Labelling of Medical Devices (ISO15223-1)

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3048

Course Title:
Labelling of Medical Devices (ISO 15223-1)

Duration:
1 Day

Target Group:

  • The Site Inspection Readiness Team, whom will be hosting, supporting & engaged in the Inspection, includes:
  • Regulatory Affairs personnel
  • Quality Systems personnel
  • Quality Assurance personnel

 

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Labelling of Medical Devices (ISO 15223-1) by the Association of Malaysian Medical Industries

Course Objectives:
Medical Device Regulations place great importance on information supplied by a manufacturer to the user so as to ensure the safe and effective use of a medical device. This can be seen being cascaded down into ISO 13485:2016 whereby labelling comprises of the label, the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.

In order to be in compliance, the usage of standards such ISO 15223-1 in conjunction with other recognized harmonized standards (both horizontal & vertical) need to be considered together with emerging requirement on unique device identification (UDI). These requirements vary in different regulated jurisdictions. Mistakes in labeling strategy may result in rejection during market authorisation or even prosecution and/or penalties.

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Content:

  • Labelling Requirements
  • Labelling of Medical Devices ISO 15223-Symbols

 

Learning Outcomes:

  • Upon successful completion of the training, participants will be able to: Understand proper application of labelling & provision of information to the user in ensuring safe & effective use of medical device(s)
  • Labelling of Medical Devices
  • The role of harmonized a& recognized standards and the need of use of non-harmonized / non-recognized standards
  • Risk Management and Usability Engineering considerations
  • ISO 15223-1:2016 versus EN ISO 15223-1:2016
  • European Norms to be utilized together with EN ISO 15223-1:2016
  • Significance of Regulation (EC) No 1272/2008 and Regulation (EC) No 207/2012
  • Unique Device Identification per CE Marking and US FDA requirements