Qualtech is a Medical Device Consulting Company and Clinical Trial Organization (CRO), with a focus on East Asia and the ASEAN nations of South-East Asia. The company was founded in the year 2000 and has served over 1000 customers worldwide during the past years. Furthermore, we hold over 1000 medical device licenses in Asia, and have acquired nearly two decades of experience. Through this experience, we are able to provide high quality and efficient services and a one-stop solution for regulatory consulting and clinical trial services.
News & Publications
Welcome to Qualtech Free Online Webinar!
The online event represents the second webinar in our 2020 series and will be held on June 17th, 2020 (Wednesday) at 11 am (GMT +8). Shall this Webinar be of interest to you or one of your colleagues, please be sure to register by using the following link (limited seats available)
[PHILIPPINES] PFDA Issues Guidelines for the Initial Implementation of Administrative Order
On January 23, 2020, PFDA released FDA Circular No. 2020-001 as initial implementation of Administrative Order No. 2018-0002 (Guidelines Governing the issuance of an authorization for a medical device based on ASEAN Harmonized Technical Requirements).
The list of registrable medical devices has been updated and classified according to risk level (A-D, low to high risk level). Some of the devices in the FDA Memorandum Circular No. 2014-005 and 005-A has been added, others deleted or reclassified or added with further descriptions. The higher the risk class, the stricter the documentation requirements. Specific provisions are listed in below:......