On September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.
Tag Archive for: new regulations
https://asiaactual.com/wp-content/uploads/2022/10/ASEAN-compressed-version-scaled.jpg 1707 2560 Charmaine Roson https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Charmaine Roson2022-10-04 10:25:012022-10-10 15:51:25Expedited Market Access Now Available in Philippines
https://asiaactual.com/wp-content/uploads/2022/02/IVD-blood-sample-blog-cover-compressed-1-scaled.jpg 1696 2560 Charmaine Roson https://asiaactual.com/wp-content/uploads/2020/08/Growing-Medical-Device-Sales-1030x257.gif Charmaine Roson2022-09-09 10:20:422022-09-14 14:31:33Philippines FDA Publishes Revised Draft of New IVD Regulations
The Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.