• 2023-04-25 01:46:23

The Japanese Industrial Standard of EMC (JIS T0601-1-2) has been amended.

• 2023-04-24 09:49:39

This guidance document describes the requirements and notification process for the applicant to get approval from the Authority prior to the importation and/or market placement of custom-made medical devices.

• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

• 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

• 2023-01-19 06:20:26

Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.

Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.

• 2022-11-29 02:56:30

Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.

• 2022-10-25 07:32:01

In Australia, the “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)” and the “Reduction of Assessment Fees for Medical Devices Guideline”, both outline specific situations in which the assessment procedures and the assessment costs for medical devices may be reduced.
The guideline provides details on the criteria and the eligibility for TGA to determine whether the process can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2022-09-27 09:03:07

The pandemic has exposed supply chain vulnerabilities and issues in the medical device supply chain that were once insignificant. In this article, we compile the industry’s best practices towards achieving sustainability and resilience in the medical supply chain.