Need guidance on registration of medical device with MHLW (Japan)

#1
Dear all,

Need to know how long (time) does it take start to finish for a new registration of sterile dental implant, assuming that all the needed regulatory documents are in compliance with the MHLW restrictions?
Another attached question is:
What is the needed re-registered time period (interval between 1st registration and the next re-registration)?
Many thanks
Nissim
 
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sreenu927

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#2
Hi Nissim,

1. Classify your device based on your products' intended use statement against the Japan Medical device regulations (General-Class I, Controlled-Class II, Highly Advanced Controlled-Class III/IV).

2. Your Market Authorization Holder (MAH) will help you to confirm your product's classification or Japan Medical Device Classification is based on Ministerial Notification#298 (July 2004), which is based on GHTF document SG1-N15.

3. I believe, dental implants fall under Class III/IV. The approval process takes 12-16 months.

4. No expiry for the approval certificate.

Regards,
Sreenu
 
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