2023-05-09T04:41:53
MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR
DISTRIBUTION
20. Application for manufacture for sale or for distribution of Class A
12
[(other than non-sterile and non-measuring)] or Class B medical device
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 24 of 248
(1) Any person who intends to manufacture a Class A 13[(other than
non-sterile and non-measuring)] or Class B medical device including in intro
diagnostic medical device shall make an application for grant of licence or
loan licence to manufacture for sale or for distribution to the State Licensing
Authority.
(2) The application under sub-rule (1) shall be made through an
identified online portal of the Ministry of Health and Family Welfare in the
Central Government in Form MD-3 for licence or in Form MD-4 for loan
licence accompanied with a fee, as specified in the Second Schedule along
with respective documents as specified in Part II of the Fourth Schedule.
(3) The application made under sub-rule (1), shall, amongst others, be
accompanied with an undertaking to the effect that the requirements of
Quality Management System as specified in the Fifth Schedule have been
complied with.
(4) The State Licensing Authority shall, after scrutiny of documents and
on being satisfied that the requirements of these rules have been complied
with, grant a licence to manufacture Class A 14[(other than non-sterile and
non-measuring)] medical devices in Form MD-5 or loan licence in Form MD6, as the case may be, or if not satisfied, reject the application for reasons to
be recorded in writing, within forty-five days from the date, the application is
made under sub-rule (1):
PROVIDED that, —
(i) no audit of the manufacturing site shall be necessary prior to grant of
licence or loan licence to manufacture for sale or for distribution of Class
A 15[(other than non-sterile and non-measuring)] medical device; and
(ii) the required audit of such manufacturing site by the registered
Notified Body in the manner as specified in the Third Schedule shall be
carried out within one hundred and twenty days from the date on which
the licence was granted by the State Licensing Authority.
(5) Manufacturing site of the applicant, in respect of Class B device,
shall conform to the requirements of Quality Management System as
specified under the Fifth Schedule and applicable standards as specified under
Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 25 of 248
these rules and such conformance shall be verified through an audit by a
Notified Body as referred under rule 13 before grant of licence.
(6) In case of application for grant of licence or loan licence to
manufacture for sale or for distribution of Class B medical devices, —
(i) the audit of the manufacturing site shall be carried out within ninety'
days from the date of application by the registered Notified Body in the
manner specified in the Third Schedule;
(ii) the Notified Body shall furnish its report to the State Licensing
Authority within thirty days of the completion of audit;
(iii) the State Licensing Authority shall, after scrutiny of documents, audit
report as referred to in clause (ii) and on being satisfied that the
requirements of these rules have been complied with, grant a licence to
manufacture Class B medical devices in Form MD-5 or loan licence in
Form MD-6, as the case may be, or if not satisfied, reject the application
for reasons to be recorded in writing, within a period of twenty days from
the date of receipt of the report of audit by the Notified Body.
(7) If the application for grant of licence or loan licence to manufacture
for sale or for distribution is rejected under sub-rule (4) or sub-rule (6), the
aggrieved person may file an appeal before the State Government within
forty-five days from the date of receipt of such rejection, which may, after
such enquiry and after giving an opportunity of being heard to the appellant,
be disposed of within a period of sixty days.
(8) Where the Central Licensing Authority or the State Licensing
Authority has reason to believe or it has been alleged or suspected that the
medical device does not conform to the standards of quality, or the provisions
of the Fifth Schedule are not complied with, the State Licensing Authority, in
case of Class A 16[(other than non-sterile and non-measuring)] or Class B
medical device, or the Central Licensing Authority, in case of any Class of
medical device, may direct a team of officers referred to in rule 23 to cause
inspection of licensed manufacturing site.
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