• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 2020-04-14 02:41:07

Qualtech will update you on the new expedite registration channels in China, Singapore, Malaysia, and Indonesia in the context of the COVID-19. While also introducing the existing regular fast tracks for urgently needed medical devices.

• 2020-03-16 06:50:01

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017. Medical Devices (Amendment) Rules, 2020 will be effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:48:29

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017, effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:42:41

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices. 

• 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.

• 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

• 2020-02-21 07:19:49

CDSCO India has issued an extension for several types of medical devices to register for market authorization, some until January 2021 while the other types have until April 2021.

• 2020-02-21 07:17:09

HSA released a draft guidance for software regulation last December 2019. The draft includes detailed explanation of regulation from pre-marketing approval to post market monitoring of software devices. The Singaporean authority would like to ask for stakeholder comments before official implementation

• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".