Charmaine Roson - Philippines

“Manufacturers and importers of 70% alcohol swabs will have 1 year to comply with the new requirements.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR

Published on: September 14th, 2022

Announced on September 6, 2022, FDA Advisory 2022-1576, the Philippines FDA has announced that the alcohol swabs with at least 70% isopropyl alcohol intended for antiseptic use now falls under the jurisdiction of the Center for Drug Regulation Research (CDRR) under Household Remedy Products. This comes after FDA Circular No. 2020-001 delisted alcohol swab as a registrable medical device in early 2020.  product registration of alcohol swab with 70% isopropyl alcohol are transferred from CDRRHR to CDRR.

All CPRs issued by the CDRRHR with expiration prior to July 5, 2022, shall be extended to July 5, 2023.

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Please contact us if you have questions regarding the new regulations and/or are interested in registering your product in the Philippines. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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