Conditions for manufacturing licence or loan licence After grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following conditions, namely:— (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or State Licensing Authority, as the case may be; (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder; (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or rejection within forty-five days and in case where no communication is received within the stipulated time from such Authority, such change shall be deemed to have been approved; (iv) the licence holder shall inform any minor change as specified in the Sixth Schedule to the State Licensing Authority or Central Licensing Authority, as the case may be, within a period of thirty days after such minor change take place; (v) the licence holder shall carry out test of each batch of product manufactured prior to its release for compliance with specifications either in his own laboratory or in any other laboratory registered under sub-rule (3) of rule 83;