FDA Circular No.2021-014

Notifying member
Philippines
Title
FDA Circular No.2021-014
First published
24/06/2021
First EIF
26/07/2021
Latest published
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 provide guidelines on the FDA eServices Portal in applying for LTO.

Administrative body(ies) for submission of applications
Food and Drug Administration
1781 Civic Dr, Alabang, Muntinlupa, 1781 Metro Manila
https://eservices.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/190
Source
Notes
  • G/LIC/N/2/PHL/190

    FDA Circular No.2021-014 – Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems


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


    Initial, renewal and variation to License to Operate for Traders and Distributors (Wholesalers/Importers/Exporters) of medical and health related devices, equipment or devices used for treating sharps, pathological and infectious waste and water treatment devices/system.


    The FDA eservices Portal System has been developed to provide a streamlined online platform for FDA authorization applications.