• 2021-11-24 03:19:40

A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.

• 2021-11-24 03:09:42

MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.

• 2021-10-27 07:52:46

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

• 2021-10-27 07:25:14

Recently, MOH has introduced regulations for a total of seventeen COVID-19-related medical device categories, along with their submission dossiers and routes. Specifically, there are seven selective cases that can applied for fast approval. This circular also includes regulation on Import of medical device in view of COVID-19 prevention for purposes of aid.

• 2021-10-27 06:53:26

HSA communicated to the public regarding a cybersecurity vulnerability named "BrakTooth". It affects various IOT devices, which includes medical devices that use specific Bluetooth Link Manager Protocols. HSA shared steps to shareholders to avoid or address issues pertaining to BrakTooth.

• 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.

• 2021-10-27 05:47:59

To protect human health and the environment from Persistent Organic Pollutants (POPs), Thai FDA agreed to abide by the Stockholm Convention. In order to establish control measures, they conducted a survey of products/manufacturing processes that utilize perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, and benzyl cyanide.

• 2021-10-27 05:29:58

The “Administrative Measures for the Registration and Filing of Medical Devices” have been adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021. The measures have subsequently been promulgated and have come into effect on October 1, 2021 via Decree No. 47.

• 2021-10-27 05:22:18

A new expert committee has been formed by the Government, to frame new laws for medicines, cosmetics and medical devices in a bid to replace the existing Drugs and Cosmetics Act which was formed in 1940.

• 2021-10-27 03:54:29

More medical devices are being classified under India’s Medical Device Rule 2017 based on the intended use, risk associated with the device and other parameters. They include device categories ranging from nephrology and renal care, operation theatre, pain management, personal protective equipment (PPE), software, and general hospital medical devices.