Drugdu.com expert's response:

Whether a fascia gun needs to undergo medical device certification in Japan mainly depends on its market positioning and product category.

I. Market Positioning of Fascia Guns in Japan

There are two different product definitions for fascia guns in the Japanese market:

Ordinary Household Products: If fascia guns are exported to Japan as ordinary household products, they are not required to undergo mandatory medical device certification and can be sold directly in the Japanese market.

Medical Devices: If fascia guns are defined as medical devices and exported to Japan, they will need to undergo medical device certification. In this case, the product's added value may increase and it may become more favored by the Japanese market. According to the regulations of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, fascia guns classified as medical devices fall under "designated controlled" products.

II. Certification Process for Medical Devices in Japan

According to the Pharmaceuticals and Medical Device Act (PMD Act) of Japan, the Ministry of Health, Labor and Welfare (MHLW) is responsible for overseeing and regulating medical devices in the Japanese market. The PMDA implements a classification system for medical devices, which are divided into four categories based on their risk levels: Class I (general medical devices), Class II (controlled medical devices), Class III (highly controlled medical devices), and Class IV (highly controlled medical devices with the highest risk). Different categories of medical devices follow different certification processes:

Class I Medical Devices: Implement pre-market notification (Todokede). Before going to market, the medical device marketing authorization holder must submit a pre-market notification to the PMDA, which does not require review and approval by the PMDA.

Class II Medical Devices: Implement pre-market certification (Ninsho). Before going to market, special controlled Class II medical devices require pre-market certification submitted by the medical device marketing authorization holder to a certification body authorized by the PMDA.

Class II, III, and IV Medical Devices: Implement pre-market approval (Shonin). Except for special controlled Class II medical devices, other Class II, III, and IV medical devices must be submitted for pre-market approval by the medical device marketing authorization holder to the PMDA, and can only be released to the market after approval by the PMDA.

III. Requirements for Marketing Authorization Holders

Marketing authorization holders are divided into Marketing Authorization Holders (MAH) and Designated Marketing Authorization Holders (DMAH). Both MAH and DMAH must be local Japanese companies capable of serving as product agents to assume product quality management responsibilities. Manufacturers of medical devices outside Japan must appoint an MAH or DMAH to manage their product's PMDA certification in Japan and fulfill regulatory obligations within Japan.

IV. Other Relevant Certifications

If fascia guns are sold in Japan as non-medical device products, they may need to meet other certification requirements, such as PSE certification. PSE certification is a safety certification system implemented by Japan for electrical and electronic products. As an electronic product, fascia guns may need to meet the relevant requirements of PSE certification to be sold in the Japanese market.

In summary, whether a fascia gun needs to undergo medical device certification in Japan depends on its market positioning and product category. If sold as a medical device, it will need to undergo PMDA certification; if sold as an ordinary household product, it may only need to meet other relevant certification requirements (such as PSE certification).