• 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.

• 2020-08-11 05:46:22

PFDA adjusted some transactions that usually requires face to face interactions. However, PFDA reminded that post-marketing surveillance activities for all medical devices will be continue.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations of the Medical Device Quality Management System. This article provides a comparison between the current and the upcoming regulation.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.