REGULATORY UPDATE | Transfer of Product Registration for Alcohol Swabs Containing 70% Isopropyl Alcohol

The Philippine FDA issued FDA Advisory No. 2022-1576 on September 6, 2022, announcing the transfer of product registration for alcohol swab products containing 70% isopropyl alcohol from the Center for Regulation, Radiation, Health and Research (CDRRHR) to the Center for Drug Regulatory Research (CDRR). As a result, the CDRR now oversees alcohol swabs designed for antiseptic use that contain at least 70% isopropyl alcohol.

Previously, alcohol swabs were removed from the list of registrable medical devices with the release of FDA Circular No. 2020-001, titled "Initial Implementation of Administrative Order No. 2018-0002," on January 23, 2020. In light of this change, the FDA is notifying all medical device producers, traders, distributors, and other interested parties about the transfer of alcohol swab product registration from CDRRHR to CDRR.

To ensure a stable supply of these products in the market, a transition period of one year will be granted to companies. All current Certificates of Product Registration (CPR) issued by CDRRHR that are set to expire before July 5, 2022, must be renewed by July 5, 2023.

For inquiries regarding the registration of medical devices.