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
- 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.
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