Guidelines for Import and Manufacture of Medical
The Ministry of Health and F.W. under Gazette notification
S.O. 1468 (E) dated 6/10/2005 declared the following
sterile devices to be considered as drugs under Section 3
(b) (iv) of the Act.
Drug Eluting Stents.
Intra Ocular Lenses.
Scalp Vein Set.
It was also
notified vide GSR 627 (E) dated 7/10/2005 that control
over manufacture of these devices would be exercised by
CLAA i.e. DCG(I) under the said Rules.
Ministry of Health and Family Welfare have now approved
the following procedures to be adopted in respect of
licensing of import as well as manufacture of these
Medical Devices in the country.
guidelines shall be effective from 1st March 2006
OF MEDICAL DEVICES
purpose of import of Devices specified above, the
procedure for registration and import licence as
prescribed under the Drugs and Cosmetics Rules shall be
A period of 60 days would be
provided for the importers to make application for import
and registration from the date of publication of these
In case of devices which have
not been imported in the country before the date of
notification no import would be permitted without the
approval of the competent authority.
For the time being and for a
period upto six months, until an application is approved
or rejected, whichever is earlier, the devices which are
currently in use will be permitted to be sold. In case of
stents or drug eluting stents the import will not be
permitted if the applicant has not sold less than One
thousand stents of the particular specification prior to
the date of issue of these guidelines.
Separate committees consisting
of subject experts and representative of DCG(I) office
would be setup for their expert advice for evaluation of
specific categories of devices. The expert committees
would formulate their own benchmarks and procedures for
evaluations and the standards to which such devices should
guidelines regarding following requirements are given at
Registration of Medical
Devices for Import
Master File (Details of Good
Manufacturing Practices employed by the manufacturer to
ensure quality of the device)
Devices containing medicinal
Post Market Surveillance
Undertaking of conformity with
respect to product standards, safety and effectiveness
requirements and quality systems in the country of origin.