If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process. 7.5.1.2.2 Installation activities If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device o ...

INDUSTRY AND CDSCO COMMUNICATION 1. CDSCO needs to work collaboratively and cooperatively with Industry, academia and others to promote new drug development and to expedite the review process and making the safe and effective new drugs available at the earliest to address various disease burden in the country. 2. CDSCO should be dedicated to ensure that all persons involved in the new drug develop ...

Design and development review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements— (a) to evaluate the ability of the results of design and development to meet requirements; and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with th ...