Case Study 28 : Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia
The Client is a US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets
April 14, 2021
No Comments
Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia
US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets
May 26, 2020
No Comments
Case Study 11: Regulatory Strategy, Gap Analysis, Classification and Registration of IVDs Kits in Australia
Regulatory Strategy, Gap Analysis, Classification and Registration of IVDs Kits in Australia
January 3, 2020
No Comments
Expansion into Japan, Australia and Brazil for American based Medical Device Company
Company Situation The Client had developed novel devices for multiple applications including for dermatology, cosmetics, plastic surgery and aesthetics. The products already had CE marking
November 7, 2019
No Comments