DNA Genotek's Sample Collection Blog

Going global: how our regulatory strategy helps genetic research

Posted by Shauna White on Thu, Apr 24, 2014 @ 13:04 PM

Regulatory strategy - OrageneIn a recent article on The Genetic Link, we talked about our quality and regulatory process and the benefits this brings to our customers. Today, I am focusing on the work we do behind the scenes to make sure our products can be used by researchers around the world.

We know that many customers are collecting DNA samples in both urban and remote locations all over the world. We frequently see our products purchased in one country and then shipped to another country (or countries) for DNA collection. For example, it’s not unusual for a customer in the United Kingdom to purchase our collection and stabilization products and ship them to Africa for a specific research project. With customers in more than 100 countries, we have worked and continue to work with regulatory agencies worldwide to ensure we can ship our products where they are needed.

While this may seem like a simple shipping logistics issue, it is much more complex because in many jurisdictions around the world, DNA collection products such as our Oragene products may be classified as medical devices or in vitro diagnostic products. National regulatory bodies have put in place guidelines that impact the ability to ship medical devices into many countries without the proper marketing approvals, device licences and/or manufacturer certifications. In an increasingly global market, sifting through the many regulations, directives and guidelines can seem a daunting task. However, with the global requirements of our customers, understanding global medical device regulations has become more important than ever. Knowing how to achieve and maintain regulatory compliance within the many overlapping international regulations is critically important for us, as a manufacturer.

We have a dedicated team of regulatory professionals  at DNA Genotek who are responsible for ensuring our products are in compliance with the appropriate regulatory guidelines. In some cases, it takes years of effort to secure the appropriate regulatory clearances and approvals. We successfully achieved CE marking status in the European Union as well as regulatory approvals in China, Brazil, Argentina, Taiwan, Japan, Israel and Thailand. We continue to work in other countries to secure the appropriate regulatory clearance and approvals.

So what does this mean for our customers? They can feel confident that DNA Genotek has a global regulatory plan that will help them stay in compliance with various regulatory bodies. This can save significant time, energy and money in completing genetic projects.

Where do you need to ship your DNA Genotek products? Whether it’s Brazil, China, Japan, Mexico, Korea or somewhere else, we can help make sure your DNA Genotek products can enter new markets quickly and cost effectively. Our global regulatory strategy may mean the difference between a smooth shipment of DNA collection kits or a huge headache. This allows you to focus on your valuable research and make discoveries vital to improving global healthcare.

Tags: DNA saliva, genetic research, genotyping

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This blog is intended to provide information to educate readers about molecular testing and genetic sample collection and DNA Genotek products.  Some of the information on this blog represents emerging scientific research or data developed for research purposes only. More information here.

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Welcome to The Genetic Link, a blog providing new insights into DNA and RNA sample collection by DNA Genotek. DNA Genotek is a subsidiary of OraSure Technologies, Inc.

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