1.
Proprietary/Brand name.
2.
Brief description of the
device.
3.
Category of device.
4.
Intended use and method
of use.
5.
Medicals specialty in
which the device is used.
6.
Qualitative and
quantitative particulars of the constituents.
7.
Brief description of the
method of the manufacture and specification of the materials used.
8.
Contraindications,
warnings, precautions potential adverse events and alternate therapy, wherever
applicable.
9.
List of accessories and
other devices or equipment to be used in combination with the device. Other
descriptive information, including accessories packaged with the product.
10.
Variations in shape,
style or size of the device, if applicable.
11.
Labeling details
conforming to Drugs and Cosmetics Rules, 1945.
12.
Physician manual and
promotional literature (Literature insert) in English.
13.
Packaging description
including pack sizes.
14.
Recommended storage
conditions.
15.
Summary indications of
any reported problems.
16.
Details of standards to
which the device conform alongwith the copy of the standard.
(C) Regulatory Status
1.
Approval of the product from any other regulatory agency (Separate evidence for
the approval from the each agency)
(i)
US FDA
clearance/approval.
(ii)
EU medical device
directive (CE Certificate).
(iii)
Australia/Canada/Japan
approval.
(iv)
Approval in any other
country.
1.
Copy of ISO/EN
Certification if any for the manufacturing facility.
2.
List of countries where
the device is being sold.
3.
List of countries where
device is withdrawn from sale with reasons,
if any.
(D)
Master File (Details of Good Manufacturing Practices employed by the
manufacturer to ensure quality of the device)
1.
Component/Material used.
2.
Device Master File.
3.
Manufacturing
process/Flow Chart.
4.
Quality Assurance
procedures/process controls.
5.
Final product testing or
design inputs/outputs verification, if applicable.
6.
Functionality Test
protocol and report, if applicable.
7.
Risk Assessment as per
ISO 14971.
8.
Sterilization process
and validation/verification.
9.
Stability data or
statement of established stability of material used as applicable.
10.
Shelf life of the
device.
11.
Biocompatibility and
Toxicological data, wherever applicable.
12.
Device GMP Certificate.
(E) Devices containing
medicinal product
1.
If device incorporates a
medicinal product, which is liable to act upon the body with action ancillary to
that of the device, data on the safety, quality and usefulness of the medicinal
substance used.
2.
Data on compatibility
with medicinal products, if device intended to deliver medicinal products.
3.
Clinical data and
published articles, if any.
4.
Batch Release
Certificate for products incorporating any medicinal substance or substances of
animal origin.
5.
For devices not approve
for marketing in the country of origin, the applicant shall submit reports of
clinical trials, details of sales, certificates of satisfactory use from the
medical specialists about the use of the device and details of product
complaints, if any.
(Medical Devices with
prior approval from any of the recognized regulatory authorities will be
subjected to an abridged evaluation and only a summary of all the studies and
information described above is to be submitted)
(F) Post Market
Surveillance
1.
Procedures for
distribution of records.
2.
Complaint handling.
3.
Adverse incident
reporting.
4.
Procedure for product
recall.
(G)
Undertaking of conformity with respect to product standards, safety and
effectiveness requirements and quality systems in the country of origin.
5.
The Registration
Certificate shall be issued in Form 41 of the said Rules.
6.
The application for
import licence shall be made in Form 8 alongwith a fee
of Rs. 1000/- in the Form and manner prescribed under the
Drugs and Cosmetics Rules.
MANUFACTURE OF MEDICAL DEVICES IN THE COUNTRY
1.
Application for the
grant of licence for manufacture of these notified sterile Devices in the
country shall be made in Form 27 to the State Licensing Authority, accompanied
by the requisite fee in the Form and manner as prescribed in the said Rules
alongwith a copy to the office of DCG(I).
2.
A period of 60 days
would be provided for making the application for manufacture from the date of
publication of these guidelines.
3.
In case of devices
belonging to above said categories which have not been manufactured in the
country before the date of notification, no manufacture would be permitted hence
forth without the approval of the competent authority as per norms prescribed.
4.
The applicant shall
provide the following information alongwith the application for consideration of
the licensing authority.
Manufacturing Details:
(a)
Complete details about
the names, addresses of the directors of the company and addresses of the
manufacturing premises and registered offices of the manufacturer.
(b)
A brief project
highlight indicating the plans of the company, devices to be manufacture, their
viability and other relevant profiles.
(c)
Copy of the Site Master
File.
(d)
A brief description of
the manufacturing process of the devices to be manufactured.
(e)
Details of the standards
followed by the company for Good Manufacturing Practices and product evaluation.
(f)
Name, qualification and
experience of technical staff under whose supervision the devices will be
manufactured.
(g)
Copies of ISO or any
other certifications, if any, obtained by the firm for its manufacturing
facility.
Product Details:-
A.
Proprietary/Brand name.
B.
Brief description of the
device.
C.
Category of device.
D.
Intended use and method
of use.
E.
Medical specialty in
which the device is used.
F.
Qualitative and
quantitative particulars of the constituents.
G.
Specifications of the
materials used.
H.
Testing facilities
available in the manufacturing premises for testing.
I.
Standards and procedures
for testing the device.
J.
Contraindications,
warnings, precautions potential adverse events and alternate therapy, wherever
applicable.
K.
List of accessories and
other devices or equipment to be used in combination with the device. Other
descriptive information, including accessories packaged with the product.
L.
Information on stability
of the product.
M.
Details of clinical
trials, (wherever applicable) carried out on the product.
N.
Variations in shape,
style or size of the device, if applicable.
O.
Labeling details
conforming to Drugs and Cosmetics Rules, 1945.
P.
Physician manual and
promotional literature (Literature insert) in English.(if any)
Q.
Packaging description
including pack sizes.
R.
Recommended storage
conditions.
S.
Summary indications of
any reported problems.
5.
For the purpose of
evaluation of Medical Devices which are new or do not have any benchmark
certification, Expert Committees shall be setup to examine in detail the
information provided by the applicant for the assessment of the device.
6.
The committee after
completing their assessment forward the opinion regarding suitability of the
device to the competent authority for the purpose of grant of permission for
placing the device in the market.
7.
The State Licensing
Authority after Joint Inspection and verification would forward the licence to
CLAA for approval.
8.
The licence shall be
issued in Form 28 of the said Rules after due approval of CLAA.
SALE OF MEDICAL DEVICES IN THE COUNTRY
The importers, stokists
and retail sellers of Medical Devices shall obtain appropriate sale licences
from the State Licensing Authorities for these Medical Devices within a period
of 3 months form the issue of these guidelines.
