• 2021-08-01 15:44:44

CMDE has added one more step to confirm the information shown on the medical device registration certificate and its attachments in the process of technical review from June 7, 2021.

• 2021-08-01 15:22:19

The PRC State Council has issued the new regulation of Supervision and Administration of Medical Devices—or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021, creating new market access opportunities for global medical device and IVD manufacturers.

• 2021-08-01 15:11:37

Recently, NMPA issued has issued a draft Regulation on self-testing for medical device registration. It has been published for public comments.

• 2021-08-01 14:48:08

TGA's inclusion process for Class I in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 4 December 2020. This follows similar changes made on October 1, 2020, for Class I non-measuring, non-sterile medical devices. This article outlines the key changes about including Class I medical devices and Class 1 IVD medical devices in the ARTG.

• 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.

• 2021-06-25 13:10:29

China's Regulations on the Supervision and Administration of Medical Devices have undergone a series of changes recently. In this article, let's take a look at these changes and how you can prepare to implement them in your medical devices in the China market.

• 2021-06-25 13:01:35

Department of Medical Equipment and Constructions issued a draft Decree on medical devices management with a letter to collect comments on the draft Decree on March 31st, 2021.

• 2021-06-25 12:28:19

As previously notified, the CDSCO has expanded the list of regulated medical devices in India, ranging from CT scan equipment, MRI equipment, defibrillators and more, in addition to all types of implantable devices

• 2021-06-25 12:07:40

The European Medical Device Regulations has been fully enforced starting 26th May 2021, after many delays following the COVID-19 pandemic. It brings forward a set of new standards and requirements which products must comply with, to ensure a high level of public health and patient safety.