2018 Annual BSI Medical Devices Updates

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Performance in the global medical device sector remains challenging going into 2018, due to various regulatory and economic factors. The impending enforcement of the new Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) have affected manufacturers’ near-term expectations in the EU markets. The complexities of the new Regulations as well as new, stricter requirements for Notified Bodies have created near-term challenges for companies seeking and renewing CE Marking in Europe.

Outside of the EU, the transition of the Canadian Medical Device Conformity Assessment System (CMDCAS) to the Medical Device Single Audit Program (MDSAP) draws closer to its regulatory deadline in 2019 thus affecting all major markets participating in MDSAP. Post 2019, manufacturers seeking access to Canadian market must apply for MDSAP compliance as CMDCAS will be withdrawn.

Join us in our 2018 Annual Medical Device market update and be prepared for the changes ahead.

Date:

16 May 2018

 

Time:

 

0900 – 1300
Venue:

KL Hilton

3, Jalan Stesen Sentral,

Kuala Lumpur Sentral,

50470 Kuala Lumpur,

Malaysia

 

Fees:

Early Bird Promo Code: 'EBMED'

MYR 150 / person before 30th April.

(RRP: MYR 300)

Download event flyer (PDF)


Agenda

Time

 

Speaker

0900 

Registration and refreshment

 

 

0915 

Welcome and Introduction

 

Nicklaus Au, Training Business Manager

BSI Malaysia

0930 

MDR & IVDR Update

  • Transitional arrangements
  • Technical documentation
  • Classification updates / changes
  • MDR & IVDR Conformity assessment
  • Clinical evidence and clinical evaluation / performance evaluation
  • PMS (post market surveillance) and PMCF  / PMPF (post market clinical / performance follow-up)

Hailey Chu, IVD Technical Specialist

BSI Taiwan

1030 

Refreshment

1045 

Personal Protective Equipment (PPE) Regulation Update

  • Introduction of the PPE Regulation (EU) 2016/425
    • Compliance  and implication on Manufacturers
    • Classifications
  • Changes in MDD/MDR to allow dual certification
  • Dual CE marked PPE and Medical products

Nathan Shipley, PPE Group Certification Manager

BSI UK

1130 

Medical device single audit program (MDSAP) Update

Liang Qian, Head of Med Devices, BSI Asia Pacific  BSI Healthcare (Med Tech), BSI EMEA.

1200 

Q&A

1230

Close & Lunch networking session