A third-party certification system for low-risk medical equipment will be introduced through Japan’s Pharmaceutical Affairs Law (PAL) revisions within the next two years. Products designated by the Ministry of Health, Labor and Welfare (MHLW) as medical equipment requiring controls, or Designated Medical Equipment Requiring Controls, will shift from ministerial level approval to approval by designated third parties.
Medical devices that previous fell into Risk Class II, and are designated as medical equipment requiring controls will only need to receive certification of compliance with specifications by a third-party certification organization. Certification standards will be based on basic requirements, technical standards, and the Japan Industrials Standards (JIS). However, details regarding what specific products will qualify as Designated Medical Equipment Requiring Controls and the procedures for certification have yet to be announced. The MHLW will assign a new agency, the New Independent Administrative Agency, to appoint appropriate bodies to conduct third-party review.