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).
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| PSEHB No. 0731-1 : 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: 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 |
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics | PMDA | When an application for marketing approval of an in vitro diagnostics product is submitted by an applicant who intends to market in Japan must provide adequate evidence to demonstrate the quality, efficacy, and safety of the proposed in vitro diagnostic product. | English | For Sale |
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the 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 |
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Clinical Study Data on Medical Devices from Foreign Clinical Studies | PMDA | Handling of data on the clinical studies for medical devices conducted in the foreign countries or regions, has been based on “Handling of the data of clinical studies for medical devices conducted in foreign countries (YAKUHATU No.479 Notification by Director General of Pharmaceutical Affairs Bureau dated March 31, 1997)”. | English | For Sale |
| Ministerial Ordinance 68: Good Clinical Practices (GCP) 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 |
| Ministerial Ordinance No. 36: Good Clinical Practice for 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 |