Testing Co. Guides Manufacturers on Categorization of Medical and Personal Care Products


SGS, the world’s leading provider of testing, verification and certification services, offers a comprehensive range of services to help manufacturers of products aimed at assisting the elderly ensure they are safe and comply with the relevant regulations.

We live in a world with an aging population. Currently there are an estimated 143 million people over 80, but this figure is expected to triple to 426 million by 2050. These people want to live independently, maintaining a self-sufficient lifestyle for as long as possible.

To cater to an aging population, industry is developing products specifically to help them live independently – for example, adult diapers and radar fall detectors. These products must be high quality and safe; they must also comply with the right regulatory standards.

What standards the product must conform to depends, very often, on whether it is classed as a personal care item or a medical device. Medical devices are defined as an instrument, apparatus, implement or piece of software that is principally intended for the purposes of diagnosis, prevention, monitoring, treatment, or alleviation of a disease, injury or handicap, on a human being.

This wide and diverse definition does not, however, cover all products aimed at elderly people. For example, it would not include adult diapers, but it would cover blood pressure monitors – both products that can easily be bought online. Medical device also covers products that are not for use by the end consumer. Instead, they are to be used only by healthcare professionals.

Manufacturers need to be certain which category their product falls under so they can ensure it complies with the correct standards. The standards that are applied to personal care items, such as adult diapers and personal hygiene wipes, are very different to those that apply to medical devices.

Manufacturers also need to work out which standards they are required to conform to within a product category. This is not always easy, as there can be a wide variety of standards that can apply. For example, in one of the fastest growing segments in the healthcare industry – wheelchairs and walking aids – what standard is enforced will depend very much on the market and the attributes of the product.

Deciding whether a product is defined as a medical device or personal care item is just the first step towards ensuring it complies with the right regulatory standards for the target market. It is often wise to partner with an experienced service provider, such as SGS, who can help to guide the manufacturer through the regulatory process. This not only ensures against incorrect categorization; it will also speed up the time to market for a product.

SGS offers a comprehensive range of services to manufacturers offering products to the elderly. Our global network of experts and testing facilities have the expertise to ensure your products are safe and comply with the correct regulations. Pierre-Jean Cavaroc is the company’s packaging and medical strategic expert for consumer and retail.

Learn more about SGS Medical Device Services.

Learn more about SGS Personal Care Services.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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