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Regulations and Approval Certification of Medical Devices In order to market medical devices in Japan, a foreign manufacturer has to obtain approval certification or submit notification, depending on the classification, pursuant to PMD Act, through a Japanese Marketing Authorization Holder (MAH) or a Japanese manufacturer appointed by such foreign manufacturer
Frequently Asked Questions (FAQ) | Pharmaceuticals and Medical . . . - PMDA If you would like a formal device determination, we suggest that you contract the Marketing Authorization Holder who resides in Japan (J-MAH) first, and consult through this J-MAH with the local authority which has jurisdiction over the J-MAH, or please contact the MHLW directly
Accreditation of Foreign Manufacturers - PMDA Reviews and Related Services Outline Consultations Reviews Master File System Accreditation of Foreign Manufacturers Drugs Regulations and Approval Certification of Medical Devices Regenerative Medical Products Advanced Efforts Information for Approved Products Genetically Modified Organisms New Modalities and NAMs GLP GCP GPSP Compliance Assessments GMP QMS GCTP Inspections
スライド 1 - PMDA Designated MAH : DMAH (“Sennin seihan”) MAH designated by FRAH to conduct required quality control duties inside Japan FRAH shall have D-MAH take necessary measures for the prevention of occurrence of hazards to the public health and hygiene in Japan caused by the product
Guidance on Drug Master File System in Japan - PMDA The MF Holder must communicate with or notify relevant MAH MAA about the changes in the registered information (including the MF registration application form)
Post-marketing Safety Measures of medical devices - PMDA Article 68-2-3, Paragraph 1 of PMD Act Before marketing authorization holder (MAH) manufactures and sells medical devices which is specified by the Minister of Health, Labour and Welfare, the precautions information* which is specified by the Ordinance of MHLW must be submitted to PMDA
English-Translated Package Inserts | Pharmaceuticals and Medical . . . - PMDA Note) English-translated package insert is also available by clicking the link to "Package Insert (English) PDF ver " in the "Package insert information in Japanese" page Please note; These English translations are prepared by the MAHs The Japanese language package insert is the official document, and this translation is provided solely as a reference material In the case of any discrepancy