Regulatory services for medical device and diagnostics companies

DKSH Healthcare Australia Pty. Limited

+61 2 9959 5533
Contact Email
Level 2, 104 Mount Street
North Sydney, NSW 2060
Australia
  • Factsheet Healthcare
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Our team of 100 regulatory healthcare experts help brand owners overcome regulatory challenges across Asia. We provide end-to-end regulatory services: from initial assessment, dossier preparation and submission to approval and then the entire range of post-marketing services that are required. 

You benefit from our broad technical registration expertise and in-depth knowledge of local regulations. We provide a single regional point of contact for all regulatory matters, as well as commercial and distribution services. 

Regulatory consulting    

Preparing smooth market entry with:

  • Regulatory feasibility assessment
  • Labeling requirement assessment

End-to-end product registration  

Handling the entire product registration through:

  • Dossier preparation
  • Compliance check
  • Product sample submission
  • Dossier submission
  • Registration follow-up and monitoring
  • Regulatory approval

Reliable regulatory partner along the entire product lifecycle   

Ensuring products follow the regulations throughout the lifecycle with:

  • Marketing Authorization (MA) holding, maintenance and transfer
  • Variations (minor and major)
  • Renewal
  • Advertising compliance check
  • Field Corrective Action Requirement for Medical Devices

Success stories

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We are proud to have expanded the business of many of the world’s leading medical device and diagnostics companies.

Our expertise

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