News

MALAYSIA: MDA Now Allows Multiple Authorised Representatives for A Brand Name – October, 2021

MALAYSIA: MDA Now Allows Multiple Authorised Representatives for A Brand Name – October, 2021

  • 2021-10-27 07:06:19

Effective from June 17, 2021, MDA now allows multiple authorized representatives for each medical device (brand name) placed in the market. On the other hand, they will restrict to requiring individual establishment licenses to carry out role/activity of various economic operators, as prescribed in the Medical Device Regulations 2012.

MDA Circular Letter No. 1/2014 contains two components, which are the establishment that acts as an authorized representative (AR) and the establishment that carries out various activities.

More
India: More Medical Device Categories Now Being Regulated - October, 2021

India: More Medical Device Categories Now Being Regulated - October, 2021

  • 2021-10-27 03:54:29

More medical devices are being classified under India’s Medical Device Rule 2017 based on the intended use, risk associated with the device and other parameters. They include device categories ranging from nephrology and renal care, operation theatre, pain management, personal protective equipment (PPE), software, and general hospital medical devices.

More