ISO 13485 certification in Japan

ISO 13485 certification in Japan at a glance

Medical device manufacturers serving Japan work under MHLW Ministerial Ordinance No. 169, the QMS ordinance, which was revised on 26 March 2021 to align with ISO 13485:2016. That alignment lets one quality management system serve the Japanese regulatory route and export markets, provided the records show both sets of requirements are met. Compliance with the ordinance remains a regulatory matter for the Ministry of Health, Labour and Welfare and the PMDA; an ISO 13485 certificate is issued separately, by an accredited certification body, after stage 1 and stage 2 audits that examine risk management, design controls where applicable, supplier control, process validation and post-market processes. Component suppliers and contract manufacturers increasingly face the same expectations through their customers' supplier agreements. Sterling builds the system from its Tokyo office around the device's technical documentation and the ordinance's structure, with Effivity and Sterling Academy included, and confirms current regulatory requirements at the start of each project.

Who needs ISO 13485 in Japan, and what happens without it

In Japan the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.

• Medical device marketing authorisation holders and registered manufacturing sitesThe MHLW QMS ordinance was revised to align with ISO 13485:2016.
• Overseas manufacturers supplying the Japanese marketAligning one QMS with both ISO 13485 and the QMS ordinance avoids parallel systems.
• Component and contract manufacturers for device makersDevice makers extend quality requirements to suppliers.

ISO 13485 requirements in Japan

Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.

In Japan these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →

• ISO 13485 requirements, clause by clause in plain language

How to get ISO 13485 certified in Japan

One team from the Tokyo office carries the work from scoping to certificate. Nationwide from the Tokyo office, on-site where the scope requires; remote delivery for distributed teams.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO 13485 and the Japanese requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
5. Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• The ISO 13485 certification process, step by step
• ISO 13485 internal audit

How long does ISO 13485 certification take in Japan?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Japan these are the factors that set the timeline.

• Device classification and whether design is in scope
• Gap between the QMS ordinance and ISO 13485:2016 records
• Supplier, sterilisation and process validation evidence

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• Scope and timeline estimator

How much does ISO 13485 certification cost in Japan?

The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In Japan these factors move both.

• Number of sites and device families
• Certification body audit fees quoted separately from consulting
• Extent of design and process validation work

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 13485

ISO 13485 consultants and certification bodies in Japan

Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Japan are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 13485 in Japan: questions clients ask

More on ISO 13485 for Japanese organisations

• ISO 13485: the complete guide
• Watch: How to implement ISO 13485
• Sterling in Tokyo
• ISO 13485 certification in Japan and every other standard Sterling delivers there

Other standards Japanese businesses ask Sterling for

Organisations in Japan often combine ISO 13485 with one of these, under one management system where the scopes allow.

All 21 standards Sterling delivers in Japan →