• 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.

• 2024-06-19 06:08:37

The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.

• 2024-05-02 01:55:12

Join our FREE webinar on ASEAN Regulatory Updates & Brazil's Medical Device Regulations. Learn how to stay compliant and enter the Brazil market! Sign up today!

• 2024-05-08 03:23:54

The TGA is streamlining therapeutic goods recalls with phase two of its Recall Reforms. This initiative aims to achieve a dual benefit: reducing the regulatory burden on sponsors and strengthening public safety.

Sponsors will experience a simplified and more flexible reporting process, while the "Early Advice" program, allowing proactive communication with the TGA, will see enhanced communication protocols.

• 2024-05-08 03:10:55

To promote consistent advertising practices across the medical industry, the TGA updated its guidelines for promoting cosmetic injectables.

• 2024-05-08 03:00:06

CMDE has issued a new notice, supplementing previous recommendations with updated clinical evaluation paths for specific medical devices, aiming to guide registration applicants effectively in navigating the regulatory process.

• 2024-04-08 08:22:03

This article explores Qualtech's strategy to achieve this feat, including navigating China's complex regulatory framework and leveraging an experienced medical writing team. The outcome is a faster market entry for Qualtech's product, offering a significant advantage in the lucrative Chinese market.

• 2024-04-08 08:12:16

This guidance aims to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.