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

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

Sign Up For Our Newsletter to Stay Informed

Sign Up

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.

Grow With Us

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.

Blog Posts

Japan's Innovative Medical Device Regulatory Pathway is called Sakigake

Innovative Medical Device Registration in Japan

In 2019, Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Read more
PMDA Representative consulting with medical device manufacturers in Japan

Medical Device Consultation in Japan

Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
Read more
Australia SaMD Transition Deadline

Australia’s SaMD Regulatory Deadline

Beginning on November 1st, 2024, Australia's Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Read more