Tag: Passive Implantable

CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1)     Changed Shelf Life to Shelf Validity Period

2)     Adjusted some wording

3)     Modified the definition of implanted medical equipment, consistent with the definition in “Medical Device Classification Regulation” (CFDA, No. 15).

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