AUTHORITY ON ALCOHOL SWAB PRODUCTS
Antiseptic alcohol swabs with 70% isopropyl alcohol have been affiliated with both drug and medical device products. However, under the Household Remedy Products of the Center for Drug Regulation and Research (CDRR), alcohol products with 70% isopropyl alcohol are within their authority.
Upon issuance of the FDA Circular No. 2020-001 entitled “Initial Implementation of Administrative Order No. 2018-002”, a guideline governing the issuance of an authorization for medical devices based on the ASEAN harmonized technical requirements, alcohol swabs were delisted as registrable medical device.
In recognition on the said regulatory reform, PFDA released the FDA Advisory 2022-1576 to inform all related and concerned stakeholders that the product registration of alcohol swabs with 70% isopropyl alcohol will be transfer from the Center for Device Regulation, Radiation Health, and Research (CDRRHR) to CDRR. And will be given a one (1) year transition period.
PFDA ePORTAL SYSTEM FOR MEDICAL DEVICE RETAILERS
PFDA’s eServices Portal System has been developed to provide a streamlined online platform for FDA Authorization applications. The FDA Circular No.2022-007 has been issued as a guideline for the updated function of the portal by including the LTO application for retailers of Medical Devices
The following are the scopes of the circular that should be observed by retailers for LTO applications
- 1. Type of Establishments
- • Retail stores for medical devices
- • Clinics that sell products classified as medical devices except those that are covered by the DOH One Stop Shop Licensing System
- • Sellers of products classified as medical devices through online shopping websites and social media platforms with physical office
- • TV shopping companies that sell or offer to sell medical device directly to the public
- • Optical shops
- • Drug outlets, such as drugstores, and retail outlets for non-prescription drugs (RONPD) that also sell or offer to sell medical devices
- 2. Type of LTO applications
- • Initial
- • Renewal
- • Variation
Other technical requirements and other guidelines relative to the licensing of establishment in accordance with their compliance with the FDA regulation will be provided in Administrative Order (AO) 2020-0017 and FC No. 2021-021.
- PFDA transfers Alcohol Swab Registration from Medical Device Division to Drugs Division
- PFDA Guidelines on using ePortal System for Retailer LTO Application