Search results
Other Related Information. New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law [51.46 KB] Issuance of Certificates for Medical Devices for Export [33.22 KB] Revision of Japanese Medical Device QMS requirements.
- Standards for Medical Devices in Japan - PMDA
Standards for Medical Devices in Japan. What's New....
- Regulatory Updates on Medical Devices in Japan - PMDA
Overview of Amendment of the Pharmaceuticals and Medical...
- Pharmaceuticals and Medical Devices Agency - PMDA
Clinical trials, reviews, consultations, compliance...
- Standards for Medical Devices in Japan - PMDA
Clinical trials, reviews, consultations, compliance assessments, and inspections concerning applications for drugs, medical devices, regenerative medical products, etc.
10 maj 2024 · Standards for Medical Devices in Japan. What's New. [2024/09/17] ＜MD＞2 Japanese Medical Device Nomenclatures (JMDN) are established and one is revised. [2024/08/23] ＜MD＞One Japanese Medical Device Nomenclature (JMDN) is established. [2024/08/15] ＜MD＞Information about Standards is updated.
Overview of Amendment of the Pharmaceuticals and Medical Devices Act (PMD Act) Promulgated in November, 2019 Implemented in September, 2020. Following provisions are introduced : SAKIGAKE designation system. Priority review for specific uses, e.g. pediatric use. Conditional approval system.
29 lis 2023 · Japan has a well-structured regulatory framework to ensure the safety, quality, and efficacy of medical devices marketed within its borders. A deep understanding of this regulatory landscape is crucial for manufacturers aiming to navigate the registration process smoothly.
TÜV SÜD Japan is a registered certification body (RCB) for medical devices in Japan, and can provide assessment, quality management systems (QMS) audits, and certification for medical devices as required under Japan’s PMD Act.
Medical device registration in Japan is overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) of the Ministry of Health, Labor and Welfare (MHLW) under the newly revised (last revision: 2014) Pharmaceutical and Medical Device Law (PMDL), formerly the Pharmaceutical Affairs Law (J-PAL).
