Di(2-ethylhexyl)phthalate and Bisphenol A Testing for Health Canada Medical Device Licencing

Intertek offers DEHP and BPA testing services for Health Canada medical device licensing requirements.

All manufacturers of licensed Class II, III and IV medical devices are required to inform Health Canada as to whether their devices contain more than or equal to 0.1% by mass of DEHP or are manufactured from raw materials containing or derived from BPA. The specific requirements are listed in the Health Canada licensing forms applicable to medical devices.

DEHP and BPA Testing for Health Canada Medical Device Licensing

Intertek, a global leader in restricted materials compliance, provides di(2-ethylhexyl)phthalate (DEHP) testing and bisphenol A (BPA) testing for the purposes of medical device licensing in Canada. Testing is available through Intertek’s global network of laboratories supporting companies in North America, Europe, and Asia.

For companies with a global sales footprint looking for cost savings, Intertek's DEHP and BPA testing can be expanded to include testing for the EU RoHS Directive and Substances of Very High Concern (SVHC) for the EU REACH Regulation, enabling larger market access with a small expanded effort.