To medical personnel

About medical care products

In compliance with the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, we display the contents for the purpose of providing information to healthcare personnel—not to patients or their caretakers. We appreciate your understanding.

Guidelines issued by the Japanese Ministry of Health, Labor and Welfare (MHLW) (excerpts)

Guidelines concerning sterilized cotton (type-3 OTC drugs, quasi-drugs)

1. Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs Cosmetics and Medical Devices (September 22, 2004, MHLW Ministerial Ordinance No.136)

2. Notification on the partial revision of Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices and Pharmacists Act (March 10, 2014, PFSD Notification 0310 No.1)
3. Notification on the approval standards for the manufacturing of newly designated quasi-drugs (November 12, 2000, PFSD Notification No.283)

Notifications on medical absorbent cotton/medical gauze

1. Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (December 17, 2004, MHLW Ministerial Ordinance No.169)

2. Notification on the standards of medical gauze and medical absorbent cotton (June 30, 2005, PFSD Notification No.0630001)

3. Notification on the amendment of the entry guideline for documents attached to the medical devices (October 2, 2014, PFSD Notification1002 No.8)

Notifications on sterilized cotton

1. Notification on the standards of quasi-drugs that do not require approval pertaining to Article 14 Paragraph 1 Pharmaceutical Affairs Law (March 24, 1997 PFSD Notification No.54)

   *Sterilized cotton is available for purchase through our group company, Cotton Labo Co., Ltd.