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Recently, there is increasing concern of local adverse incidents and complaints related to medical devices, which had aroused the general public awareness to the functionalities and reliability of the medical devices. Hong Kong Government is examining the safety and health risk of the medical devices and planning to introduce a new legislation to deal with the issue of control over the registration.

To enable useful preparation to the future regulatory requirements on medical device, SGS Hong Kong launches Certified Professional for Medical Device Local Responsible Person (LRP) Companies in collaboration with our regulatory specialist.

COURSE OUTLINE (2 DAYS) :

  • Medical Devices Definition and Classification
  • Types of Medical Device (MD and IVD)
  • Healthcare Nomenclature System and AMDNS
  • The Medical Devices Voluntary Listing System MDACS in HK
  • Product Registration Approval and Listing Applications to MDCO
  • Requirements and Legal Responsibilities of LRP Companies
  • COP Documentation Requirements for LRP
  • Essential Principles (EP) of Safety and Performance
  • Medical Device Labelling Requirement
  • Use of Standards for Product Design, Manufacturing and Performance Testing
  • Post Market Surveillance and Vigilance (PMS)

Click here for the Course Details. 

This coure is approved by NTTS, the approved training grant for each eligible trainee is up to HK$ 2,000.

For more detials, please contact us at:
Tel: (852) 2765 3620 | Email: hk.cbe@sgs.com