Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design v ...

POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be designed by the sponsor to answer general question as follows: i. Does the new drug provide a clinical benefit? ii. Is the associated risk outweighing the benefits for the proposed indication? iii. Can the product be manufactured ensuring quality and batch to batch consistency? 2. There should be a system that b ...

(xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for the administration or exchange of energy to or with a human body. (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or exchange of energy may ...