Philippines: Medical Device Regulatory Updates

August 29, 2019

 

CDRRHR shared the following statistics:

 

Manufacturers/Repacker: 74

Trader: 51

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.

 

Phase 1

Notification of Class B, C and D that are non-registrable medical devices based on FDA Memorandum Circular No. 2014-005.

 

Phase 2

Registration of Class D (Notification of Class D shall cease during this phase).

 

Phase 3

Registration of Class B and Class C (Notification of classes B and C shall cease during this phase).

 

Pilot Study

  • 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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