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# Japan Industrial Safety and Health Act (ISHA): What Machinery and Equipment Makers Must Know

ISHA runs parallel to PSE and applies specifically to machinery and equipment in occupational settings. For industrial electronics and machinery companies, understanding where ISHA obligations begin — and how they interact with PSE and CE — is essential before entering the Japan B2B market.

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At a glance

Law

Industrial Safety and Health Act (ISHA)

Administrator

MHLW

Categories

Specific machinery (Class 1) + hazardous electrical equipment

Certification

Registration certification body (third-party)

## What ISHA covers and how it applies to equipment makers

### Specific machinery subject to ISHA

Class 1 specific machinery — including boilers, first-class pressure vessels, cranes, lifts, and certain construction machinery — requires pre-use inspection and manufacturer certification before deployment in Japanese workplaces. The ISHA ordinance on industrial safety defines the specific types and capacities that trigger this requirement. Manufacturers of these categories must work with a registered certification body before their equipment can be put into service in Japan.

### ISHA-regulated electrical equipment

Certain electrical equipment used in hazardous areas (explosive atmospheres such as chemical plants, mines, and grain handling facilities) must meet ISHA technical standards independently of PSE certification. ISHA also applies to equipment used in construction and civil engineering contexts. The MHLW technical standards for explosion-proof and intrinsically-safe equipment align broadly with IEC 60079 but are administered separately from the DENAN (electrical safety) system that governs PSE.

### Registration certification body (Tokkei) system

Third-party certification bodies registered with MHLW — known as Tokkei — certify specific machinery covered by ISHA. This certification is distinct from PSE, which routes through the DENAN framework and METI. Tokkei organisations examine design documentation, witness testing, and issue manufacturing certifications that allow the equipment to be legally installed and operated in Japanese workplaces.

### Self-inspection obligations for equipment users

Japanese workplaces are legally required to conduct annual self-inspections of specified equipment under ISHA. Equipment manufacturers are expected to support this by providing Japanese-language inspection manuals that detail inspection procedures, maintenance schedules, and pass/fail criteria. Equipment that ships without adequate Japanese-language inspection documentation creates compliance problems for the buyer and potential liability for the supplier.

## Steps to assess and meet ISHA obligations for your product

01

Determine whether your product falls within ISHA-specified machinery or equipment categories. The ISHA Ordinance on Industrial Safety lists specific machinery categories by type, capacity, and working environment. General consumer electronics and standard industrial automation that does not involve explosive atmospheres, high pressure, or heavy lifting mechanisms is typically outside ISHA scope.

02

If your product is industrial machinery — such as cranes, pressure vessels, industrial laser systems, or large-capacity lifts — engage a Tokkei (registered certification body) for pre-market certification. Tokkei organisations can be identified through the MHLW website. They review design documentation, technical specifications, and test evidence before issuing manufacturing certificates.

03

For industrial electrical equipment used in hazardous atmospheres, confirm compliance with MHLW technical standards for explosion-proof (防爆) or intrinsically-safe equipment. These standards are separate from PSE requirements. Equipment bearing CE marking with ATEX certification will still require separate ISHA verification — CE and ATEX do not substitute for Japanese ISHA technical standards.

04

Prepare Japanese-language instruction manuals covering self-inspection procedures, maintenance intervals, and safety precautions. Japanese industrial buyers expect comprehensive Japanese documentation as part of the product delivery — inadequate documentation is a frequent source of post-sale disputes and affects customer qualification of the equipment.

05

Coordinate with the Japanese industrial distributor or trading company (shosha) on ISHA compliance obligations. Shosha are experienced in managing customer-side registration and inspection requirements and can advise on which ISHA obligations are typically managed by the supplier versus the end-user in your product category.

## Frequently asked questions

### Does ISHA apply to industrial robots and automation equipment?

Industrial robots used in Japanese workplaces are subject to ISHA's provisions on industrial machinery safety, though they do not fall within the specific machinery categories requiring Tokkei pre-certification. Instead, ISHA imposes installation and operational safety requirements — including risk assessment, guarding, and operator training — managed by the workplace operator rather than the manufacturer. However, manufacturers are expected to provide Japanese-language risk assessment documentation and guarding specifications as part of the product package. For collaborative robots (cobots) used without guarding, MHLW has issued specific technical guidelines that apply under ISHA.

### How is ISHA different from PSE certification?

PSE (Product Safety and Electrical Appliance) certification is a consumer and general commercial safety scheme administered by METI under the Electrical Appliance and Material Safety Act (DENAN). It covers electrical appliances sold to end users in Japan — from consumer electronics to industrial electrical tools. ISHA is a workplace safety law administered by MHLW that applies to machinery and equipment used in occupational settings, focusing on worker protection. PSE and ISHA can apply simultaneously to the same product — for example, an industrial power tool may need both PSE certification (as an electrical appliance) and ISHA compliance (as workplace machinery).

### What is a Tokkei and when is their certification required?

Tokkei (登録型式検定機関) are registration-certified type examination bodies recognised by MHLW under ISHA. They are required for Class 1 specific machinery — principally boilers, first-class pressure vessels, cranes above a certain capacity, lifts, and certain construction machinery. The manufacturer must submit design drawings, materials specifications, and test evidence to the Tokkei, who examine and certify the design type. Each unit produced must also undergo an individual inspection. Tokkei certification is not required for general industrial equipment that does not fall within ISHA's specific machinery definitions.

### Does ISHA affect electronics products that only have CE marking?

CE marking demonstrates conformity with EU directives and is not recognised as equivalent to ISHA compliance in Japan. For electronics products sold into Japanese industrial settings — particularly those used in explosive atmospheres or as part of high-risk machinery — ISHA technical standards apply independently of CE. However, for general industrial electronics (PLCs, sensors, control systems, industrial computers) not used in explosive atmospheres and not constituting specific machinery, ISHA's primary impact is documentation: Japanese workplace operators need Japanese-language safety and maintenance documentation to meet their ISHA self-inspection obligations.

**Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions.

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