SUBPART B—Specific Sector Provisions for Medical Devices (§26.31 to §26.50)
- 26.31—Purpose.
- 26.32—Scope.
- 26.33—Product coverage.
- 26.34—Regulatory authorities.
- 26.35—Length and purpose of transition period.
- 26.36—Listing of CAB's.
- 26.37—Confidence building activities.
- 26.38—Other transition period activities.
- 26.39—Equivalence assessment.
- 26.40—Start of the operational period.
- 26.41—Exchange and endorsement of quality system evaluation reports.
- 26.42—Exchange and endorsement of product evaluation reports.
- 26.43—Transmission of quality system evaluation reports.
- 26.44—Transmission of product evaluation reports.
- 26.45—Monitoring continued equivalence.
- 26.46—Listing of additional CAB's.
- 26.47—Role and composition of the Joint Sectoral Committee.
- 26.48—Harmonization.
- 26.49—Regulatory cooperation.
- 26.50—Alert system and exchange of postmarket vigilance reports.