日本注册

一、当局机构

日本厚生劳动省(MHLW)根据的<日本药品和医疗器械法>(PMD Act.)进行监管。

二、相关法规

产品分类参考法规：Pharmaceuticals and Medical Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes.

IVD产品上市申请表填写相关法规文件： The Handling of Applications for Marketing Approval of In Vitro Diagnostics & Applications for Marketing Approval of In Vitro Diagnostics

MD产品上市申请表填写相关法规文件：The Handling of Applications for Approval to Manufacture or Import Medical Devices & Applications for Marketing Approval for Medical Devices

QMS质量管理体系相关法规文件：The PMD Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169.

三、时间估算

Class I 类General Medical Devices：＜1 个月

Class II 类Specified Controlled Medical Devices：3-5个月

Class II 类Controlled Medical Devices：7-9个月

Class III 类Highly Controlled Medical Devices：9-11个月

Class IV 类Highly Controlled Medical Devices：13-16个月

四、当地代表

海外制造商进入日本市场是需要选择MAH或者DMAH两种任意一种的当地授权代表。

五、成功案例

2+成功案例