How to do Clinical Evaluation Report
How to do Clinical Evaluation Report: MDCG 2020-13 One way to ensure that your CER is complying to CE requirements is to ensure that that your CER contain all the…
Malaysia MDA Announcement
Malaysia MDA Announcement Updated: 25th August 2020 MDA ChangesDetailsAdvertisementAll advertisements that promote the medical device to general public needs to attain approval from MDA through email. LOA need to be…
EU DOC complying to EU MDR
EU DOC complying to EU MDR The below is extracted from EU MDR. Using surgical mask as an example, please see below how we can draft the EU DOC complying…
Medical Device Registration in Japan
Medical Device Registration in Japan Click here to visit PMDA (Authority) website on medical device registration in Japan. Contact us here for more information on medical device registration in Japan…
EU MDD to MDR
EU MDD to MDR Frequent made mistakes Frequent mistakes when transiting from EU MDD to MDR Did not include UDI in EC DOC Did not include the reference to OTHER…
Medical Device Registration in Bangladesh
Medical Device Registration in Bangladesh Please click here to access the Bangladesh DGDA (authority) website. The registration requirement as below: 1. Agreement between Manufacturer and Bangladesh AR 2. Original (Legalized…
