• 2021-05-22 05:17:57

In April 2021, Medical Device Authority (MDA) published new guidelines for the implementation of a medical device regulator system which is listed the requirements for application for medical device advertisement approval. The guidelines are to helps the establishment to comply with the regulations Act 737. These guidelines shall be read together with Guidance Documents of Code of Advertisement (COA).

• 2021-05-22 05:11:57

According to the medical device registration conditions, any medical device that is intended for professional use may be supplied for use by medical professionals only and shall not be placed in the market for general public use.

• 2021-05-22 04:28:32

On April 20, 2021, Malaysia Medical Device Authority (MDA) published a revision list of Medical Device-Drug-Cosmetic Interphase (MDDCI) products. MDA has classified they regulated medical device and combination products that primary intended use of the device and the primary mode of action is to be used as a medical device.

• 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.

• 2021-05-22 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.