Japan

1. Authorities

The Ministry of Health, Labour and Welfare (MHLW) of Japan regulates according to the Pharmaceuticals and Medical Devices Act (PMD Act.).

2. Relevant Regulations

Product classification reference regulations: Pharmaceuticals and Medical Devices Act (PMD Act) and Japanese Medical Device Nomenclature (JMDN) codes.

Fill in the relevant regulatory documents for the IVD product marketing application form: The Handling of Applications for Marketing Approval of In Vitro Diagnostics & Applications for Marketing Approval of In Vitro Diagnostics

Fill in the relevant regulatory documents for the MD product marketing application form: The Handling of Applications for Approval to Manufacture or Import Medical Devices & Applications for Marketing Approval for Medical Devices

QMS quality management system related regulatory documents: The PMD Act and Ministry of Health, Labour and Welfare (MHLW) Ordinance #169.

3. Time estimation

Class I General Medical Devices: <1 month

Class II Specified Controlled Medical Devices: 3-5 months

Class II Controlled Medical Devices: 7-9 months

Class III Highly Controlled Medical Devices: 9-11 months

Class IV Highly Controlled Medical Devices: 13-16 months

4. Local Representatives

Overseas manufacturers entering the Japanese market need to choose either MAH or DMAH as a local authorized representative.

5. Successful Cases

2+ Successful Cases