The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized Technical Requirements, based on the Common Submission Dossier Template (CSDT). Medical devices will be classified into four categories - Class A, B, C and D, with Class A having the lowest risk to Class D with the highest risk. The effective date of the AO is on March 30, 2018 whereby the date of implementation is expected to be one year after, on March 30, 2019.
This documentary does not apply to in-vitro diagnostic and refurbished medical devices, for which a separate Administrative Order shall be issued. The in-vitro diagnostic draft has been shared for industry feedback.
The Philippines FDA has opened a discussion and are conducting a pilot study during this one year transition period on the classification of Medical devices.
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