NHRA Bahrain


These e-workshops will give an introduction, overview and latest updates on medical devices regulation in Bahrain. NHRA experts will prepare 7 webinar modules that will be covered within 7 days (22-28 July). Each webinar will last 1 hour and contain presentations and Q&A time. All participants will have a unique chance to address their questions to the NHRA team. At the end of each session, participants will have a multiple-choice questions exam. The top 5 candidates will receive a place to be part of the NHRA private market representative Medical Devices committee. At the end of the course all participants will receive an attendance certificate.

NHRA Medical Devices Regulation Recorded Webinars

DATE
MODULE TITLE
TOPICS
SPEAKER NAME
AUDIENCE
22 July
Authorized representative (AR)registration
1- Introduction
2- How to obtain medical device import/sales/export licence or register as an authorized repressive
3- What are medical devices Storage regulation
4- What are medical devices Manufacture regulation
5- RENEWAL
Eng. Omar Mohamed
importers, distributors, manufacturers
23 July
Medical device registration
1- Updates on the NEW FORM
2- NEW GUIDELINE
3- Outsourcing registration file review
4- How and who can apply for Medical device registration
5- How many devices I can submit in one file (BUNDLING method)
6- RENEWAL and VARIATION
Eng. Abdullatif Alnaser
Mrs Saeeda AlJaberi
importers, distributors, manufacturers
24 July
Quality assurance certificate (QAC) verification
1- Introduction
2- How to verify QAC
3- How to show NHRA the verification
4- EXAMPLES
Eng. Abdulla Aldoseri
Healthcare facilities, importers, distributors, manufacturers
25 July
Medical device importation
1- Introduction
2- requirement
3- How and who can apply on ofoq
4- What action are recoded as a violation
Mr.Abdulla Saeed
importers, distributors, manufacturers
26 July
Medical device Classification
1- Updates on MDR during Covid-19
2- Introduction about combined medical device term cancelation
3- What to classify when and how many times
4- Classification requirements
5- How to apply
Eng. Nada Ghassan Alsayegh
Mrs.Sabeeka Alnoaima
importers, distributors, manufacturers
27 July
Permit to use (PTU)
1- Introduction
2- How and when to apply for PTU
3- PTU phases
Mr.Khaled Bukhamas
Healthcare facilities, importers, distributors, manufacturers
28 July
Post market surveillance (PMS)
1- RECALLS AND FSN
2- REPORTING ADVERS EVENT
3- COMPLAIN HANDELING
4- ACTIONS TO BE TAKEN
5- CIRCULAR 24 PMS COMMITTEE 1st date of meeting announcements and meeting agenda
Eng. Wesam Abdelzaher
Healthcare facilities, importers, distributors, manufacturers

NHRA SPEAKERS

Nada Ghassan Alsayegh

Eng. Nada Al Sayegh


NHRA Bahrain

Eng. Omar Ismaeel

Eng. Omar Ismaeel


NHRA Bahrain

Eng. Wesam Mamdouh Abdelzaher

Eng. Wesam Mamdouh Abdelzaher


NHRA Bahrain

Khaled Ahmed Bokhammas

Khaled Ahmed Bokhammas


NHRA Bahrain

Eng. Abdullatif Khaled Alnaser

Eng Abdullatif Khaled Alnaser


NHRA Bahrain

Saeeda Isa Al Jaberi

Saeeda Isa Al Jaberi


NHRA Bahrain

Mrs. Sabeeka Al.Noaimi

Mrs. Sabeeka Al.Noaimi


NHRA Bahrain

Abdulla M. Aldoseri

Abdulla M. Aldoseri


NHRA Bahrain

Abdulla Abdulrahman Abdulkarim

Abdulla Abdulrahman Abdulkarim


NHRA Bahrain