2023-06-08T04:32:48
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;
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 30 of 248
(vi) the licence holder shall, on being informed by the Central Licensing
Authority or State Licensing Authority, as the case may be, that any part
of any lot of the medical device has been found not conforming with the
provisions specified under the Act and these rules, and on being directed
so to do by such licensing authority, withdraw the remainder of that lot from sale and, so far as may, in the particular circumstances of the case, be practicable, recall the issues already made from that lot;
(vii) the licence holder shall maintain an audit or inspection book in Form MD-11 to enable the Notified Body or Medical Device Officer to record his observations and non-conformity, if any;
(viii) the licence holder shall maintain at least one unit of sample from
each batch of invasive medical device and in vitro diagnostic medical
device manufactured for reference purpose for a period of one hundred
and eighty days after the date of expiry of such batch;
(ix) the licence holder shall maintain records of manufacturing and sales
which shall be open to inspection by a Medical Device Officer;
(x) the medical device, when offered for sale, shall be accompanied by
either its package insert or user manual, wherever applicable;
(xi) the manufacturing or testing activity of medical device shall be undertaken only under the direction and supervision of the competent technical staff;
(xii) if the manufacturer has stopped manufacturing activity or closed the manufacturing site for a period of thirty days or more, the same shall be intimated to the Central Licensing Authority or the State Licensing Authority, as the case may be.
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