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REGULATORY COMPLIANCE

An effective implementation of a Quality Management System (QMS) is critical for your organization to deliver the highest standards to your clients. Allow us to guide you through the applications of the right QMS for your business activities: Good Distribution Practice for Medical Devices (GDPMDS) for wholesale and distribution and ISO 13485 for design and manufacturing of medical devices.

 

To import any medical devices or biological materials for your business needs, allow us to walk you through the procedures and requirements, in order to facilitate smooth logistic movements for your business. 

 

The distribution of medical devices in Singapore requires strict adherence to local regulations imposed by the Health Science Authority (HSA). Our team of regulatory expertise can assist you with the classification of your medical devices and HSA registration by preparing the technical dossier (ASEAN CSDT Format).

 OUR SERVICES 

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Medical Device Registration 
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Import Permits & Procedures
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GDPMDS and ISO13485
CONTACT US NOW

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