News

Revolutionizing Indonesia's Healthcare Landscape – An Insight into Government Mega Projects and the Medical Device Market - September/October 2024

Revolutionizing Indonesia's Healthcare Landscape – An Insight into Government Mega Projects and the Medical Device Market - September/October 2024

  • 2024-10-10 09:41:55

Indonesia is transforming its healthcare system through three major government projects: SIHREN, SOPHI, and INPULS. These initiatives aim to improve healthcare services, enhance access to specialized care, and strengthen the public laboratory system, addressing major diseases like cancer and heart disease. The projects also present significant opportunities for medical device manufacturers and regulatory consultants to align their offerings with Indonesia’s evolving healthcare needs.

More
China: New NMPA and NHC Guidelines Streamlining Temporary Importation of Urgently Needed Medical Devices in China's Clinical Settings  - August/September 2024

China: New NMPA and NHC Guidelines Streamlining Temporary Importation of Urgently Needed Medical Devices in China's Clinical Settings - August/September 2024

  • 2024-09-17 05:26:27

The National Medical Products Administration (NMPA) and National Health Commission (NHC) have issued guidelines for the temporary importation of urgently needed medical devices in clinical settings. The regulation streamlines import processes while ensuring compliance with safety standards, allowing medical institutions to quickly access essential, unregistered devices. It aligns with NMPA Orders No. 47 and 48, emphasizing patient safety and timely access to critical medical equipment.

More
HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

  • 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

More