• 2020-11-26 10:42:10

The German-based “Society for Promotion of East West Knowledge Transfer” had invited the experts of Qualtech to share their knowledge on the Taiwan registration processes for medical devices and pharmaceutical products to a number of high-ranking and selected attendees. Within a 90-minute session held on November 10th, Qualtech guided participants through the different Taiwan certification procedures and further elaborated on the clinical requirements in place for pharmaceuticals.

• 2020-11-26 10:42:10

The EUDAMED actor registration module will be available starting December 2020. All the economic operators should request single registration number (SRN) through this module, including manufacturers, authorized representatives, system/procedure pack producers, and importers.

• 2020-10-19 09:39:21

Since MDR/IVDR will not automatically apply in UK from 1 January 2021, MHRA has published a new guidance document related to how medical devices will be regulated in the Great Britain after that. According to the guidance, CE marking/certification will be valid until 30 June 2023 for the Great Britain market.

• 2020-09-15 06:35:40

MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.

• 2020-06-16 07:59:23

Amid COVID-19, Japan's Ministry of Health, Labor and Welfare temporarily allows single-use parts of air ventilator to be reused under certain condition.

• 2020-02-21 07:27:21

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.

• 2020-02-12 14:01:43

In early November, CMDE has published a draft guideline for the reprocessing validation and labeling for reusable medical devices: Part 1 (hereinafter referred to as the "Guidelines") which solicited opinions from the public.

• 2020-02-14 07:52:35

In an effort to showcase the latest developments in the medical, dental and pharmaceutical industry, the MEDICAL Philippines, in partnership with Pharma Philippines and Dental Philippines will be holding a Medical Expo which serves to bring international congregation of Medical & Healthcare equipment and services, Dental Technology,