• 2021-12-27 01:30:53

TGA has introduced a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG) if they are being supplied in volumes of more than five per financial 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.

• 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

• 2021-09-29 00:25:11

In order to further standardize the generic names of medical devices and strengthen the management of the whole life cycle of medical devices, NMPA has organized and formulated six naming guidelines.

• 2021-09-29 00:18:14

Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.

• 2021-09-29 00:09:37

Back in July 2021, Indonesia’s Ministry of Health announced that oxygen cylinders that do not have thermally insulated containers and are not designated for oxygen gas, are no longer to be considered as medical devices.

• 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).