最新消息

SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

  • 2023-12-26 02:27:39

Following the industrial consultation earlier this year, Cyber Security Agency (CSA) of Singapore is launching Sandbox as a voluntary trial program for Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)). This program started on 20th October 2023 and will be held for 9 months. CSA is inviting medical device manufacturers to participate in Sandbox to have a first-mover advantage in enhancing the security of their products.

The Sandbox allows all parties involved to test out and give feedback on the requirements and application process for the CLS(MD) ahead of the scheme’s launch. Along with the launch of Sandbox program, CSA also published intensive set of regulations related to the requirements and implementation of CLS(MD).

了解更多
QT ANALYSIS: PROSPECTS OF MEDICAL DEVICE INDUSTRY IN KOREA: A LUCRATIVE OPPORTUNITY FOR GLOBAL COMPANIES – OCTOBER/NOVEMBER 2023

QT ANALYSIS: PROSPECTS OF MEDICAL DEVICE INDUSTRY IN KOREA: A LUCRATIVE OPPORTUNITY FOR GLOBAL COMPANIES – OCTOBER/NOVEMBER 2023

  • 2023-10-27 01:27:54

South Korea's thriving medical device industry offers promising opportunities for companies, driven by a robust healthcare infrastructure, a growing aging population, government support, and rising healthcare spending. Qualtech invites interested manufacturers aiming to enter this dynamic market to partner with Qualtech to successfully navigate the approval process and maximize the product's potential.

了解更多
INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

  • 2023-10-20 07:21:15

In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.

了解更多
TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

  • 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

了解更多