• 2021-10-27 06:28:50

PFDA published the list of Value Added Tax (VAT) Exempted Medical Devices affected by the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act. CREATE Act affects tax and other financial implications for corporations most especially for pharmaceutical and medical device importers, manufacturers, and distributors.

• 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

• 2021-08-02 04:35:15

PFDA held a virtual symposium where the industry stakeholders commented on two draft regulations: the addendum to FDAC 2021-002 and the list of class A medical devices. PFDA emphasized the transition period for the affected products in this symposium.

• 2021-05-22 04:20:30

PFDA shared the updated procedure for the issuance of special certification for COVID-19 test kits following recent guidance for minimum performance requirements of different types of COVID-19 Test Kits.

• 2021-03-22 02:12:12

In the light of the continuing COVID-19 pandemic, PFDA announced FDA Circular 2020-024-A which extended the validity of Licences to Operate (LTOs) and Certificates of Product Registration/Notification (CPR/Ns) that are expiring from 01 January to 30 June 2021. In addition, PFDA released key documents/announcements affecting medical device transactions to PFDA

• 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.

• 2020-12-23 01:29:16

Certificate of Medical Device Notification (CMDN) is now required to process the customs release of PPEs in addition to the LTO of the importer.

• 2020-11-26 10:29:19

PFDA launched a verification portal where interested parties and prospective clients can check list of registered products and firms.

• 2020-09-15 09:16:21

PFDA released updated new normal guidelines in relation to PFDA transactions during the quarantine period. These documents will repeal the previously released FDA Circular No. 2020-006 and its amendments.

• 2020-09-15 09:06:00

PFDA created a new portal for the Radiation Regulation Division (RRD) which will be utilized for the online transactions for radiation facilities.