It is necessary to achieve an approval of Ministry of Health, Labour and Welfare(MHLW) to distribute medical devices in Japan. Getting the approval from MHLW is very difficult and complicated because it requires lots of time and costs. With this reason, medical devices from advanced companies only can get the approval. inclear—Wettrust’s feminine cleanser for the Japanese market—achieved the approval from MHLW successfully as class 2.
FDA OTC drugs are the drugs acknowledged safe and appropriate to use without supervision of a health care professional, such as a physician. In addition, people can buy OTC drugs without prescriptions. Wettrust products (inclear, gold) are acknowledged as FDA OTC Drug since 2013.
CE marking is an important procedure that guarantees product’s conformity to EU regulations. Manufacturers, importers and distributors of non-food products are obligatory to provide the CE marking if they want to trade on EU/EEA(European Economic Area). Wettrust product (wettrust Vaginal Moisturizer) achieved CE Marking in 2015.
ISO 9001 sets out the criteria for a quality management system. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.
Wettrust acquired ISO 9001 in 2013 for giving trust to customers.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Wettrust acquired ISO13485 in 2013 to meet higher international standard for medical devices.