Philippines: Medical Device Regulatory Updates
CDRRHR shared the following statistics:
Distributors – Wholesalers, Importers, Exporters: 2,470
(Note: 95% of medical devices are imported)
The regulatory information updates, including:
The instrument to implement the AMDD is the Administrative Order No. 2018-002
Date signed: January 26, 2018
With effect from: March 30, 2018
Date of Implementation: October 2019
Transitional Period (for all currently existing in the market): 2 years (October 2021)
Phase 0 - Upon implementation
This AO shall cover initially all registrable products listed in FDA Memorandum Circular No. 2014-005: “Updated List of Medical Devices required to be registered prior to sale, distribution and use” and its amendments; the Notification of all class A medical devices; and the Medical Device Listing.
Notification of Class B, C and D that are non-registrable medical devices based on FDA Memorandum Circular No. 2014-005.
Registration of Class D (Notification of Class D shall cease during this phase).
Registration of Class B and Class C (Notification of classes B and C shall cease during this phase).
FDA Memorandum Circular 2019-005
Selected companies were invited to join the Pilot Study based on the list of priority medical devices that the CDRRHR-LRD would like to study
Application of medical devices included in the Pilot Study can be submitted starting August 19, 2019
Reference: Food and Drug Administration Philippines
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