Lisa L. Michels, General Counsel and regulatory affairs expert, Regulatory Compliance Associates Inc. 05.01.17
The global medical device regulatory landscape is constantly evolving as governing bodies and/or agencies worldwide continue their efforts to harmonize and streamline rules. Over the last several years, many of these regulatory bodies have joined forces to ensure consistency in the interpretation, application, and implementation of relevant medtech regulations and globally recognized consensus standards. While such efforts have considerably improved the product registration process overseas, harmonization in some cases has made it difficult for some device firms to stay abreast of the planet’s evolving regulatory landscape.
To remain competitive in this challenging environment, medtech companies stay ahead of the competition by proactively planning for new and/or changing global regulations that can help them successfully launch existing, modified, or novel products in new target markets.
Common Registration Obstacles
Most companies want their products to be registered in as many global markets as possible, but this lofty goal introduces certain regulatory challenges. From a g
To remain competitive in this challenging environment, medtech companies stay ahead of the competition by proactively planning for new and/or changing global regulations that can help them successfully launch existing, modified, or novel products in new target markets.
Common Registration Obstacles
Most companies want their products to be registered in as many global markets as possible, but this lofty goal introduces certain regulatory challenges. From a g
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