• 2020-11-09 10:51:43

Post-market surveillance has become an inexorable trend around the globe.
Therefore, proactively collect and track the following information of your products is essential and crucial.
-Relative post-market incidents reported (e.g. alerts, AEs, recalls)
-Relevant clinical literatures

• 2020-10-27 06:10:24

The Qualtech team is happy to announce that Europe-Taiwan Biotech Association and Society for Promotion of East West Knowledge Transfer invited our specialists to share their medical device and pharmaceutical products registration experience at the International Online Conference on November 10, 2020.

• 2020-10-29 05:46:11

Qualtech has started providing regulatory services for medical device manufacturers who aim for the Japanese market. Taking this opportunity, we would like to provide a brief introduction of what Japanese regulation requires for foreign manufacturers to sell their products in its market.

• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-10-21 01:59:48

Malaysia Medical Device Authority (MDA) published a new circular letter on the policy implementation and enforcement for the refurbishment of medical device and effective immediately. The policy decision to ensure the safety and effectiveness of the refurbished medical devices itself.

• 2020-10-21 01:42:37

Food and Drug Administration urgently announced certain control measures for powdered surgical gloves regarding the technical issues of the powder used in manufacturing process which may cause serious adverse effect to end-users or patients.

• 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

• 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.

• 2020-10-15 05:09:36

FAQs for TFDA Good Distribution Practice (GDP)

• 2020-09-15 09:26:39

In Vietnam, the fees for processing applications for license to sell and import medical devices will be reduced 30% from July 8th 2020 to December 31th 2020.