Categories: Blog
Published 15 May 2024
Deray Global Utama

REGULATORY UPDATE | Alcohol Swabs with product registration Isopropyl Alcohol 70% have been transferred from the Center for Regulation, Radiation, Health and Research (CDRRHR) to the Center for Drug Regulatory Research (CDRR)

The Philippine FDA issued FDA Advisory No. 2022-1576 on September 6, 2022. To transfer the registration of alcohol swab products containing 70% isopropyl alcohol from the CDRRHR to the CDRR, the Center for Drug Regulation Research (CDRR) now has control over alcohol swabs containing at least 70% isopropyl alcohol designed to antiseptic use, according to a statement from the Philippine FDA.

Alcohol swabs were taken off the list of registrable medical devices with the release of FDA Circular No. 2020-001, headed "Initial Implementation of Administrative Order No. 2018-0002" on January 23, 2020. Due to this, the FDA now notifies all medical device producers, traders, distributors, and other interested parties of the transfer of the alcohol swab's product registration from the CDRRHR to CDRR. An exhaustion term of one year should be granted to the firm in order to guarantee the stability of supply of the aforementioned product on the market. All current Certificates of Product Registration (CPR) from the CDRRHR that expire before July 5, 2022, must be renewed through July 5, 2023.

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