Educational course “Distribution of medical devices”
The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course "Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.
Topics
- Introduction - The Medical Devices Act within the context of the EU regulatory framework
- Placing medicinal products on the market
- medical devices generally: definition, classification, essential requirements
- stakeholders
- medical device manufacturer’s registry - procedure and documentation
- medical device registry - procedure and documentation
- notification on placing medical device on the market - notification procedure and documentation
- practical exercise: filling out of OČ-PR, OČ-MEDPRO-I, MEDPRO-II/III
- Good distribution practice of medical devices
- novelties in laws and bylaws
- medical device wholesalers registry - procedure and documentation
- good distribution practice of medical devices
- writing of standard operative procedures - basic principles
- practical exercise - filling out of OČ-VELE form, writing SOPs
Course leader
Krunoslav Kranjčec, MSc Med. Biochem., HALMED
Registration
We kindly ask you to submit the fulfilled registration form to Dr. Žarko Meštrović by e-mail: zarko.mestrovic@halmed.hr or fax on +383 1 4884 110.
Registration form
The registration form is accessible here: .doc; .pdf
We would appreciate an early registration, as the number of participants is limited (15).
Course fee
The course fee for healthcare professionals and students is 500,00 kn + VAT = 625,00 kn, for competent authorities 600,00 kn + VAT = 750,00 kn, for marketing authorisation holders and others 1000,00 kn + VAT = 1.250,00 kn.
Course fee payment
After registration, the course fee should be paid exclusively via a pro-forma invoice that will be sent to the participant by mail/fax to contacts indicated in the registration form.
The copy of the money order should be forwarded to Dr Žarko Meštrović by e-mail: zarko.mestrovic@halmed.hr, or fax on +385 1 4884 110, with the attention "For Medical device Department”.
Cancellation deadline
In case of inability to attend, the registered participant should inform Dr Žarko Meštrović on +385 1 4884 339.
