Health Canada Draft Guidance on Significant Changes: Overview
The article highlights the critical points related to the concept of significant changes in the context of medical devices allowed for marketing and use in Canada.
The article highlights the critical points related to the concept of significant changes in the context of medical devices allowed for marketing and use in Canada.
The article highlights the critical points of the new classification approach to spinal implantable medical devices.
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
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