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…
Medical Device Registration in Russia
Medical Device Registration in Russia Please click here to access to Russia authority website. Please see below for the requirements. No Document Method of authorization 1 Business registration Legalization (embassy…
Indonesia Medical Device Registration Guidance
Indonesia Medical Device Registration Guidance from year 2016 Please see below for the official Medical Device Registration Guidance from the MOH authority. Contact us here for more information. Click here…
EU MDR official website
EU MDR official website There are so many articles that advise on CE MDR/ IVDR regulations implementation that most of the time, people get lost trying to find the latest…
EU MDR Technical Documentation
EU MDR Technical Documentation Updated: 19th July 2020 Please see below for example or explanation for EU MDR Technical Documentation. ANNEX II TECHNICAL DOCUMENTATION The technical documentation and, if applicable,…
How to fill up GSPR
How to fill up GSPR Updated: 19th July2020 How to fill up GSPR: GSPRDescriptionApplicable?Method appliedStandards and SolutionsEvidence7Devices shall be designed , manufactured and packaged in such a way that their…
