Our Services - Medical Devices
The new Japanese pharmaceutical Law demands a Third Party Certification even for manufacturing overseas and exporting / importing of Medical and In-Vitro Devices to the Japanese Market.
Nanotechno Plaza, 572-61 Toyofuta, Kashiwa-City,
Chiba-Prefecture, Japan 277-0872
Tel: +81-4-7135-8000 / Fax: +81-4-7135-8820
Email : customer@nanotecspindler.com
Since April 1, 2005, Nanotec Spindler Co., Ltd. has been registered as Third Party Certification Body by MHLW of Japan for all Class Ⅱ categories and In-Vitro(22cat.).
We can be your stable partner for supporting your customers who export to Japan. We offer you a timely approach and to verify your Test Reports.
We test , assess , and issue your Test Reports according to CB scheme for IEC60601/JIS TO601-1. Any Medical Device using Bluetooth inland Wireless Technology can be tested and certified by us.
Scope of certification of medical device and In-Vitro diagnostic medical
- Active Implantable Medical Device applicable / not applicable JIS T0601-1
- Anaesthetic and Respiratory Device applicable / not applicable JIS T0601-1
- Dental Device applicable / not applicable JIS T0601-1
- Medical electrical device
- Institutional Medical Device applicable / not applicable JIS T0601-1
- Non Active Medical Device applicable / not applicable JIS T0601-1
- Ophthalmology and Vision Devices applicable/ not applicable JIS T0601-1
- Re-use medical device applicable / not applicable JIS T0601-1
- ingle time use device applicable / not applicable JIS T0601-1
- Home use massage device and electrical medical devices and its relating device
- Hearing Aid
- Radiation and diagnostic imaging device applicable / not applicable JIS T0601-1
- In-vitro diagnostic medical
