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Class I — General Medical Devices

Class I devices (一般医療機器) are the lowest-risk category under Japan's PMD Act classification system. They present minimal risk to the patient or user and do not require pre-market review by PMDA or an RCB.

Characteristics​

  • Low risk — unlikely to cause harm even if defective
  • Do not contact internal body tissues or fluids
  • Not dependent on a power source to achieve their principal intended purpose (in most cases)
  • Function independently of other active devices

Examples of Class I devices​

Tongue depressors, examination gloves (non-sterile), bandages, adhesive wound dressings (without drug), absorbent cotton, sterile gauze, hospital furniture without electronic components.

Regulatory pathway — Todokede​

Class I devices use the Todokede (notification) pathway. The MAH files a notification with the prefectural government of the prefecture where the MAH's office is located. The notification includes:

  • MAH name and address
  • Device name
  • JMDN code
  • Manufacturing site information

There is no scientific review. The prefectural government acknowledges the notification and the MAH may then begin marketing.

Post-market obligations for Class I​

Despite the light pre-market requirements, Class I MAHs still have post-market obligations:

  • Adverse event reporting to MHLW when serious events occur
  • Recall actions and MHLW notification if a safety issue arises
  • Labelling compliance with PMD Act requirements
  • Record-keeping for distribution

The QMS Ordinance (MO 169) requirements are also lighter for Class I manufacturers than for higher classes, but a basic quality system is still required.