• 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

• 2023-02-23 02:02:05

According to the MDR and the IVDR, notified bodies shall make their standard fees public. In this guidance, the MDCG clarifies the requirements of the list of standard fees and provides the corresponding templates.

• 2023-02-23 01:59:23

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

• 2023-01-19 06:20:26

Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.

Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.

• 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

• 2023-01-19 05:51:33

This guidance is to assist manufacturers to implement the legal requirements related to the Periodic Safety Update Report (PSUR), which has been introduced in Article 86 of the MDR. This guidance provides the detailed information of the PSUR requirements and the related templates.

• 2022-12-27 08:46:16

This guidance is written for AR, manufacturers and other economic operators and provides clarification on relevant requirements under the Regulations.

• 2022-12-27 07:34:59

With the implementation of SATUSEHAT (the Indonesia Health System), the MoH are starting to build a Pharmaceutical and Medical Device Dictionary that will contribute to the interoperability between digital health apps and supply chain information of drugs and medical devices.

• 2022-12-27 05:30:57

To promote an effective reviewing procedure, Thai FDA granted that therapeutic medical devices shall be classified and registered under Listing (Class 1 medical device), in effect from 3rd December 2022 onward.

• 2022-11-29 03:08:35

The document sets out frequently asked questions and their answers regarding the implementation of the rules on clinical trials.