Household Massage Devices Compliance in the China & Japanese

Recently, a considerable number of household massage devices have been removed from Amazon Japan, simply because they failed to obtain the PMDA certification for medical devices in Japan.

In terms of global market access for household massage devices, they are basically regulated as household electrical appliances. However, some regions, such as Japan, classify them as medical devices. Most household massage devices in Japan must comply with both the Electrical Appliance and Material Safety Act and the Pharmaceutical and Medical Device Act. Then, how to find a service provider with comprehensive service capabilities to help enterprises avoid detours in entering the Japanese market?

Regulations

First and foremost, the service provider must have a good command of relevant regulations and a thorough understanding of the detailed procedures for market access, enabling manufacturers to make early arrangements.

As the world's largest production and sales market for household massage devices, China classifies such products under the scope of voluntary CQC certification, specifically in category 008005. The CQC certificate will be issued only after the product passes the type test and factory inspection.

To enter the Japanese market, products must either obtain the Rhombus pse certification or be directly exempted, depending on their power supply method.

It is crucial to determine whether a product meets the requirements of the Pharmaceutical and Medical Device Act and complete the PMDA registration for medical devices. Notably, some products can avoid PMDA registration through optimization and only need to obtain the PSE certification.

Qualifications

Secondly, the service provider must be fully qualified. This is because China's CQC certification, Japan's Rhombus PSE certification, and PMDA certification all involve product testing and factory inspections at the production site.

A fully qualified company can conduct a single test and issue two reports for both Japan's Rhombus PSE certification and PMDA certification. Moreover, with compliant ISO 13485 and ISO 9001 certifications, it can be exempted from on-site factory inspections. This simplifies the approval process, shortens the testing cycle, and saves unnecessary costs.

Experience

Finally, rationally avoiding PMDA registration largely relies on accumulated experience, as mere review of regulations may not allow for accurate judgment in all cases.

For instance, fascia guns are generally DC-powered products and thus exempt from PSE certification. Meanwhile, in accordance with the Pharmaceutical and Medical Device Act, they are required to complete PMDA registration as Class 2 medical devices. Nevertheless, based on industry experience, many manufacturers currently skip PMDA registration by adopting certain avoidance measures.

JJR LAB Solutions

JJR LAB takes a leading position in providing one-stop market access services for household massage devices.

We offer end-to-end services covering the above-mentioned items, including product testing for various certifications, assistance in factory inspections, technical documentation preparation, and QMS (Quality Management System) services. Additionally, leveraging our rich industry experience, we provide the most suitable compliance solutions for market entry.

Service Cycle

Testing Standards

CQC

①　GB4706.1 - 2005 Safety of household and similar electrical appliances - Part 1: General requirements

②　GB4706.10 - 2008 Safety of household and similar electrical appliances - Particular requirements for massage appliances

Rhombus PSE

①　J60335 - 1 (H27)

②　IEC60335 - 1:2020 + Japanese deviations

③　J60335 - 2 - 32 (2023)

④　IEC60335 - 2 - 32:2019

PMDA

①　JIS T2002:2018

②　JIS T 81001 - 5 - 1:2013

③　JIS T2304:2017

④　IEC62304:2015

⑤　J55014 - 1 (H27)

⑥　IEC 55014 - 1 + Japanese deviations

⑦　JIS T 0993 - 1:2020

⑧　ISO10993 - 1

⑨　JIS T 14971:2022

⑩　ISO14971:2019

⑪　JIS T 62366 - 1:2023

⑫　IEC62366 - 1:2015 + A1:2020

⑬　J60335 - 1 (H27), IEC60335 - 1:2020 + Japanese deviations

⑭　J60335 - 2 - 32 (2023), IEC60335 - 2 - 32:2019

Are there any specific types of household massage devices that only need to obtain PSE certification without going through the PMDA registration for medical devices?