• 2023-12-26 05:15:49

Qualtech's regional meeting united leaders from across ASEAN to collaborate, share knowledge, and shape the future of Qualtech in the region. The event focused on fostering unity, unwavering commitment to quality with ISO 13485 standards, and strategic planning for each country's unique needs. A cultural immersion tour of Chulalongkorn University provided inspiration and deeper understanding. The meeting concluded with a shared vision for the future of Qualtech in ASEAN.

• 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).

• 2023-12-26 02:01:02

FDA is issuing a guidance in relation to Section 506J of Federal Food, Drug, and Cosmetic Act. In which manufacturers are required to promptly notify the FDA, whether during or prior to a Public Health Emergency (PHE), of any permanent discontinuance or interruption in the production of specific devices.

• 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

• 2023-11-20 02:49:24

A regulation governing the assignment of Unique Device Identifiers (UDI) for contact lenses has been published.

• 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 01:57:54

This Q&A document answers questions on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.

• 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).