20-21 November: EU MDR Workshop

20-21 November 2019,  Connexions Bangsar South, Kuala Lumpur
REGISTER NOW

AMMI Workshop on EU Medical Device Regulations  

Venue: Connexions Bangsar South, Kuala Lumpur

Time: 9.00am-5.00pm

EU MEDICAL DEVICE REGULATION (EU MDR)

INTRODUCTION
The new European Union Medical Device Regulation (EU MDR) replaces the Medical Devices Directive (MDD) in May 2017 and the deadline for compliance to EU MDR is May 2020.

EU MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF).

This training aims to help medical device manufacturers understand the additional requirements of the standard

 

COURSE CONTENT

  • Scope, definitions and classifications
  • Conformity assessment and the role of Notified Bodies
  • General Safety and Performance Requirements
  • QMS requirements
  • Technical documentation requirements
  • Post-market surveillance, Post-market clinical follow-up, and vigilance
  • Clinical evaluation and clinical investigations
  • Transition and next steps

DURATION
Two (2) days

TARGET AUDIENCE
This training is recommended for Regulatory Affairs personnel, management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems, or involvement with product design and development.

PRE-REQUISITE
Basic knowledge of the current Medical Devices Directive and/or Active Implantable Medical Devices Directive

TRAINER
Dr Vincent Lam Chee Choong, Senior QMS Lead Auditor / Head of Medical Device Certification Scheme, TUV SUD Malaysia Sdn. Bhd

COURSE FEES:

Early Bird Fees (Registration until  10 November)
AMMI Members: RM1,600
Non Members: RM2,000

Normal Fees (Registration from 11 November onwards)
AMMI Members: RM2,000
Non Members: RM2,400

PAYMENT AND CONFIRMATION OF REGISTRATION
All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL 

 

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

CANCELLATION / REFUND POLICY
AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants/company (s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

 SUBSTITUTION
Replacement of the participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

 

CONTACT

For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347