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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

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

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