Common use of Regulatory Responsibility Clause in Contracts

Regulatory Responsibility. Buyer shall be responsible for all FDA and other applicable international (e.g., MDD, CMDCAS, etc.) regulatory reporting and registration, regulatory submissions, Product performance monitoring, complaint handling, and field service. Buyer shall notify Seller of customer complaints related to the work performed by Seller, and any Medical Device Reports or vigilance reports that are submitted to the FDA or other international regulatory agencies regarding the Products within 10 business days of their notification or submission. Seller agrees to cooperate, support and investigate such matters as requested by Buyer. Seller shall be responsible for maintaining FDA registration for the facility that manufactures the Products.

Regulatory Responsibility. Buyer shall be responsible for all FDA and other applicable international (e.g., MDD, CMDCAS, etc.) regulatory reporting and registration, regulatory submissions, Product performance monitoring, complaint handling, and field serviceservice with respect to the Products. Buyer shall promptly notify Seller of any customer complaints related to the work performed by Seller, and any Medical Device Reports or vigilance reports that are submitted to the FDA or other international regulatory agencies regarding the Products within 10 business days of their notification or submission. Seller agrees to cooperate, support and investigate such matters as requested by Buyer. Seller shall be responsible for maintaining FDA registration for the facility that manufactures the Products.

Regulatory Responsibility. Buyer shall be responsible for all FDA and other applicable international (e.g., MDD, CMDCAS, etc.) regulatory reporting and registration, regulatory submissions, Product performance monitoring, complaint handling, and field service. Buyer shall notify Seller of customer complaints related to the work performed by the Seller, and any Medical Device Reports or vigilance reports that are submitted to the FDA or other international regulatory agencies regarding the Products within 10 business days of their notification or submission. Seller agrees to cooperate, support and investigate such matters as requested by Buyer. Seller shall be responsible for maintaining FDA registration for the facility that manufactures the Products.