News

MALAYSIA: MDA advise Establishments to Submit Medical Device Re-Registration Applications One Prior to Certificate Expiration Date - July 2024

MALAYSIA: MDA advise Establishments to Submit Medical Device Re-Registration Applications One Prior to Certificate Expiration Date - July 2024

  • 2024-07-30 03:35:49

The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.

More
MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July 2024

MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July 2024

  • 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.

More
THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

THAILAND: Thailand Revolutionizes Dental Care with Stricter Regulations for Safety and Quality: A Breakdown of Key Updates – July/Aug 2024

  • 2024-07-30 02:55:19

Thailand's Ministry of Public Health is enforcing stricter rules for dental devices. Specific dental products like implants and orthodontic instruments can only be sold to certified dentists and approved healthcare providers. Distributors must have selling approval certificates for transparent distribution. These changes aim to enhance patient safety and raise dental care standards, requiring quick adaptation from stakeholders.

More
South Korea's Medical Device Boom: Facts About This Lucrative Market – June/July 2024

South Korea's Medical Device Boom: Facts About This Lucrative Market – June/July 2024

  • 2024-06-20 07:07:12

South Korea's medical device market is flourishing, driven by a surge in demand for advanced technologies. This trend, coupled with a high reliance on imports (67% in 2021), creates a promising opportunity for international manufacturers of innovative devices. However, navigating this dynamic market effectively requires a strategic approach to secure a foothold in this Asian powerhouse.

More
Eye on Korea: The Booming Contact Lens Market – June/July 2024

Eye on Korea: The Booming Contact Lens Market – June/July 2024

  • 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.

More
Innovative Horizons - Australia's Journey in 3D Printed Medical Devices – June/July 2024

Innovative Horizons - Australia's Journey in 3D Printed Medical Devices – June/July 2024

  • 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.

More