Import formalities for medical equipments
MEDICAL EQUIPMENTS IMPORT FORMALITIES
Description also available in video format (attached
below), for better experience use your desktop.
Introduction
·
The Ministry of Health and Family Welfare
under the gazette notification S.O 1468 (E) declared these sterile equipment's to
be considered under Section 3 (b) (iv) of the Act
o
Cardiac Stents
o
Drug Eluting Stents
o
Catheters
o
Intra Ocular Lenses
o I.V Cannula
o
Bone Cements
o
Heart Valves
o
Scalp Vein Set
o
Orthopedic Implants
o
Internal Prosthetic replacements
·
The
MoHFW approved the below mentioned formalities for the import of medical Equipment’s
in India
Import
of Medical Equipment’s
·
A period of 60days would be provided to the
importer to make application for the import and registration
·
If any equipment have not been imported in
the country before ever will not be permitted without the permission of the
competent authority
·
Until an application is approved or rejected,
the Equipment’s 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 sold less 1000 stents of the
particular specifications
·
Separate committees having experts of their
field advice for the evaluation of specific equipment.
·
The committee would formulate their own
standards, benchmarks and procedures for the evaluation of importing equipments
Registration
of Medical Equipment's for Import
·
Application for Registration certificate in
respect to the Equipment’s meant for import into India is required to be made
by the importer in form 40
·
A fee of 1,32,000 shall be paid for the
registration of a single medical equipment
·
The fees shall be paid through challan as
prescribed
·
The information and undertakings required to
be furnished to suit the requirement of equipment's and includes the following
details
o
Applicant Details
§ Applicant company name, contact number and address
§ Name & address of the foreign supplier
§ Name & address of the local authorized representative
§ Copy of the Plant Master File
§ Name and address of the importer
§ Local manufacturer, if any processing is being done in
the country
o
Product Information
§ Proprietary/Brand name
§ Brief description & Category of the Equipment’s
§ Intended use and method of use
§ Medicals specialty in which the Equipment is used
§ Brief description of the methods of manufacturing
§ List of accessories & Packaging description
§ Recommended storage conditions
o
Regulatory Status
§ Approval of the product from other regulatory agencies
like
· USFDA
· EU medical Equipment’s
· Approval in any other country
§ Copy of ISO
§ List of countries where the Equipment is being sold
§ List of countries where equipment is withdrawn from sale
with reason
o
Master File (details
of GMP used by the manufacturer)
§ Raw material & Components used
§ Manufacturing process
§ Quality assurance and process control
§ Risk assessment as per ISO 14971
§ Shelf life and GMP certificate
o
Post Market Surveillance
§ Procedure for the distribution of records
§ Complaint handling
§ Adverse incident reporting
§ Procedure for product recall
Video
Description
·
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