质量体系评价报告的传递

时间: 2008-07-31


2008-04-01

21 CFR 26.43

Transmission of quality system evaluation reports.

2009-06-09

 
  [Code of Federal Regulations][Title 21, Volume 1][Revised as of April 1, 2008]From the U.S. Government Printing Office via GPO Access[CITE: 21CFR26.43][Page 257] 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 REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, Subpart B_Specific Sector Provisions for Medical Devices Sec. 26.43 Transmission of quality system evaluation reports. Quality system evaluation reports covered by Sec. 26.41 concerning products covered by this subpart shall be transmitted to the importing party within 60-calendar days of a request by the importing party. Should a new inspection be requested, the time period shall be extended by an additional 30-calendar days. A party may request a new inspection, for cause, identified to the other party. If the exporting party cannot perform an inspection within a specified period of time, the importing party may perform an inspection on its own.