Risk Management Services

Overseas medical device manufacturers seeking to enter the Japanese market often find themselves in need of various resources, including regulatory and trouble-management services, to address issues in safety management.
IMI's safety management services promote safe use of medical devices in compliance with the relevant Japanese safety standards. Safety is ensured in both premarket and postmarket periods to meet the regulatory requirements and needs of medical institutions.
Overseas manufacturers can trust us with confidence in our management of the safety standards for medical devices.

Issues in the Japanese safety standards for medical devices from the viewpoint of overseas manufacturers

Premarket regulations
To start selling your products in the Japanese market, you need to apply for permission to government agencies or the Ministry of Health, Welfare and Labour. Compared with other countries, Japan is known to have a unique authorization process that requires much time and effort in order to put products on the market. This inconvenience, called a "device gap", is the main reason why the latest medical devices from abroad cannot become promptly available to medical institutions in Japan. Overseas manufacturers are also subject to certain regulations.
Postmarket regulations
In Japan, postmarket problems with medical devices are reported by medical institutions, medical device manufacturers, and medical device marketers to the Ministry of Health, Welfare and Labour, and the reporting parties have to address the problems. Not only medical institutions but also medical device manufacturers bear postmarket responsibility and cannot operate their business in Japan without fulfilling these requirements.
Issues to be considered by overseas manufacturers before entering the Japanese market
Issue to be considered by overseas manufacturers before entering the Japanese market Regurations:Pharmaceutical Affairs Law

Features of Safety Management Services

IMI's Safety Management Services aim to create a company that is trusted by related agencies and companies inside and outside Japan.

  1. For governmental agencies that regulate the safe use of medical devices, we promptly respond to their regulatory requirements through smooth communication, and investigation in order to address problems with medical devices when they occur.
  2. For overseas manufacturers, we help define requirements to address Japanese regulations so that you can introduce your medical devices into the Japanese market through the minimum number of steps possible.
  3. IMI has the same numbers of sales representatives and service engineers stationed at each service center and has connections with every kind of medical practitioner, making our dual approaches possible. Our dual approaches enable us to have close communication with medical institutions and to promptly investigate and address adverse events with medical devices when they occur.

Safety management service functions

Regulatory status in defferent coutries

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