February 17, 2020

January 8th, 2020 has marked the day of Qualtech’s extensive workshop on the new European Medical Device Regulations (MDR) for its Taiwanese clients. The event provided its attendees with the latest updates on the MDR implementation before the end of the transition period on May 26, 2020. The well-received workshop was jointly organized by Qualtech, Mr. Arkan Zwick from Croma Pharma as the main speaker, Notified Body ECM Italy, and the Asia Regulatory Professional Association (ARPA).

The new MDR regulation introduces a series of novel requirements in key areas such as stronger Notified Body oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance. Over 30 participants and household names from Taiwan’s medical device manufacturing sector have joint the event in order to be well-prepared and ready to comply with the new European requirements.

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IN PICTURE: Mr. Arkan Zwick of Croma Pharma informs participants about the key changes that the MDR will bring along. 

Mr. Arkan Zwick, the Regulatory Affairs Director of Croma Pharma GmbH, served as the main lecturer of the workshop. Mr. Zwick has more than twelve years of regulatory professional experience and is among other things responsible for CROMA’s regulatory compliance in the EU. CROMA Pharma is an Austrian medical device and pharmaceutical company, specializing in the areas of aesthetic dermatology including HA syringes, as well as in products in the area of ophthalmology.


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IN PICTURE: Mr. Roger Chen of ECM Italy discusses the current situation of Notified Bodies in Europe.

Italian Notified Body Ente Certificazione Macchine also shared its insights concerning the MDR from a notified body’s perspective. Mr. Roger Chen, Chief Executive Manager for Asia Medical Devices at ECM, introduced the organization and the opportunities under the MDR in greater detail. The workshop was further co-organized by the Asia Regulatory Professional Association (ARPA), which offers a variety of Regulatory Affairs courses and trainings to regulators as well as in a variety of universities in Asia.

Qualtech hopes that the provided workshop has successfully introduced the latest regulatory developments; and that all attendees have developed a better understanding of the transition timelines, and have learned the essentials to ensure compliance to the new landscape.