Subpart B. Subpart B—Specific Sector Provisions for Medical Devices
- § 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.