. FDA Circular 2021-021
4. FDA Circular 2022-007
II. Certificate of Product Registration
1. Administrative Order 2018-002
2. FDA Circular 2020-001
3. FDA Circular 2020-001-A
4. FDA Circular 2020-026
5. FDA Circular 2021-002
Please be informed that these documents are available for download via Google Chrome by entering the issuance name in the search bar, or you may access them directly on our website at www.fda.gov.ph. Kindly accomplish the FOI Request Feedback form at the link: https://bit.ly/DOHFOIFeedbackForm
Your right to request a review
If you are dissatisfied with our response to your FOl request, you have the option to request an internal review. To initiate this process, kindly submit your written appeal for review addressed to the Central Appeals and Review Committee (CARC) at [email protected].
Please provide a detailed explanation of your dissatisfaction with our response within 15 calendar days from the date of receiving this response. We will conduct the review and communicate the outcome within 30 calendar days from the receipt of your review request.
Should you remain unsatisfied with the review outcome, you retain the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).
Thank you.
Respectfully,
FOI Officer
Department of Health