• 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.

• 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

• 2022-08-30 03:21:56

The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.

• 2022-07-26 11:06:32

MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.

• 2022-07-26 11:03:38

Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-02-18 07:20:17

As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.