ASEAN Product Registration and Regulatory Bodies in the Region

Qualifying People - Developing Future

Qualifying People - Developing Future

about the Course 

The training on ASEAN Product Registration provides the understanding of requirements for manufacturers and other related service providers for documentation and product registrations in multiple countries.

Your Benefits

  • Gain an in-depth understanding of ASEAN Medical Device Directive (2015)
  • Understand the various documentation requirements  
  • Get an overview of the registration requirements for 10 countries
  • Know how to prepare technical documentation with respect to the requirements

Course CONTENT / Outline

  • Guidance to ASEAN Medical Device Directive 2015 Written for easier to understand intent / implementation
  • ASEAN CSDT – 10 countries – H.S.A. GN 17
  • Guidance on Preparation of a Product Registration
  • Submission for General Medical Device Using the ASEAN CSDT
  • How to do prepare Common Submission Dossier Template – whether it is Class I, II or III (A, B, C and D) Medical Devices or IVDD devices
  • Essential principles conformity checklist
  • Preparation of Technical File or Medical Device File for ISO13485 QMS
  • Registration in the ASEAN countries – 10 countries

Who Should Attend?

  • Medical Device Manufacturers
  • Quality Professionals
  • Regulatory Professionals QA/RA
  • Internal and External auditors, consultants, and other professionals
  • Engineering team members
  • Marketing
  • Medical device consultants or related service providers

Training duration

1 day

Pre-requisites

Basic understanding of ISO 13485:2016 may be beneficial to the participants

Examination and certification

No examination is conducted for this training program. Participants will be assessed throughout the course for punctuality and engagement in the training session. Certificate of attendance will be provided based on evaluation of the participant/s.  

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