Registered Certification Bodies (RCBs)
Registered Certification Bodies (登録認証機関 — tōroku ninsho kikan) are Japan's equivalent of EU Notified Bodies, but their scope is more limited: they certify only Class II and certain Class III devices under the Ninsho pathway. There is no RCB involvement in Shonin (Class III/IV approval) or Todokede (Class I notification).
What RCBs do
An RCB is a third-party organisation accredited by MHLW to conduct pre-market certification (Ninsho) of devices that fall within recognised standard categories. Their role is to:
- Review the technical documentation submitted by the MAH
- Verify that the device conforms to the applicable recognised standards
- Issue the Ninsho certification if the review is satisfactory
- Conduct periodic surveillance to verify ongoing conformity
RCBs operate commercially and compete for business from MAHs. Fees and timelines vary between RCBs.
MHLW oversight of RCBs
RCBs are accredited by MHLW and must meet MHLW-set requirements for competence, independence, and quality. MHLW can suspend or revoke an RCB's accreditation for non-compliance. MHLW publishes the current list of accredited RCBs.
RCBs currently accredited by MHLW
MHLW maintains a current list at mhlw.go.jp. Major accredited RCBs include Japan Electrical Safety & Environment Technology Laboratories (JET), Japan Quality Assurance Organization (JQA), and others. Always verify the current accredited list before selecting an RCB.
Difference between RCBs and PMDA
PMDA handles Shonin applications (Class III and IV) and conducts QMS inspections. RCBs handle Ninsho applications (Class II and some Class III). They operate in parallel and independently. An MAH dealing with a Class II device will work with an RCB, not PMDA.