News

SINGAPORE:  Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

SINGAPORE: Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

  • 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.

More
SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

  • 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.

More
HONG KONG: Keeping Up with the MDACS - The Exclusion of Particular Devices and HSA Marketing Approval Acceptance – June/July 2024

HONG KONG: Keeping Up with the MDACS - The Exclusion of Particular Devices and HSA Marketing Approval Acceptance – June/July 2024

  • 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.

More
INDONESIA: New Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT) through Electronic Systems – June/July 2024

INDONESIA: New Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT) through Electronic Systems – June/July 2024

  • 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.

More
AUSTRALIA: TGA PUBLISHES A NEW VERSION OF GUIDANCE ON UNIFORM RECALL PROCEDURE FOR THERAPEUTIC GOODS (URPTG) – APRIL/MAY 2024

AUSTRALIA: TGA PUBLISHES A NEW VERSION OF GUIDANCE ON UNIFORM RECALL PROCEDURE FOR THERAPEUTIC GOODS (URPTG) – APRIL/MAY 2024

  • 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.

More