• 2021-05-22 04:15:04

Package inserts for all classes of medical devices and IVDs are now required to be digitized on the PMDA’s website. Devices for daily use are omitted from this requirement.

• 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

• 2021-05-22 03:37:21

The US Food and Drug Administration (FDA) has published a new policy in the Federal Register, to modify identifications of medical software in classification regulations. There are some software functions that would no longer be regulated by the FDA. The new policy is effective immediately from the date of publication.

• 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

• 2021-05-22 03:15:45

Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. This marked a milestone for both establishments and the Thai FDA team.

• 2021-04-26 03:19:54

Asia Pacific forms one of the most promising dental device markets in the world. In this edition of QT Analysis, we look into the market size waiting for you to take advantage of and the requirements to register your dental devices in this region.

• 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.

• 2021-04-26 02:48:33

In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.

• 2021-04-26 02:44:41

The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.

• 2021-04-26 02:39:59

Australia Department of Health (DoH) Therapeutic Goods Administration (TGA) has made some amendments and issued the Therapeutic Goods Amendments (2020 Measures No. 2) Act 2021, focusing on unique device identification (UDI) under Therapeutic Goods Act 1989.