Japan's Medical Device regulations

In Japan, Medical devices are divided into four classification based on the risk to the human body. Prior to marketing a medical device on the Japanese market, it must comply with the regulatory requirements of the Pharmaceutical and Medical Device Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW). 

Table of Contents

REGISTRATION
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PMDA: Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) PMDA Japan's guideline "Conditional Early Approval System for Innovative Medical Device Products”  Medical devices eligible for this system will allow for applications for approval to be submitted with limited clinical data on the assumption that applicants will implement suitable post-marketing risk management activities, such as the collection of post-marketing usage or adverse event data, or establish usage requirements. English For Sale
PMDA: Applications for Marketing Approval for Medical Devices PMDA When an application for marketing approval of a medical device is submitted by an applicant who intends to market the medical device or who intends to have an designated marketing authorization holder market the medical device according to the provisions of Article 14 and Article 19-2 of the Law, the Minister of Health, Labor and Welfare. English For Sale
PMDA: Handling of Medical Device Software PMDA Under the “Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (Law No. 145 of 1960)  amended according to (Act No. 84 of 2013,)  “Software and storage media with the software recorded” are additionally defined as medical devices. English For Sale
PMDA: New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law PMDA Japan's Health Authority the MHLW has decided to regulate non-corrective colored contact lenses also known as “non-corrective contact lenses” in a similar manner as corrective contact lenses.  The Cabinet Order listing the devices was amended and “contact lenses (excluding those intended to correct eyesight)” was added as a “medical device” regulated under the Law. English For Sale
PMDA: Points to Consider for Reprocessed Single-use Medical Devices PMDA The Ministry of Health, Labor and Welfare (MHLW) has decided to launch a new system to enable the reprocessing of single-use medical devices. English For Sale
GOOD PRACTICES
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PMDA: Ministerial Ordinance on Good Clinical Practice for Medical Devices PMDA This Ministerial Ordinance is intended to provide the standards, which serve as the GCP for Medical Device so as to ensure the scientific quality of clinical trials and the reliability of clinical trial data while the rights, safety and welfare of human subjects are protected and promoted. English For Sale
PMDA: Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices PMDA This Ordinance shall provide for matters concerning standard for conduct of nonclinical safety studies of medical devices [limited to the generation and collection of data on biological safety studies conducted at test facilities or test sites using test systems. English For Sale
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