With the establishment of a new medical device category for lubricating gels, regulators are now outlining test methods to guide its evaluation.

The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has published and distributed the “Information Sheet on Test Methods for Personal Lubricants,” which explains in an easy-to-understand manner the performance evaluation test methods required for the approval of personal lubricant products.

Lubricating gels are Class 3 medical devices used with condoms during sexual intercourse or to temporarily reduce friction to prevent vaginal mucosal injuries. A related medical device item was newly established in August last year.

The fact sheet includes information on the types and characteristics of sexual lubricants, precautions for testing, and test examples, as well as detailed performance evaluation test methods, such as phase, osmotic pressure, viscosity, pH, and compatibility with condoms (tensile and bursting tests).

"We expect that this publication will help prepare the necessary data for quality control and item approval of personal lubricants,” the ministry said. “We will continue to actively support the rapid commercialization of new medical devices by developing international-level medical device testing and evaluation methods based on regulatory science."

People who need more information on the publication can visit the MFDS website (www.nifds.go.kr)’s Information Center and search the Publications and Publications category.