FDA Circular No.2021-021

Notifying member
Philippines
Title
FDA Circular No.2021-021
First published
07/10/2021
First EIF
05/06/2020
Latest published
02/02/2022
In force to
Latest notification
G/LIC/N/3/PHL/16
Product categories
List of products subject to licensing

9033Parts and accessories for machines, appliances, instruments or other apparatus in chapter 90, specified neither in this chapter nor elsewhere

Nature of licensing

Non-automatic

Administrative purpose/measure being implemented
  • Other
Decription of purpose/measure being implemented

To specify establishment classified as retailers of medical devices; to clarify the licensing of drug outlets which are also retailers of medical devices; to provide specific requirements for and responsibilities of qualified persons and for post licensing inspection of retailers of medical devices.

Administrative body(ies) for submission of applications
Food and Drug Administration
1781 Civic Dr, Alabang, Muntinlupa, 1781 Metro Manila
https://www.fda.gov.ph
+632 8 857-1900

info@fda.gov.ph

Contact point for information on eligibility

Same as the "Administrative bodies"

Expected duration of licensing procedure
Ongoing
Found by secretariat
No
Related document symbols
  • G/LIC/N/2/PHL/191
Source
Notes
  • G/LIC/N/2/PHL/191


    FDA Circular No.2021-021 – Guidelines on the Licensing of Retailers of Medical Devices in the Philippines


    Retailers of medical devices


    9033.00.00 - Parts and accessories (not specified or included elsewhere in Chapter 90) for machines, appliances, instruments or apparatus of Chapter 90


    This FDA Circular was issued to provide specific guidelines supplementing the provisions of AO No. 2020-0017 on the licensing of retailers of medical devices.