[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: 21CFR26.38]
[Page 255]
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. 26.38 Other transition period activities.
(a) During the transition period, the parties will jointly determine
the necessary information which must be present in quality system and
product evaluation reports.
(b) The parties will jointly develop a notification and alert system
to be used in case of defects, recalls, and other problems concerning
product quality that could necessitate additional actions (e.g.,
inspections by the parties of the importing country) or suspension of
the distribution of the product.
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