Serbia – Clinical Trial Registration Guideline
€ 209,00
Regulamedica Guidelines are provided in English language only, however per your request we should be able to translated to other language
Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible
Description
PURPOSE
The purpose of this document is to provide orientation to the industry professionals in regard to regulatory requirements concerning medical devices clinical trials in Serbia. Furthermore, information provided might serve as starting point at investigating regulatory requirements for new product development planning.
The information has been collected by reviewing the relevant laws and ordinances as well as in direct communication with officials of national bodies and trusted user’s experiences. The guideline has been also created for purpose of providing summary of regulatory information at single location in order to save time and effort of its users.
Regulamedica® is a consulting project for “unknown user” and does not act on behalf of any National Agency, therefore formal information concerning medical device clinical trials is only provided by relevant national authority sources of information.
OTHER
Guidelines are continuously accessible online thru Regulamedica® user panel, also mobile compatible.
Table of Content
1.0 PURPOSE
2.0 SCOPE
3.0 RESPONSIBLE NATIONAL AUTHORITY
4.0 REGULATORY REQUIREMENTS
5.0 REGISTRATION STEPS
6.0 DOCUMENTATION REQUIREMENTS AND ASSEMBLY
7.0 FORMS
8.0 INFORMATION REQUIRED BY APPLICATION FORMS
9.0 APPLICATION STATUS AND REVIEW TIMELINE
10.0 REGISTRATION FEE
11.0 IMPORT OF INVESTIGATIONAL MEDICAL DEVICES
12.0 OTHER OBLIGATIONS
13.0 DEFINITIONS
14.0 REFERENCES