• 2022-01-26 04:00:20

Despite it being a criminal offense to import, supply or export medical devices that do not meet the EPSP, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. TGA Australia grants exemption in certain situations. Here we gather some FAQs related to the application of the consent for non-compliance of the medical devices and summarize this article in order to help you understand what you need to know for the condition and application.

• 2021-12-27 06:33:04

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "New CER Requirements in China". Our event is scheduled to be held on January 21st (Friday), 2022.

• 2021-12-27 06:18:36

PFDA announced that abridged route for processing of Registration and Notification Applications for Medical Devices will commence starting Nov 25. This aims to increase the efficiency of public access to safe, quality, and effective medical devices

• 2021-12-27 06:12:43

MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.

• 2021-12-27 06:04:00

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-12-27 05:12:19

MDD announced the closing of the ongoing trial scheme for expedited approval of Class II/III/IV General Medical Device Listing Application on 31 December 2021. The limit application for applicants who wish to apply through the trial scheme have been lifted.

• 2021-12-27 04:54:37

NMPA has issued a new regulation of the “Management Provision on the Self-Testing for Medical Device Registration” which include the requirements for manufacturer’s capacity for self-testing, quality management system, self-testing report and related responsibilities.

• 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

• 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.