• 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

• 2024-01-26 04:02:59

HSA is issuing Safety Alerts for all medical devices employing 5G modem due to the arising 5Ghoul Cybersecurity Vulnerabilities.

• 2024-01-26 03:40:25

The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.

• 2023-12-26 03:54:32

Starting 1st December 2023, advertisement application received in hard copy will not be accepted as all completed advertisement applications shall be sent via email to MDA.

• 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).

• 2023-11-20 02:19:57

This guidance provides clarifications on which specific regulatory considerations apply when the hardware or hardware component are classified as a medical device or an accessory to a medical device.

• 2023-11-20 01:38:47

The Medical Device Authority (MDA) announced on November 28th that the implementation of a fully electronic medical device registration certificate will start on November 1, 2023. MDA will only issue an electronic registration certificate for applications approved after November 1, 2023.

• 2023-11-20 01:26:23

Advancements in digital health technologies include the integration of AI and Machine Learning. These technologies are rapidly evolving and have a significant impact on the healthcare industry. The US FDA has released an update regarding the draft guidance they introduced on Predetermined Change Control Plans (PCCP).

• 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.

• 2023-10-20 08:57:40

The TGA is launching an initiative known as the Medical Devices Vigilance Program (MDVP). This program will kick off with a 12-month pilot phase, strategically crafted to assist medical device sponsors in adhering to regulations and assuring the Australian public that sponsors are fulfilling their obligations.