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 Post 2019, manufacturers seeking access to Canadian market must apply for MDSAP compliance as CMDCAS will be withdrawn.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.
16 May 2018
|0900 – 1300
3, Jalan Stesen Sentral,
Kuala Lumpur Sentral,
50470 Kuala Lumpur,
Early Bird Promo Code: 'EBMED'
MYR 150 / person before 30th April.
(RRP: MYR 300)
Download event flyer (PDF)