Japan's Ministry of Health Labour and Welfare has enacted “Amendment to Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (No.63)” to introduce a set of changes in the system of supplying medical devices, aiming to bring innovative products to the market as fast as possible to help patients in Japan with deadly diseases or life-threatening illness.
One of the changes implemented on 1st September 2020 is the Fast-Track Medical Device Approval Scheme (“Sakigake Shinsa Scheme”). With the fast-track, medical device approval (“Sakigake Shinsa Scheme”), designated medical devices will receive approval 6 months earlier, where usually takes 12 months until approval, by having the designated medical devices consulted at the early stage of clinical trial and reviewed faster. The manufacturer of the designated medical devices will be appointed with a Concierge from PMDA to the company the whole process.
For a medical device to be designated for the “Sakigake Shinsa Scheme”, the following conditions must be completed and an application must be submitted to the Ministry of Health Labour and Welfare.
- (1) A medical device whose treatment or diagnosis method is innovative
- (2) A medical device that is treating a) deadly illness b) a disease which there is no cure and its symptom makes the patient have difficulty in social life
- (3) A medical device that is highly effective and safe for the targeted patient
- (4) A medical device whose manufacturer has a will and internal system to get approval in Japan earlier than every other country.
- 1. “Amendment to Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (No.63)”
- 2. Notification No.1204-01
- 3. Notification No.0831-6