• 2021-06-24 02:55:03

We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing! Shall a CER be of interest for your business, please refer to the information within. Feel free to contact us for a first consulting session on this matter!

• 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.

• 2021-06-29 11:23:58

On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.

• 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 12:57:00

The event is taking place in the 20th year reaching its largest scale so far with more than 400 exhibitors from 35 countries and territories displacing their state-of-the-art products and services.

• 2021-06-25 12:51:04

The guidance, released as Decision No. 2426/QĐ-BYT, was constructed according to AMDD and with reference to the guidance of Singapore and Malaysia, and applicable to medical devices Class B, C, D including in-vitro diagnostic IVD MD.

• 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

• 2021-06-25 12:32:37

While the channel of distribution of a COVID-19 vaccine under the conditional approval scheme is rigorously controlled by the Thai FDA, a fast-track approval route was launched exclusively for more COVID-19 products even under the implementation of risk-classification regulation.

• 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