• 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.

• 2022-11-29 01:55:34

PFDA issued FDA Circular No. 2022-008 that provides a guideline on the abridged process for registration of medical devices among ASEAN member countries.

• 2022-11-29 01:39:35

The Food and Drug Administration (FDA) announced the effectivity extension of FDA Circular No. 2021-025, a guideline for application of authorization due to extended state of public health emergency.

• 2022-11-29 01:33:07

During quarter 4 of 2022, Thai FDA has announced the registration certificate renewal protocol and procedures. Medical devices with specific announcements for which CSDT have been practiced under the old policy-based regulation, will expire on 31st December 2022 and shall timely proceed with license renewal accordingly.

• 2022-10-25 03:47:11

The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2022-10-24 09:56:11

TFDA has recently announced a specific product registration guidance for AI/ML-based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software. Through the application of AI and ML-based technologies in detective or diagnostic medical devices, these kinds of products could be essential for medical personnel by decreasing required reading time with better diagnostic performance.

• 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia’s Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

• 2022-09-27 06:12:22

The Vietnam Ministry of Health released Circular No. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

• 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.