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As a non-European country, Turkey has long recognized European CE-marking for medical devices and in vitro diagnostic medical devices. Following the two statements issued by EU-Turkey Customs

What will the European market for medical devices look like after 2024, when EU MDR is fully applicable? What are the challenges to manufacturers, importers/distributors .......

Under the new Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDs), some IVDs* certified according to the former directive (IVDD) i.e. legacy devices can continue to be

What is the summary of safety and clinical performance about? How should this document be structured, prepared and presented to users to meet requirements of EU MDR?

Swissmedic just updated its guidance regarding the economic roles that must be indicated on the device before it is placed on the Swiss market. As a result, this buys medical device .......

Procedures for technical review and approval of medical devices, published by the Medical Device Evaluation Centre of the NMPA (Chinese competent authority).

European Commission just made a proposal for in vitro diagnostic medical device regulation regarding transitional provisions, i.e., the length of the transitional period depends on the risk .....

The pending MRA agreement between EU and Switzerland obliges foreign manufacturers to designate Swiss authorised representative, which raises the questions among the ......

What are your obligation as an importer and/or distributor if you plan to import or distribute your products in Switzerland? Very often, economic operators do not play only one role, i.e., ......

Cervical cancer remains one of the gravest threats to women’s lives worldwide. As an essential part of gold standard, colposcope plays a vital role in the diagnosis and treatment of cervical cancer.