• 2024-06-20 06:42:03

South Korea boasts a thriving contact lens market. Driven by a high prevalence of myopia (nearsightedness) and a growing preference for stylish and functional eyewear, Korea presents a lucrative opportunity for global contact lens manufacturers. This article explores the factors fueling the Korean contact lens market, the reasons why it’s ripe for foreign investment, and the key considerations for success.

• 2024-06-20 06:31:57

Australia is advancing in 3D-printed medical devices, demonstrating the technology's potential in healthcare. The market, valued at $36 million in 2022, is projected to reach $132 million by 2030, driven by applications in pre-operative planning, education, orthodontics, bioprinting, and customized prosthetics and implants. These innovations enhance patient outcomes and surgical accuracy, with significant growth expected in the Asia-Pacific region.

• 2024-06-20 06:13:07

The TGA's new "Examples of Boundary and Combination Products" clarifies how to classify complex goods that blur the lines between medicines, medical devices, and biologicals. This list includes common products like injectable fillers and contact lens solutions.

• 2024-06-20 06:09:46

This announcement outlines measures to reinforce the supervision and management of commissioned production by medical device registrants, ensuring the full implementation of quality and safety responsibilities and effective risk prevention and control in accordance with regulations.

• 2024-06-20 06:05:56

Centre for Medical Device Evaluation, NMAP (CMDE) has made an announcement, on adjusting the management of digital certificate (CA certificates), aiming to fulfil the needs of current certificates management.

• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 2024-06-20 05:41:18

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

• 2024-06-20 05:24:57

This guidance outlines the requirements for sponsors submitting applications for clinical investigations and supports sponsors in developing the Investigator's Brochure.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.