As social, economic, technological and environmental factors changes at a rapid rate, so are medical devices and healthcare equipment. The consistent changes are bringing complex challenges that require manufacturers to keep up with the rapid pace of innovations, while still maintaining safety for both professionals and inexperienced home users.
Many companies only have experience with single-country access and therefore may lack understanding and expertise of regulatory or technical requirements in other countries. With such a wide array of regulations from country to country, companies can struggle with how to begin the process of meeting the required conformity for their target markets. This issue can be compounded by a lack of internal resources dedicated to compliance issues.
In this constantly changing environment of safety, conformity, and market access requirements, it is even more important to not only respond to the regulatory needs of today but anticipate those of tomorrow.
CSA Group’s Ebook, Common Obstacles to Receiving Product Approvals for Global Markets, explores the common challenges and misconceptions in product approvals, the key stakeholders involved in the approval process, the geographical differences in the approval process, the role of a third-party testing agency, and clearing common hurdles to product approvals. To access the ebook, click here.
