USEFUL LINKS
1) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN
2) REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN
Give your business a fresh start
According to the statement made by the EU and TITCK, the new medical device regulation became valid as of 26 May 2021
From 26 May 2022, the new IVDR will apply. After this date, there will be no certification according to the old directive.
You can reach EU 2017/745 MDR and EU 2017/746 IVDR notified bodies by clicking the link below.
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
Generally it takes 2 years to get a MA for your product after NDA is done.
We can do it on behalf of you. MoH in Türkiye operates a system called UTS(product traceability system). All cosmetics product have to be registered there. Cosmetic product notification is filed to the UTS and after filing you can start selling your product in Türkiye.
Of course we can! Give us a call or send an email regarding your request. We will be back to you in a short time with a list of bidders.
Yes we can. Send us your requests via e-mail. We will send a price quote including delivery time to you.