On September 6 2022, The Philippines FDA issued FDA Advisory No. 2022-1576 to transfer the product registration of alcohol swab with 70% isopropyl alcohol from the CDRRHR to the CDRR. Alcohol swab with minimum concentration of 70% isopropyl alcohol are within the jurisdiction of the CDRR under Household Remedy Products.
With the issuance of FDA Circular No. 2020-001 entitled “Initial Implementation of Administrative Order No. 2018-0002” on January 23 2020, alcohol swab was removed from the list of registrable medical device. In view of this, the FDA hereby informs all medical device manufacturers, traders, distributors, and other concerned stakeholders regarding the transfer of product registration of alcohol swab with 70% isopropyl alcohol from the CDRRHR to CDRR.
To ensure the stability of supply of the said product in the market, an exhaustion period of one (1) year shall be given to the company. All existing Certificate of Product Registration (CPR) issued by the CDRRHR with expiration prior to 05 July 2022, shall be extended until 05 July 2023.
If you have any queries regarding this announcement, please contact us.