• 2025-04-24 06:13:27

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

• 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

• 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

• 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

• 2023-09-27 06:46:28

The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).

• 2022-08-30 02:54:29

The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".

• 2022-07-26 11:03:38

Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.

• 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.

• 2020-12-24 10:54:11

Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.

• 2020-02-12 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.