[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.40]
[Page 256]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 26 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
Subpart B Specific Sector Provisions for Medical Devices
Sec. 26.40 Start of the operational period.
(a) The operational period will start at the end of the transition
period after the parties have developed the list of conformity
assessment bodies (CAB's) found to be equivalent. The provisions of
Sec. Sec. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will
apply only with regard to listed CAB's and only to the extent of any
specifications and limitations contained on the list with regard to a
CAB.
(b) The operational period will apply to quality system evaluation
reports and product evaluation reports generated by CAB's listed in
accordance with this subpart for the evaluations performed in the
respective territories of the parties, except if the parties agree
otherwise.
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