Japan

Type A

Type B

Regulatory agency

• Ministry of Economy, Trade and Industry (METI)

Regulations

• The PSE Mark is a mandatory safety mark under DENAN Law.
• Testing by an accredited test laboratory is required.
• Category A: Specified electrical appliances and materials must be marked with the Diamond PSE Mark. Products require factory inspection and certification by a RCAB.
• Category B: Non-specified electrical appliances and materials must be marked with the Circle PSE Mark. Products do not require CAB certification.
• Compliance with JIS standards.
• EMC compliance is required for the above, where applicable.

Guidelines 

• A local importer or “Notifying Supplier” is required.
• Notifying Suppliers are responsible for:
• Submitting the Business Commencement Report.
• Confirming that the products comply with DENAN or IEC standards.
• Affixing the PSE Mark as applicable.
• Submitting product inspection records to METI upon request, etc.
• Manufacturers are responsible for:
• Conducting product inspection.
• Maintaining test equipments.
• Maintaining the product inspection records for 3 years, etc.

Applicable product categories

• The PSE Mark Category A consists of 116 items such as cables and cords, thermal fuses, battery charges, DC power supply units, etc. The PSE Mark Category B consists of 340 items such as electric irons, vacuum cleaners, washing machines, microwave ovens, television receivers, etc.
• To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Japanese requirements and obtaining the necessary approval. TÜV SÜD is a RCAB with the capability to issue the CoC for all 340 items of Category B products and 7 groups of the Category A specified products.
  
  

Regulatory agency

• VCCI Council

Regulations

• IT equipment should comply with EMC requirements under Regulations for Voluntary Control Measures*. Equipment intended for the domestic environment must comply with the Class B requirements, while other equipment should satisfy the Class A requirements.
• Test reports need to be obtained from test laboratories that are registered with VCCI.
• Testing for compliance with CISPR 22.

* Although not mandatory, it is widely supported by the Japanese industry and increasingly perceived as an indication of product quality and is highly recommended for marketing reasons.

Guidelines

EMD APPROVAL PROCEDURE

• Register and become a member of VCCI
• Obtain test report
• Submit Conformity Verification Report
• Upon approval, label products accordingly

Applicable product categories

• To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• As a MIC RCB, TÜV SÜD is able to perform testing and issue/obtain certification for manufacturers.
  
   

Regulatory agency

• The Energy Conservation Center, Japan (ECCJ)

Regulations

• Products need to comply with the standards laid out by the Energy Conservation Law which is also the basis for the Top Runner Program and the Energy-saving Labelling Program*.
• Business operators, constructors of non-residential buildings and transportation carriers also need to plan and report the status of their energy utilisation.

* Although a voluntary program, Energy-saving Labels are actively utilised in Japan and are recommended for marketing reasons.

Guidelines

• Under the Top Runner Program, manufacturers are required to surpass a weighted average value for all their products per category for each predetermined target year.

Applicable product categories

Applicable products under the Top Runner Program include:

• Air conditioners
• Computers
• Copiers
• DVD recorders
• Electric freezers
• Electric refrigerators
• Electric rice cookers
• Electric toilet seats
• Fluorescent lights
• Freight vehicles
• Gas cooking appliances
• Gas water heaters
• Magnetic discs units
• Microwaves
• Oil water heaters
• Passenger vehicles
• Space heaters
• Television sets
• Transformers
• Vending machines
• Video-cassette recorders

Applicable products under the Energy-saving Labelling Program include:

• Air conditioners
• Computers
• DVD recorders
• Electric toilet seats
• Fluorescent lights
• Freezers
• Gas cooking appliances
• Gas water heaters
• Magnetic disks
• Microwave ovens
• Oil water heaters
• Refrigerators
• Rice cookers
• Space heaters
• Television sets
• Transformers

To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Japanese requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.

Regulatory agency

• Japan Electronics and Information Technology Industries Association

Regulations

• Compliance with J-MOSS which requires marking the presence of the specific chemical substances for electrical and electronic appliances (similar to EU RoHS).
• Compliance with the Law for Recycling of Specified Kinds of Home Appliances; manufacturers are required to collect and finance recycling of their own appliances.

Guidelines

• Companies that sell a limited number of products in the market can designate other organisations to fulfil collection and recycling responsibilities on their behalf.

Applicable product categories

Applicable product categories under the J-Moss include:

• Clothes dryers
• Microwaves
• Personal computers
• Refrigerators
• Television sets
• Unit-type air conditioners
• Washing machines

To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• TÜV SÜD has the experience and capability to support manufacturers in attaining compliance according to the Japanese requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.

Regulatory agency

• Ministry of Health, Labour and Welfare (MHLW)

Regulations

• PMD Act:
• Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.
• Products must be marked with SDPPI label.

• For medical devices, the following are regulated:
• Class I products considered to be self-approved and submissions are delivered to the Pharmaceutical and Medical Devices Agency (PMDA).
• Class II products with certification criteria are reviewed and certified through a “RCB”.
• Class II (products without certification criteria), Class III and IV products need to be approved by the MHLW after evaluation by PMDA.

• For IVD reagents, the following are regulated:
• Class I reagents, considered to be self-approved and submissions are delivered to the PMDA.
• Class II reagents with certification criteria are reviewed and certified through a “RCB”.
• Class II reagents without certification criteria and Class III reagents need to be approved by the MHLW after evaluating by PMDA.

Guidelines

• A local marketing business unit is necessary. Appointment of marketing authorization holder (MAH) or designated marketing authorization holder (D-MAH).
• Registration of manufacturer’s facilities with PMDA.
• An official application has to be submitted to RCB or PMDA describing the medical device in detail.
• In the case of certification, the RCB needs to prove that the respective product requirements as stated in the "Certification Criteria" (regulated by MHLW Notices) have been met via documentation, such as the Summary Technical Documentation (STED).
• A copy of QMS conformity attestation includes MAH, manufacturing facilities and product category, which are identical to applied product, need to be attached when you submit an application.
• After audit(s) by RCB or PMDA, QMS conformity attestation, which is valid for next 5 years, is issued to the MAH.

Applicable product categories

• To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

• Within the scope of its status of RCB according to the PMD Act, TÜV SÜD Japan can conduct the certification for all applicable products.

Regulatory agency

• Ministry of Internal Affairs and Communications (MIC)

Regulations

• Manufacturers must seek an Independent MIC RCAB to certify conformity and obtain the MIC Mark. 

• Terminal equipment is divided into 2 categories – Terminal equipment for the purpose of calls and other terminal equipment.

• Radio equipment is divided into 3 categories according to legal effects – Unlicensed station, licensed station (blanket license) and licensed station (subject to simplified licensing procedure or registration).

Guidelines

• Application.
• Product testing.
• Pre-license procedures.
• Inspection.
• Issuance of license.
• The approval process also depends on the category in which the product falls under.

Applicable product categories

• To determine if a particular product is subject to the above regulations, please contact us.

Our services at a glance

As a MIC RCB, TÜV SÜD is able to perform testing and issue/obtain certification for manufacturers.