Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Guidance Document
(Medical Devices Division)
: Guidance document on
Title
: CDSCO/MD/GD/CLAA/01/00
Date
: 31.10.2012
Table of Contents
Sr.No.
A.
Preface
B.
Content
Page No.
3-4
5-6
5
Authorization Letter
Form 27
Challan (Fees)
Constitution Details
Specific Requirements
10
11
12
13
14
15
Declaration of Conformity
6
7-43
Annexure I
8-13
Annexure II
14-15
Annexure III
16-16
Annexure IV
17-25
Annexure V
Specific Requirements
26-26
Annexure VI
27-33
Annexure VII
34-40
Page | 2
A. Preface
In India import, manufacture, sale and distribution of Medical
devices is regulated under Drugs and Cosmetics Act, 1940; and
Rules, 1945. At present following notified Medical Devices are
regulated under the said Act.
S. No.
1.
2.
3.
4
Name of Device
Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
In Vitro Diagnostic Devices for HIV,
HBsAg and HCV.
5
Cardiac Stents.
6.
Drug Eluting Stents.
7.
Catheters.
8.
Intra Ocular Lenses.
9.
I.V. Cannulae.
10.
Bone Cements.
11.
Heart Valves.
12.
Scalp Vein Set.
13.
Orthopedic Implants.
14.
Internal Prosthetic Replacements.
Manufacture for sale of Disposable Hypodermic Syringes,
Disposable Hypodermic Needles, Disposable Perfusion sets and Invitro Diagnostic Devices are regulated by the concerned State Drug
Licensing Authority only.
However this document is applicable for following Devices only
S. No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Name of Device
Cardiac Stents.
Drug Eluting Stents.
Catheters.
Intra Ocular Lenses.
I.V. Cannulae.
Bone Cements.
Heart Valves.
Scalp Vein Set.
Orthopedic Implants.
Internal Prosthetic Replacements.
Page | 3
Page | 4
The concerned State Drugs Licensing Authority, Address of all SLA are
placed at Annexure-I.
ii.
iii.
The Drugs Controller General of India CDSCO (HQ), FDA Bhawan, Near Bal
Bhawan, ITO, Kotla Road, New Delhi-110002.
accompanied by the requisite fee in the form and manner as prescribed in the Drugs
& Cosmetics Rules.
The following documents are required to be submitted in the following manner and
order for grant of licence in form-28 for Manufacture of Medical Devices in India: 1. Covering Letter The covering letter is an important part of the application
and should clearly specify the intent of the application. The list of documents
that are being submitted (Index with page number) as well as any other
important and relevant information may be provided in the covering letter.
The covering letter should be duly signed and stamped by the authorized
signatory, indicating the name & designation of the authorized signatory.
2. An Authorization letter in original issued by the Director/Company
Secretary/Partner of the Indian Agent firm revealing the name & designation
of the person authorized to sign legal documents such as Form-27 on behalf
of the firm should be submitted at the time of submission of the application for
grant/Renewal of licence. It should have validity period as per companys
policies. Duly attested photocopies of the Authorization letter may be
submitted at the time of submission of subsequent applications.
3. A duly filled Form 27 as per the Performa prescribed in the Drugs &
Cosmetics Rules, signed & stamped by the Indian Agent along with name &
designation. Form 27 Performa is enclosed at Annexure - III.
4. The requisite fee as prescribed in the Drugs & Cosmetics Act & Rules viz.
Licence fees of Rs.6000/- and an Inspection fees of Rs. 1500/- (Total Rs.
7500/- for 10 items for each category of Device) and additional fees at the
rate of Rs.300/- for a each additional item of Device.
5. Constitution Details Documents relating to constitution of firm viz.
partnership-deed, memorandum and article of association etc.
Page | 5
In case of New Devices/not yet approved in India, the applicant has to submit a
copy of necessary permission/NOC from the Drugs Controller General (I) along
with the application.
Page | 6
C. Annexures
Annexure I
Annexure II
Annexure III
Annexure IV
Annexure V
Specific Requirements
Annexure VI
Annexure VII
Page | 7
ANNEXURE-I
State
Andhra
Pradesh
Arunachal
Pradesh
Assam
Bihar
Chhattisgarh
Delhi
Goa
Address
Tel. Office.
Fax
23814119,
0944062731, 04023713563
23814360.
23415006
(0360)2244248
04023814360
0361-2265276
2261630
2244105
0612-221110 ,
09430218184
2224608
(0771) 2235226
2221025
2235226
23967511 ,
22393707
22393701
22393706
23392018,
22393704
(0832)2224639(Dire
ct)
2220245/2430948
(0832)222
4639
Page | 8
Gujarat
Haryana
Commissioner, Food
and Drug Control
Admn., Gujarat,Block-8,
Dr. Jivraj Mehta
Bhavan,1st Floor,
Gandhi Nagar-382010
Drugs Controller of
Haryana, Food and Drugs
(079)23253400
23253399,
09978405054
23253400
23252417
(0172)2551081
2551692
Administration, Haryana
SCO-94, Sector-5,
Panchkula, Haryana
10
Himachal
Pradesh
11
Jharkhand
12
Jammu &
Kashmir
13
Karnataka
14
Kerala
15
Madhya
Pradesh
DRUGS CONTROLL
ADMINISTRATION,
NEAR BUS STAND,
SAI ROAD, BADDI,
DISTT. SOLAN (H.P.)173205
Drugs Controller and
Licensing Authority,
Jharkhand, Dte. of
Health Services,
Jagannathpur High
School Building, Sector
3, Dhurwan, RANCHI834004
Drugs Controller,
J&K,Drug and Food
Control Admn.Patoli
Magotrian, JAMMU
TAWI-180001
Drugs Controller, Drug
Control Department, PB
No.5377,Palace
Road,BANGALORE560001
Drugs Controller and
Licensing Authority,
Kerala, Public Health
Laboratory Campur,
Red Cross
Road,Thiruvananthapur
am-695035
Drugs Controller, Food
& Drugs
Administration,Madhya
Pradesh,Idgah Hill,
BHOPAL 462001
0177-2621842
221107
06512260361
(0191)2538527,
2597445,
(080)22262846,
22282789,
22256386,
9449818892
22286492
(0471)2473256,
09447010210,0944
6048210
2473256
(0755)2665385
2666058
2665385
Page | 9
16
Maharashtra
Jt Commissioner,Food
and Drugs
Admn.,Maharashtra,341
, Bandra Kulra
Complex,Opp. RBI
Building, Bandra (East)
Mumbai-400 051
Office of the Joint
Commissioner
(Kokan Division.)
Food and Drug
Administration, M.S.,
E.S.I.S. Hospital Bldg.,
4th floor, Road No.33,
Wagale Estate,
THANE-400604.
Office of the Joint
Commissioner
(Pune Division.)
Food and Drug
Administration, M.S.,
Lucky Bldg., 791/92,
New Guruwar Peth,
PUNE-411028
Office of the Joint
Commissioner
(Nashik Division.)
Food and Drug
Administration M.S.
Hall No 21 and 23,
Udhyog Bhavan,
Tryambakeshwar Road,
NASHIK-422003.
Office of the Joint
Commissioner
(Nagpur Division.)
Food and Drug
Administration, M.S.,
Limbana Compound, 20
Mount Rd., Sadar,
NAGPUR-440 001
(022)26590548,
26591463
26591959
+ 91 022 25811988/2582124
5
+ 91 022
- 25823189
+ 91 020 24470276
+ 91 020
- 24477555
+ 91
0253 2351204
+ 91 0712 2564347/2562204
+ 91
0712 2555120
Page | 10
17
Manipur
18
Meghalaya
19
Mizoram
20
Nagaland
21
Orissa
+ 91 0721 2663273/2665892/
+ 91
07212663273
2665891
+ 91 0240 2331268/2346810
+ 91
0240 2331268
0385-2414964
03852414964
(0364)2225709
2228493
0389-2323452
2320169
(0370)2222626
(0674) 2300494
2243887
2300494
Page | 11
22
Punjab
Drugs Controller,
Punjab,Sector 34 A,
CHANDIGARH-160016.
(0172)2603803
2609142
23
Rajasthan
0141-2221670
2337284
24
Sikkim
25
26
27
28
29
30
Dy.Drugs Controller,Dpt.
Of Health &
F.W.,Sikkim, Gangtok737101
Tamilnadu
Drugs Controller
Tamilnadu, 259/261,
Anna Salai, Chennai
600006
Tripura
Dy.Drugs Controller and
Licensing Authority,
Tripura, Aushadh
Niyantran Bhawan,
Pt.Nehru Office
Complex,PO Kunjaben,AGARTALA
799006
Uttar Pradesh Drugs Controller of
UP,Swasthya Sewa
Mahanideshalaya,
Swasthya Bhawan,
Aushadhi
Kaksha,LUCKNOW226006.
Uttrakhand
Drugs Controller ,
Directorate of Medical
Health, Dada Lokhond ,
SahashtraDhara Road,
Dehradun
West Bangal Director, Drugs Control
West Bengal, P-16,
India Exchange Place
Extn. Cit Building ,
KOLKATA -700073
Andaman &
Dte. of Health Services,
Nicobar
A&N Island, PORT
BLAIR 744104
(044) 24321830
,9710142019, 04424311830
04424321830
(0381) 2325868
2325868
0522-2221115
05222621115
09411014217
(033) 22252215,
24778710,
9831261582,
09433038710
(03192)233331
232910
232910
Page | 12
31
32
33
34
35
Chandigarh
admn.
(0172) 780781
27500255
(0260)2642940
2642120
26429061
(0413) 2353647
(04896)62316
62817
(0260) 2230470
2230847
2230570
Page | 13
ANNEXURE-II
LIST OF ZONAL AND SUB-ZONAL OFFICES OF CENTRAL DRUGS
STANDARD CONTROL ORGANISATION (CDSCO)
Sr.
No
1
Zone
Address
East Zone
West Zone
Phone
No./
Fax No
Phone No.033
22870513
Fax : 033 22813806
Phone No.91-2223002279,
23002215,
23092971.
Name of States
Andaman and
Nicobar Island,
Arunachal Pradesh,
Assam, Bihar,
Jharkhand, Manipur,
Meghalaya,
Mizoram, Nagaland,
Orissa, Sikkim,
Tripura & West
Bengal
Chhattisgarh, Goa,
Daman & Diu,
Madhya Pradesh
and Maharashtra
Fax: 91 (22)
23002271
Tele Fax No.
07922865244
Gujarat
Haryana, Himachal
Pradesh, Jammu &
Kashmir, Punjab,
Rajasthan,
Uttaranchal, Uttar
Pradesh, N.C.T. of
Delhi & Union
Territory of
Chandigarh
Fax: 91 -12027101927
Page | 14
Sub-Zonal
Jammu
South Zone
01912593338
Kerala, Pondicherry,
Lakshadweep,
Dadar & Nagar
Haveli and Tamil
Nadu
Tele Fax :
04428213079
Hyderabad Dy. Drug Controller Phone No. Zonal Office (India), CDSCO, Zonal 040
office, CDTL Building, 24008236.
Chest Hospital, S.R.
Nagar, Hyderabad Fax : 040
500 038.
24008270
Sub Zonal, Subzonal OfficePhoneNo.Bangalore
Asstt. Drugs Controller 080(I)
23286492
CDSCO, Sub Zonal
Office, 2nd Floor
Fax : 080Office for the State 22341080
Drugs Controller of
Karnataka
Palace
Road,
Bangalore-560001
Andhra Pradesh
Karnataka
Page | 15
ANNEXURE-III
FORM 27
Application for grant or renewal of a [licence to manufacture for sale or for
distribution] of drugs specified in Schedules C and C (1) [excluding those
specified in Schedule XB and Schedule X]
1.1/ We ........................................................hereby apply for the grant / renewal of a
licence to manufacture on the premises situated at the undermentioned drugs, being
drugs specified in Schedules C and C (1) 2[excluding those specified in Schedule XB
and Schedule X] to the Drugs and Cosmetics Rules, 1945.
Names of drugs...
(each item to be separately specified).
2. The names, qualifications and experience of the expert staff responsible for the
manufacture and testing of the above mentioned drugs.
(a) Name (s) of staff responsible for test....................................
(b) Name (s) of staff responsible for manufacture..........................
3. The premises and plan are ready for inspection______
will be ready for inspection on
4. A fee of rupees....................................................and an inspection fee of rupees
has been credited to Government under the head of
account.
Date.........................................
Signature
Designation..
Page | 16
ANNEXURE IV
Site Master File
NOTE: The manufacturer shall submit the duly signed information pertaining to
Manufacturing premises in the following format. It is expected that the information submitted
in the form of hard copy shall also be submitted in the form of soft copy. The applicant shall
submit a succinct document in the Form of Site Master File containing specific and factual
information about the production and/or control of manufacturing process carried out at
manufacturing premises. It shall contain the following information but not limited to:
Sr.
No
Requirements
Information
GENERAL INFORMATION
Brief information on
the site (including
name and address),
relation to other sites
II
Manufacturing
activities
III
Any other operations This covers both medical device related and non-medical
carried out on the site
device (including medicinal products) related activities.
IV
Name
and
exact 1. Name of company, site address and mailing address (if
address of the site, different from site address)
including
telephone,
fax numbers, web site 2. Telephone, fax nos. and email address of contact person
URL
and
e-mail
address
Type
of
medical
devices handled on the
site and information
about specifically toxic
or
hazardous
substances
handled,
mentioning the way
they are handled and
precautions taken
Page | 17
VI
Short description of 1. Provide a map indicating the location of the site(s) and the
the site (size, location surrounding area. Mark the site(s).
and
immediate
environment and other 2. Other activities on the site.
activities on the site)
VII
Number of employees
engaged in Production,
Quality
Control,
warehousing,
and
distribution
VIII
IX
Use
of
outside
scientific, analytical or
other
technical
assistance in relation
to
the
design,
manufacture
and
testing
Area of Operation
1.
2.
3.
4.
5.
6.
No of
Permanent/regular
employees
No of
Contractual
employees
Production
Quality Control
Warehousing
Storage
Distribution
Technical
&
Engineering Support
Services
Total of the above
Devices
details State name of the devices along with the name of the
registered with foreign countries where the device is approved/registered.
countries
PERSONNEL
Organisation
chart Organogram listing key personnel (Quality Assurance,
showing
the Production, and Quality Control) has to be constructed.
arrangements for key Record senior managers and supervisors only.
personnel
II
Qualifications,
1.
Brief details of qualifications and years of relevant
experience
and experience since qualifying.
responsibilities of key
2. Job descriptions for the key personnel
personnel
III
Outline
of
arrangements for basic
and in-service training
and how records are
maintained
IV
Health
requirements Give brief details of the following:
for personnel engaged
1. Who is responsible for checking health of employees?
in production
2. Is there a pre-employment medical examination?
3. Are employees routinely checked from time to time
depending on the nature of their work?
4. Is there a system for reporting sickness or contact with
sick people before working in a critical area?
5. Is there a system of reporting back after illness?
6. Are those who work in clean areas (Grade A-D) subject
to additional monitoring?
Personnel
hygiene Give brief details of the following:
requirements,
1. Are there suitable washing, changing and rest areas?
including clothing
2. Is the clothing suitable for the activity undertaken? Briefly
describe the clothing
3. Are there clear instructions on how protective clothing
should be used and when it should be changed? Is inhouse or external laundry used?
Page | 19
II
III
Brief description of
ventilation
systems.
More details should be
given for critical areas
with potential risks of
airborne contamination
(including
schematic
drawings
of
the
systems).
Classification of the
rooms used for the
manufacture of sterile
products should be
mentioned
Brief description of
water systems
(schematic drawings of
the systems are
IV
desirable) including
sanitation
VI
D
I
II
III
Qualification
and Following points should be addressed:
calibration, including
1. Briefly describe the company's general policy and
the recording system.
protocols for qualification and validation (prospective
Arrangements
for
and retrospective).
computerized systems
2. Is there regular revalidation of critical equipment?
validation.
3. An outline of process validation may be given here or
cross-referenced to Production
4. Describe the system for the release for sale or supply
of development and validation batches.
5. What are the arrangements for computer validation,
including software validation?
6. Describe equipment calibration policy and records
kept
E
I
SANITATION
Availability of written Cleaning procedures for the manufacturing
areas and
specifications
and equipments should include:
procedures
for
1. Are there written procedures for cleaning and
cleaning
the
specifications for cleaning agents and their
manufacturing
areas
concentration for the method of cleaning and the
and equipments
frequency?
2. Are cleaning agents changed from time to time?
3. Have the cleaning procedures been validated and what
was the method of evaluating the effectiveness of
cleaning?
4. Are cleaning methods monitored routinely by chemical
and/or microbiological methods?
5. What are the cleaning methods (and their frequency)
for the water system, air handling system and dust
extraction system?
F
I
PRODUCTION
Brief description of Describe the production operations using flow charts. The
production operations following points should be addressed:
using,
wherever
1. Describe the operations capable of being carried out
possible, flow sheets
at the site with the existing facilities and specify the
and charts specifying
types of medical devices
important parameters
2. When only packaging is undertaken, give a brief
description only, e.g. labelling, filling etc. and the
nature of containers used
3. When only packaging is undertaken, give a brief
description only, e.g. labelling, details of packaging
materials used etc.
II
III
IV
G
I
QUALITY CONTROLS
Description
of
the The following points should be addressed:
Quality Control system
1. Describe the activities of the QC system e.g.
and of the activities of
specifications, test methods, analytical testing,
the Quality Control
packaging, component testing, biological and
Department.
microbiological testing and other quality related data
Procedures for the
collection.
release of
finished
2. Outline the involvement in the arrangements for the
preparation, revision and distribution of documents in
products
particular those for specification test methods, batch
documentation and release criteria.
STORAGE
Policy on the storage The following points should be addressed:
of medical device
1. How are the medical devices stored e.g. pallet racking?
2. Describe any special storage or handling conditions such
as cold chain management.
H
I
E
I
DOCUMENTATION
Arrangements for the
preparation,
revision
and distribution
of
necessary
documentation,
including storage of
master documents
II
G
I
SELF INSPECTION
Short Description of Following points should be included:
the
internal
audit
1. Describe how the internal audit system verifies that those
system
activities that have a bearing on medical device quality
comply with the planned arrangement.
2. Are there documented procedures for the internal audit
system and for the follow-up actions?
3. Are the results of the internal audit documented, brought to
the attention of the personnel having responsibility for the
area and activities inspected?
Page | 24
4. Does the system ensure that those responsible for the area
or activity take timely corrective action on the deficiencies
found?
H
CONTRACT ACTIVITIES
NOTE:
1. Any information which is not relevant may be stated as Not Applicable in the relevant
Sections/Columns of the above format, and reasons for non-applicability should be
provided.
2. The above information should be submitted in bounded form (like spiral binding or
hard binding).
Page | 25
ANNEXURE V
SPECIFIC ENVIRONMENTAL REQUIREMENTS
1 Moulding, Assembly and Packing area ;( HVAC)
1. The Plastic or Rubber based components May be moulded/extruded in positive
pressurized, ventilated area complying to a Clean Zone as per ISO 14644-1 of at
least Class 9 and subsequently assembled/processed and packed in Clean Room as
per ISO 14644-1 of at least Class 7(Grade-C) (at rest condition).
2. Component of Orthopaedic Implants may be initially Prepared and Processed
(cutting, lathing, etc.) in a well ventilated area. Polishing, cleaning and packing of
Orthopaedic Implants (Non Sterile-to be sterilised in the Hospital) may be done in
Clean Zone as per ISO 14644-1 of at least Class 8(Grade-D). While polishing and
cleaning of Orthopaedic Implants (to be Sterilized in the premises) may be done in
Clean Zone as per ISO 14644-1 of at least class 7 (at rest condition)(Grade-C) and
primary packing should be carried out under Laminar Air Flow work station with
Grade C background.
3. For high risk devices like cardiac stents, bone cements, Internal Prosthetic
Replacements, Heart Valve and Intra Ocular Lenses, and packing should be done
under class 5(Grade-A) with a background of class 7.
Name
of Type of Operation
Device
Cardiac
Packing, Coating, Crimping
stent/Drug
Washing, Ultrasonic cleaning, Annealing
Eluting Stent
Grade
ISO Class
A
C
D
A
C
D
A
C
D
A
5
7
8
5
7
8
5
7
8
5
Product preparation
Component Preparation
C
7
D
8
Ventilated area 9
Valve Packing
Ultrasonic cleaning, visual inspection
Frame, Disc Processing
Intra
Ocular Packing and sealing
Lenses
Cleaning, Inspection, Power Checking
Tumble polishing, Lathe Cutting
Bone Cements
Final product filling
2. Testing Facilities;
1. The licensee shall provide testing facilities for requisite tests carrying out Chemical
and Physico-Chemical testing of medical devices and of raw materials used in its
own premises: Provided that the Licensing Authority may permit the licensee to carry
out microbiological/sterility testing [wherever applicable] from an external approved
public testing laboratory, at the initial stage.
Page | 26
ANNEXURE-VI
Device Master File
Note: The manufacturer shall submit the duly signed information pertaining to Medical
Device in the following format. It is expected that the information submitted in the form of
hard copy shall also be submitted in the form of soft copy.
The dossier shall have an index listing the details of the documents produced as requested
hereunder and shall reflect the page numbers.
of
b. If the device contains any of the following then descriptive information on the
following need to be provided.
1. Animal or human cells tissues and/or derivatives thereof, rendered nonviable (e.g. Porcine Heart Valves)
2. Cells, tissues and/or derivatives of microbial recombinant origin (e.g.
Dermal fillers based on Hyaluronic acid derived from bacterial
fermentation process)
3. Irradiating components, ionising or non ionising
Page | 27
3.0 LABELLING
The dossier should typically contain a complete set of labelling associated with the
device as per the requirements of Labelling. Information on labelling should include the
following:
Original labels of the device, including accessories if any, and its packaging
configuration;
Instructions for use (Prescribers manual)
Product broacher; and
Promotional material.
The label should comply with provisions of Drugs & Cosmetics Rules
Identity
of the
Device
Relevant
Yes/No
Specification/standard
Sub-clause/reference
Complies
Yes/No
Document
Reference
Justification
and/or
comments
engineering tests;
laboratory tests;
simulated use testing;
any animal tests for demonstrating feasibility or proof of concept of the
finished device;
e) any published literature regarding the device or substantially similar
devices.Such summary information may include:
i. declaration/certificate of conformity to a recognised standard(s)
and summary of the data if no acceptance criteria are specified in
the standard;
ii. declaration/certificate of conformity to a published standard(s) that
has not been recognised, supported by a rationale for its use, and
summary of the data if no acceptance criteria are specified in the
standard;
Page | 30
7.2 Biocompatibility
The dossier should contain a list of all materials in direct or indirect contact with the
patient or user.
Where biocompatibility testing has been undertaken (as per recognized standards e.g.
ISO 10993) to characterize the physical, chemical, toxicological and biological response
of a material, detailed information should be included on the tests conducted, standards
applied, test protocols, the analysis of data and the summary of results. At a minimum,
tests should be conducted on samples from the finished, sterilised (when supplied sterile)
device.
Page | 31
7.5 Sterilisation
Where the device is supplied sterile, the dossier should contain the detailed information of
the initial sterilisation validation including sterilizer qualification, bioburden testing,
pyrogen testing, testing for sterilant residues (if applicable) and packaging validation as
per recognized standards e.g. ISO 11607.
Typically, the detailed validation information should include the method used, sterility
assurance level attained, standards applied, the sterilisation protocol developed in
accordance with recognized standards e.g ISO 11137, and a summary of results.
Evidence of the ongoing revalidation of the process should also be provided. Typically
this would consist of arrangements for, or evidence of, revalidation of the packaging and
sterilisation processes.
Page | 32
Page | 33
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
Annexure VII
The list shall bear name and address of manufacturer, license number, validity period and undertaking.
Heart Valve
Name of firm & address of firm as per Form 28 in each & every page and Page Number.
Lic No.
Validity period
S.no
Model
name
Generic
name
MRI
Compli
ant
viz. Yes
or No
Adult /
Material of Size
Paediatric Construction s in
mm
Annulus
Diameter
10
Internal
Other
orifice Attribute
Diameter
s
(Interfer
ence
compen
sation)
viz.
Rotatabl
e valve;
x-ray
visibility
11
12
13
14
Intende
d Use
Sterile
/Non
Sterile
Self-life
Export/
Domestic
Licensing Authority
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GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
Model
name
Generic
name
Name of the
coated Drug
(in case of
DES)
Validity period
Stent
length
in mm
Stent
diameter in
mm
Material of
Construction
Intended Use
Self-life
Export/
Domestic
Licensing Authority
Page | 35
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
S.no
Model
name
Generic
name
Overall
length
Validity period
Optic
Design
Dialing
Whole
Materi
al of
Constr
uction
Multi Piece
/ single
piece
Intended
Use
Sterile/
Non
Sterile
Export/
Domestic
Note:- Product Description like as foldable hydrophilic acrylic intraocular lens, hydrophobic acrylic foldable intra ocular lens, PMMA intra
ocular lens, single /multi piece acrylic foldable intraocular lens, hydrophilic foldable poly hydroxyl ethyl methacrylate intraocular lens with
dual haptic & square edge, single piece PMMA intraocular lens, natural yellow hydrophilic acrylic foldable aspheric square edge
intraocular lens etc. needs to be mentioned on the List.
Licensing Authority
Page | 36
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
Orthopedic Implant
Name of firm & address of firm as per Form 28 in each & every page and Page Number.
Lic No.
S.no
Validity period
Model
name
Generic
name
Length
in mm
Diameter
in mm
Other
information
Like Hole
etc.
Material of
Construction
Sterile
/Non
Sterile
Selflife
Export/
Domestic
Note:- In case the orthopaedic Implants are Coated then details of Coating Material along with specifications needs to be mentioned on
the list
Licensing Authority
Page | 37
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
Catheters
Name of firm & address of firm as per Form 28 in each & every page and Page Number.
Lic No.
Validity period
S.no
Model
name
Generic
name
Length
in mm
Diameter
in mm
Material of
Construction
Intended
Use
Sterile
/Non
Sterile
Selflife
Export/
Domestic
Note:- In case the Catheters are Coated then details of Coating Material along with specifications needs to be mentioned on the list
Licensing Authority
Validity period
Model
name
Generic
name
Length
in mm
Diameter
in mm
Material of
Construction
Intended
Use
Sterile
/Non
Sterile
Selflife
Export/
Domestic
Licensing Authority
Page | 38
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
I.V cannula
Name of firm & address of firm as per Form 28 in each & every page and Page Number.
Lic No.
S.no
Validity period
Model
name
Generic
name
Length
in mm
Diameter
in mm
Material of
Construction
Intended
Use
Sterile
/Non
Sterile
Selflife
Export/
Domestic
Licensing Authority
Bone Cement
Name of firm & address of firm as per Form 28 in each & every page and Page Number.
Lic No.
S.no
Model
name
Validity period
Generic
name
Composition
Intended Use
Sterile/Non
Sterile
Self-life
Export/
Domestic
Note:- In case the antibiotics are used then details of antibiotic along with specifications needs to be mentioned on the list
Licensing Authority
Page | 39
GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED MEDICAL DEVICES UNDER CLAA SCHEME
Validity period
Model
name
Generic
name
Dimension
In mm
Bulk
Density
Material of
Construction
Pore
Size
Hardness
Intended
Use
Sterile
/Non
Sterile
Self-life
Export/
Domestic
Licensing Authority
(Sd/-)
Proprieter/Partner/Director.
Note:- The undertaking is common for the all category of the product list of Medical Devices
Page | 40