One Day Training Session on 'Meeting the New CE Mark Requirements.
Held alongside the 23rd edition of the SE-Asian Healthcare Show (19 - 21 April 2023 - KLCC) the session is designed for 'Ensuring un-interrupted exports to the EU Markets.'
With a very short time-line, Malaysian Manufacturers will need to keep abreast of these new requirements and obtain a quick overview of all that needs to be done.
Organised by Europe's leading authority on 'CE Marks' - Medical Device Safety Service GmbH (MDSS) will be on site at KLCC with a 3 man strong team. Providing individual consultation and information for moving forward.
The Team, lead by Mr Ludger Moeller will be able to ensure that all delegates are given an overview and then consultations on their specific products and requirements.
Overview:
The training sessions will cover areas within:
- New Regulations in place for Manufacturers
- Authorised Representatives.
- Scopes and Definitions
- Regulatory Aspects for market access
- Timelines
- New Hurdles to overcome
- New Responsibilities placed on the manufacturers
Attendees:
The training session is designed specifically for those involved within the export for medical devices: Export Managers, Medical Regulatory Staff and Medical Device Professionals, Pharmacist working within the regulatory and quality assurance fields.
Bhullar, the international sales director:
"It's an excellent opportunity, for a concentrated overview and one-to-one discussions to ensure continued exports to the EU."
The SE-Asian Healthcare Show is Malaysia's international trade only event for the medical industry. While, more that 95 pct of the international exhibitors are represented directly on the exhibition floor.
An overview of the Training Session is available at: