To comply with the ASEAN Medical Device Directive (AMDD), the Philippines issued new "Guidelines Governing the Issuance of Authorization for Medical Devices based on the ASEAN Harmonized Technical Requirements". The document governs the notification or registration of medical devices with the Food and Drug Administration (FDA) prior to importation, exportation, marketing, manufacturing, and distribution on the territory of the Philippines (known as Administrative Order 2018-0002 dated January 26, 2018).
The FDA of the Philippines intended to implement the first two phases of the new medical device regulatory system on April 11, 2019. However, the implementation date has been delayed.
Extra time is needed for the CDRRHR to finalized guidelines for classification, grouping, etc.
No formal guidance on the new target implementation date has been announced. Meanwhile, the CDRRHR will continue to accept and process Certificate of Product Registration (CPR) and Certificate of Exemption (COE) applications under the current Rules.
From the date of implementation of AO 2018-0002, Class A, B, C, and D medical devices will require a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market of the Philippines. Manufacturers. Their local authorized agents should also have a 12-month grace period to comply before losing the access to the market.
The official processing time will remain 180 working days.
Once implementation is made official, medical device companies can not import, export, manufacture, distribute or market their medical devices in the Philippines if these products are not notified to or registered with the FDA, depending on the risk classification of the subject medical device. Previously, only medical devices specifically mentioned in the FDA list of registrable medical devices, required registration. Medical device companies must now determine the risk classification of the medical devices that they distribute within the Philippines, and make sure their products comply with the applicable requirements for notification or registration.
The official document is available here.
The information has been prepared by the GMA Consult Group team.
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