Global Regulatory Pulse

Japan’s “Ninsho Kijun” Regulatory Approval Pathway

In Asian Market, Consulting, Regulatory by Kei Yoshikawa

Medical device products throughout the globe are characteristically classified by their specific risk level or category. This is no different in Japan, the world’s third largest medical device marketplace; however, there are important and very different considerations for manufacturers of Class II and III products in this territory than in any other part of the world.

Under the recently updated Japanese regulatory standards, medical devices with medium to high risk (Class II and III devices) are certified by Registered Certification Bodies (RCBs) which adhere to the certification standards set forth by the Ministry of Health, Labour and Welfare (MHLW), or what are referred to as “Ninsho Kijun” regulatory submission guidelines.

New classification categories under “Ninsho,” established in September 2017, include 947 certification standards which are “specified for specially controlled medical devices.”

Class II Device Considerations
The largest grouping of the two Ninsho classification categories, Class II devices, includes 935 certification standards for “specified specially controlled medical devices.” These devices are listed in Annex 2 and 3 of the MHLW Ministerial Ordinance No. 112, and each device manufacturer must address the following areas throughout the certification process:

AREA DESCRIPTION
Scope The specific JMDN category and associated requirements for certification (products listed in Annex 2/3 of the MHLW Ordinance No. 112)
Technical Standards For products listed in Annex 2, primary endpoints for evaluation of existing product equivalence must be met as specified by the MHLW notification; for products listed in Annex 3, products must also satisfy the above as well as Japanese Industrial Standards (JIS)
Intended Use / Indications Intended use or indications, and the associated certification standards to meet compliance

Class II devices are also reviewed for their conformity to essential principles and substantial equivalency related to structure, usage, indications and performance to existing Class II medical products. For devices listed in Annex 2 of the MHLW Ministerial Ordinance No. 112, compliance data is required for certification as specified in the MHLW notification.

Class III Device Considerations
There are 11 certification standards for Class III devices under Ninsho, which are outlined in Annex 1 of the MHLW Ministerial Ordinance No. 112. The following must be addressed throughout the certification process:

Area Description
Scope For products listed in Annex of of the MHLW Ordinance No. 112, specific JMDN category and associated requirements for certification must be met
Technical Standards Product listed in Annex 1 and primary endpoints for evaluation of existing product equivalence  as specified by MHLW notification
Intended Use / Indications Intended use or indications that must follow certification standards to meet compliance

As is the case with Class II medical products, Class III devices must also be reviewed for their conformity to essential principles and substantial equivalency under a product’s structure, usage, indications and performance to existing Class III medical devices. Data and reliability are also large considerations for compliance to certification standards as defined by MHLW notifications.

Preparing for Successful Ninsho Submissions
To receive Ninsho accreditation for Class II and III products in Japan, a device’s performance must meet all requirements of the corresponding technical standard with no exception. However, it should be noted that Class II devices must, almost always, comply with Japanese Industrial Standards (JIS), which are translations of ISO standards with various modifications.

If after attempting Ninsho accreditation, it is determined that a manufacturer cannot demonstrate substantial equivalency to an existing, approved device in Japan, they would be provided the opportunity to gain accreditation through the “Shonin” regulatory submission pathway, which is managed by Japan’s PMDA. (Read our blog here regarding all available regulatory submission pathways in Japan.)

Average Class II and III Ninsho review periods can range anywhere from four to six months, and typically cost several thousand dollars (USD). However, a major benefit of this type of review, versus those conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), is a drastically reduced review and certification period.

As previous mentioned, the Ninsho pathway is managed by Registered Certification Bodies (RCBs). Currently, 14 total RCBs exist throughout Japan: Seven are registered by the MHLW and the remaining seven are branches of international Notified Bodies (NBs). It is important to conduct due diligence before selecting a RCB as all offer varying timelines and costs.

NAMSA Can Help
NAMSA’s global regulatory experts are available to meet with you to discuss strategic options related to global medical device development, including identifying the best-fit regulatory strategy that help lead to successful approval and market introduction.

Some services available, include:

  • Regulatory assessment
  • Global regulatory strategy development
  • Pre-IDE meeting preparation, including development of pre-meeting packet
  • Pre-IDE meeting participation
  • Pre-market submissions: 510(k), PMA, BLA, HDE
  • FDA inspection preparation
  • FDA advisory panel preparation and meeting support

To see a full list of services provided by NAMSA, please visit our website at: www.namsa.com (U.S. visitors) or www.namsa.co.jp/ (Japan visitors).

Authors:

Kei Yoshikawa serves as Medical Research Manager at NAMSA's Japan location.