Under the Capacity Building Initiative for Trade Development in India (CITD) project, Four 1-day awareness programme for industry on EU requirements in respect of the Medical Devices Directive in order to be able to affix the CE Mark for export purposes has been planned in four metro cities of India. Please note this Training is being provided Free of Charges by European Experts and QCI which would normally cost at least 400 $ per day but being subsidized by Govt., There is no participation fee for these programs as these are QCI programs.

1. Capacity Building Initiative for Trade Development in India (CITD)
Medical Devices Activity
Agenda
Venue:
• Hotel Royal Plaza, 19 Ashoka Road, Connaught Place, Delhi on 23 Aug 2016
• The Pride Plaza Hotel, Judges Bungalow Road, Off S.G. Road, Ahmedabad on 24 Aug 2016
• Hotel Fortune Select Palms, 142, Rajiv Gandhi Salai – Thoraipakkam, Chennai on 26 Aug 2016
• Hotel The Lalit, Sahar Airport Road, Andheri Est, Mumbai on 27 Aug 2016
Programme: One Day Awareness Seminars on EU Medical Device Directives and
Related Regulations
Date: As mentioned above
Start Time Session Topic Objective
08:45-09:15 Course Registration
09:15-09:45 Opening Remarks
-Introduction by NABCB
-Relevant Honorable Invited Speakers
-CITD Project Objectives, Mr. Nicola Antonopoulos,
Key Expert for Technical Regulations.
Brief presentation of the CITD
project, of the present seminar,
of the speakers and their
backgrounds.
09:45-10:00 Break
10:00-11:00
What is a Medical Device or Diagnostic? The Key
Directives, Blue Guide, The Key Actors, Conformity
Assessment Procedures and the Risk Based Approach to
Classification, with examples and delegate interaction.
Introduction to the
fundamentals of EU medical
device regulation.
11:00-12:00
The Essential Requirements and Technical Documentation
– what is needed and where to find detailed guidance. The
vital importance of using standards wherever possible with
examples.
Information on the heart of CE
marking – the ERs and
standards.
12:00-12:45
The importance of ISO 13485 for Quality Management
System (QMS) implementation and ISO 14971 to Risk
Management. This will include brief comments on the
Commission Recommendation on Audits and the
International Medical Device Regulators Forum Single Audit
Program.
Introduction to the use of
global standards for QMS and
risk. Comments on
unannounced NB audits will be
included.
12:45-13:30 Lunch Break
13:30-14:00
Specific In Vitro Diagnostic (IVD) considerations to ensure
robust compliance. The use of standards and other specific
IVD guidance.
To provide useful IVD
compliance insights.
14:00-15:00
Clinical Evaluation of Medical Devices, including use of ISO
14155 for clinical investigation planning.
Introduction to clinical
evaluation.
15:00–16:00
Positive Post-Market Surveillance (PMS) and Vigilance.
Linking back to ‘CAPA’ !
Introduction to PMS for real
business benefits and what to
do if things go wrong.
16:00-16:15 Break
16:15-17:30
The new Medical Device and In Vitro Diagnostic
Regulations (MDR - 355 pages & IVDR - 306 pages)
– Important points and the direction of travel.
An introduction to the texts
published during June 2016
and pragmatic advice.
17:30-17:45
Presentation of the Indian Certification of Medical Devices
Scheme (ICMED)
NABCB
17:45-18:00 Q&A Session and Closing Remarks.