Expanding your brand to Europe, the largest cosmetics and personal care market in the world, may seem a challenging task at first. However, retail sales valued at €77 billion in 2016 is worthy incentive for any company considering this market. Pre-market registration is required for cosmetics in the European Union (EU), where the EU cosmetic regulations define requirements to be fulfilled before entering the market. One set of regulations for multiple countries simplifies the overall process, but executing the requirements without experienced help can be frustrating. The EU cosmetic … [Read more...] about Launching your cosmetic product in the EU
Companies interested in distributing a medical device in the USA for the first time are likely to have some questions regarding the process. The FDA has several types of premarket applications that allow legal market access for devices to the USA. The following article provides a high-level overview of the two most common applications, highlighting when each type is most likely to be used. Which pathway should be used? The FDA has classified around 1700 different types of generic devices (classes I to III), based on the level of risk they present to patients. Most class I devices (e.g. … [Read more...] about 510(k) or PMA? – How to know which pathway is best for your device in the USA
One of the most common questions from clients looking to enter the Canadian natural health market is, “What do I need to include on my label?” Most prospective sellers are familiar with the requirement for French text on Canadian labels, but a common misconception is that label content (claims, ingredient listings, graphics) may remain the same as is used for the product in other markets. To the contrary, Health Canada strictly regulates label content for natural health products, and, in addition to French text, specific labelling regulations need to be met before selling a natural health … [Read more...] about Labelling your natural health product for Canada.
The rapid evolution of technology in today’s world stimulates innovation in many industries, including healthcare products and services. The proliferation of technology is changing the way consumers and professionals think about and approach health. In an increasingly tech savvy world, it is no surprise that consumers are looking to have instantaneous access to information at a swipe of their fingertips. Technology enables this in healthcare, and consumers now have more visibility of personal health data than ever before. This empowers them to participate more actively in medical … [Read more...] about The Rise of Technology in Health Care
What happens when you find yourself, a Canadian natural health product (NHP) brand owner, manufacturer, or importer, without the in-house experience necessary to meet Good Manufacturing Practice (GMP) guidelines? Large and small companies alike struggle with GMP and quality assurance (QA) from time to time – sometimes as a result of being new to industry and GMP requirements, and other times due to staffing shortages, employee leaves, changes to your products or systems, or the scale of your business not requiring a full-time quality person. Do you need to close up shop until you have a … [Read more...] about Help! I don’t have a QAP or GMP is news to me.
Along with consulting on regulatory and quality solutions, we aim to simplify terminologies and concepts in the life science industries for our clients. Unique device identification (UDI) for medical devices has been gaining visibility in the market, and is accompanied by the reoccurring questions “what is it?” and “do I need it?” We write here to provide a high-level overview of UDI for our medical device clients. What is a UDI? A UDI is an identification code used to identify and trace medical devices throughout their distribution and use. The United States Food and Drug … [Read more...] about Demystifying unique device identification (UDI) for medical devices