Authorisation of medical devices in selected non-EU countries
Description
For German medical device manufacturers, markets such as the USA, Canada, Argentina, Brazil, Mexico, Colombia, Japan and Australia are becoming more and more interesting. The processes involved in registration and authorisation in the relevant countries are decisive when it comes to initial market access, as is the creation of the required documentation. The seminar provides participants with the essential knowledge they need regarding registration and authorisation conditions.
Contact Person
Goals
This seminar explains what conditions must be met in order for medical devices to be authorised by the corresponding authorities in the USA, Canada, Brazil, Mexico, Japan and Australia. Participants will gain thorough fundamental knowledge of the requirements, enabling them to handle the authorisations planned within the company in a targeted manner.
Seminar content
USA
- Legislative and regulatory overview: Legislation, organisation of the FDA, definition, segmentation
- General FDA requirements: Registration, listing, GUDID, labelling, filing
- US market: Product classification, pre-market approval, application (PMA), 510(k) pre-market notification, Investigational Device Exemption (IDE)
- Post-market requirements, FDA inspections
- Differences and similarities to regulations in Europe and distribution countries outside Europe
Canada
- Legislative and regulatory overview for Canada
- Health Canada requirements for QM systems in the medical device industry
- CMDCAS procedure versus MDSAP with transition periods
- Requirements of ISO 13485 from a Canadian perspective
- Product registration/licensing
- Classification of medical devices in accordance with MDR
- Compiling and filing documentation
Argentina, Brazil, Mexico, Colombia
- Globally harmonised requirements for the authorisation of medical devices (fundamentals from the GHTF/IMDRF principles)
- Overview of authorisation processes (registration, regulations, responsibilities, authorities, documentation requirements)
- Specific elements and requirements for QM systems (GMP/BPM) relating to
EN ISO 13485 - Classification of medical devices in these countries
- Surveillance by authorisation bodies
Japan and Australia
- Regulatory principles, documentation
- Procedure for authorisation in each country
- Country-specifics aspects
Target group / seminar duration and certificate
This seminar is suitable for exporters of medical devices, as well as staff in regulatory affairs, product development and quality management.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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