• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.

• 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.

• 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

• 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.

• 2020-10-15 05:09:36

FAQs for TFDA Good Distribution Practice (GDP)

• 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.

• 2020-08-13 02:35:55

TFDA is now collecting comments and suggestions for the drafting of “Regulations Governing Delegation or Commission of Medical Devices Test” (collecting deadline: 2020/09/07). This article presents a closer look of this upcoming regulation.