**Executive Summary:**
This notice from the Central Drugs Standard Control Organisation (CDSCO), dated October 9, 2020, lists Medical Device Testing Laboratories (MDTL) registered for medical device testing, without CDSCO endorsement. It provides the names, addresses and scope of testing for each registered laboratory.
**Key Points / Main Content:**
* **Registered Medical Device Testing Laboratories (MDTL):** The notice lists MDTLs that are registered to perform medical device testing.
* **Laboratory Details:** The list includes the name, address, registration number, and scope of testing for each listed laboratory.
* **Scope of Testing:** Details the specific tests each laboratory is certified to perform.
* **LM I Ms IS TI EP DRA LABS:** Testing includes Copper T, Condoms, Sterile Hypodermic Needles, Tubal Rings, Hypodermic Syringes, Blood Bags.
* **Pm as th S Lta ar b I Pm va t.g i Ln tg d.:** Testing includes Bilirubin Total and Direct Test Reagents Kits, Creatinine test reagent kit, Aspartate Amino Transferase AST SGOT test, Alanine Amino Transferase ALTSGPT test, Now. Uric Acid Test reagents kits, Total Protein test reagents kits, Activated partial thromboplastin time APTT test, PT Prothrombin Time Test reagents Kits
* **Ms Alcatec Research Laboratories India Pvt. Ltd.:** Testing includes Sterilized Surgical Ligatures, Sterilized Disposable Device, Sterilized Surgical Sutures
* **Ms Sree Chitra Tirunal Institute For Medical Sciences & Technology:** Testing includes Cardio Vascular Devices Biological Evaluation as per ISO 10993, Neuroprosthesis Biological Evaluation as per ISO 10993, Orthopedic Implants Biological Evaluation as per ISO 10993, All medical devices and Materials Biological Evaluation as per ISO 10993, Dental Implants Biological Evaluation as per ISO 10993
* **Ms, GLR Laboratories Private Limited:** Testing includes Cardiovascular devices Biological evaluation as per ISO 10993, Orthopaedic devices Biological evaluation as per ISO 10993, Ocular devices Biological evaluation as per ISO 10993, Surgical devices and sutures Biological evaluation as per ISO 10993, Respiratory devices Biological evaluation as per ISO 10993, Gastrointestinal devices Biological evaluation as per ISO 10993, Urological devices Biological evaluation as per ISO 10993, Haematological devices and IV sets Biological evaluation as per ISO 10993, Dental devices Biological evaluation as per ISO 10993, Personal care products and family planning Biological evaluation as per ISO 10993, Neurological devices Biological evaluation as per ISO 10993, All medical devices and Materials Biological evaluation as per ISO 10993
* **BM Is O, S P CA IL ENA CM EU SR PRIVATE LIMITED:** Testing includes Catheters Biological Toxicity, Disposable Hypodermic needles Biological Toxicity, Surgical dressings Biological Toxicity, Orthopaedic Implants Biological Toxicity, Blood Bags Biological Toxicity, Drug eluting stent Biological Toxicity, Intra Ocular Lenses Biological Toxicity, Sutures Biological Toxicity, Condoms Biological Toxicity, Heart Valves Biological Toxicity, Disposable perfusion sets Biological Toxicity, Cardiac stent Biological Toxicity, Copper T Biological Toxicity, Scalp Vein Set Biological Toxicity
* **AM ds v, i nE uur so Lf ii mn is t ed:** Testing includes Disposable Perfusion Sets, Cardiac Stents, Drug Eluting Stents, Blood Bags, Catheters Class D, Catheters Class B, Catheters Class C, Heart valves, Intra Ocular Lenses, 1.V. Cannula, Bone Cements, Internal Prosthetic Replacements, Peritoneal dialysis sets, Condoms, Intrauterine devices, Surgical dressing, Scalp Vein Set, Ligatures and sutures
* **AM Ns A, L T YR TU IS CT AI LN SOLUTIONS PRIVATE LIMITED:** Testing includes Disinfectant Sterility and Antimicrobial activities as per ISO 117371 and 2, USP 9.0, IP 2018, BP 2018, Catheters Sterility, Bioburden and BET as per ISO 117371 and 2, USP 42, EP 9.0, IP 2018, BP 2018, Surgical Sutures Physical parameters, Sterility and BET as per ISO 117372, USP 42, EP 9.0, IP 2018, BP 2018, Surgical Dressings Sterility , Bioburden, BET as per IS 758, IS 1954, ISO 117371and 2, IP 2018, USP 42, BP 2018 and ENQ.0, Blood bags with and without anticoagulant solutions Mechanical, Sterility and BET as per ISO 3826, IS 15102, ISO 117372, USP42, EP 9.0, IP 2018, BP 2018, Contraceptives Condoms MaleFemale Condoms Mechanical parameters, Bioburden and Pathogens as per ISO 40742015, WHOUNAIDS2010, 1S0258412017, WHOUNAIDS2012,Schedule R, 10117371, IP 2018, USP42, Disposable Hypodermic Needles Sterility, Bioburden and BET as per ISO 117371 and 2, USP 42, EP 9.0, IP 2018, BP 2018, Disposable Perfusion sets Physical testing, Sterility, Bioburden and BET as per ISO 1135Part 4, IS 98243, ISO 117371 and 2, USP 42, EP 9.0, IP 2018, BP 2018, Intraocular Lenses Sterility, Bioburden, BET and Pathogen identification as per ISO 11737 Part 1 and 2, USP 42, EP 9.0, IP 2018, BP 2018, Orthopaedic Implants Sterility, Bioburden and BET as per ISO 117371 and 2, USP 42, EP 9.0, IP 2018, BP 2018, Cardiac Stents Sterility test as per 1SO117372, USP 42, EP 9.0, IP 2018, BP2018, Contraceptives CuT Mechanical Parameters, Sterility, Bioburden as per WHO UNFPA 2016, ISO 7439, ISO 117371and 2, IP 2018, USP 42, BP 2018, EP 9.0, Disposable Hypodermic Syringes Sterility and BET as per ISO 117372, USP 42, EP 9.0, IP 2018, BP 2018, Internal Prosthetic Replacements Sterility test as per ISO 117372, USP 42, EP 9.0, IP 2018, BP 2018, Heart Valves Sterility test as per ISO 117372, USP 42, EP 9.0, IP 2018, BP 2018, Contraceptives Tubal RingMechanical parameters and Sterility as per IS 13009 2000, ISO 117372, USP 42, EP 9.0, P2018, BP 2018, IV Cannulae Sterility, Bioburden, Pathogen identification as per ISO 117371and 2, USP 42, EP 9.0, IP 2018 , BP 2018
* **Ms, Devansh Testing Research Laboratory Pvt. Ltd:** Testing includes Catheters Excluding Bio compatibility testing, Disposable Perfusion Sets Excluding Biocompatibility testing, Disposable Hypodermic Needles Excluding Bio compatibility testing, Disposable Hypodermic Syringes, I.V. Cannulae, Scalp Vein Set, Surgical Dressings, Contraceptives, Disinfectant
* **Ms, JAGDAMBA LABORATORIES:** Testing includes Catheters Test as per ISISO 10555, Disinfectants As per IP, BP, USP, Disposable Hypodermic Needles Test as per IS 10654, Disposable Perfusion Sets Test as per IS 12655, LV. Cannulae Test as per ISISO 10555, Disposable Hypodermic Syringes Test as per 1S10258, Scalp vein set Test as per IS 16097, Surgical Dressings Cotton and Gauze, Bandage
**Impact Analysis**
**Medical Device Manufacturers:**
* *Impact:* Manufacturers need to be aware of the listed registered MDTLs and their specific testing capabilities.
* *Action Required:* Verify that chosen testing laboratories are registered and have the appropriate scope for the devices being tested.
**Medical Device Testing Laboratories (MDTLs):**
* *Impact:* MDTLs need to ensure they are accurately represented in the list and that their scope of testing is correctly stated.
* *Action Required:* Review the information provided in the notice and communicate any discrepancies to CDSCO.
**Central Drugs Standard Control Organisation (CDSCO):**
* *Impact:* CDSCO is responsible for maintaining and updating the list of registered MDTLs.
* *Action Required:* Continue to monitor and regulate MDTLs to ensure compliance with standards.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India involved in health services.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
Hyderabad, Telangana: City in Telangana, India; location of LMI MS IS TI EP DRA LABS.
West Delhi, Delhi: District in Delhi, India; location of PM as th S Lta ar b I Pm va t.g i Ln tg d..
Bahadurgarh, Haryana: City in Haryana, India; location of Ms Alcatec Research Laboratories India Pvt. Ltd.
Thiruvananthapuram, Kerala: City in Kerala, India; location of Sree Chitra Tirunal Institute For Medical Sciences & Technology.
Chennai, Tamil Nadu: City in Tamil Nadu, India; location of GLR Laboratories Private Limited and AM Ns A, L T YR TU IS CT AI LN SOLUTIONS PRIVATE LIMITED.
Peenya Industrial Area, Bengaluru, Karnataka: Industrial area in Bengaluru, Karnataka, India; location of AM ds v, i nE uur so Lf ii mn is t ed.
No. 29/Misc/03/2019-Dc
(211)
Government
of India
Directorate
General of Health Services
Central Drugs Standard Control Organisation
(Medical Devices and Diagnostics
Division)
Dated: 9 9 OCT 2020
NOTICE
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NAME & ADDRESS
OF MEDICAL DEVICE REGISTRATION
TESTING
NO
LABORATORY SCOPE OF TESTING
LM I/ Ms IS TI EP DRA LABS TL/MD/2019/000001
| 1. Copper -T
Address: 7-2-
2. Condoms
1813/5/A, Adj. To Post 3. Sterile Hypodermic Needles
Office, Industrial 4. Tubal Rings
Estate, Sanathna gar, 5. Hypodermic Syringes
Telangana,
6. Blood Bags
Hyderabad- 500018
PM as
th
S Lta ar
b
I Pm va t.g i Ln tg
d.
& TL/MD/2019/000002
. Bilirubin (Total and Direct) Test
Address: 4B/4, Tilak Reagents / Kits
Nagar , West Delhi, 2. Creatinine test reagent / kit
Delhi (India) - 110018 3. Aspartate Amino Transferase
(AST / SGOT) test
4. Alanine Amino Transferase
(ALT/SGPT)
test
NOW. Uric Acid Test reagents / kits
. Total Protein test reagents / kits
. Activated partial thromboplastin
time (APTT) test
8. PT (Prothrombin
Time) Test
reagents / KitsTL/MD/2019/000003 | 1. Sterilized Surgical Ligatures
M/s Alcatec 2. Sterilized Disposable Device
Research 3.Sterilized Surgical Sutures
Laboratories India
Pvt. Ltd.
Address: 1652 MIE
Part B, Bahadurgarh,
Haryana — 124507
TL/MD/2019/000004 4.Cardio Vascular Devices
M/s Sree Chitra (Biological Evaluation as per
Tirunal Institute For
ISO 10993)
Medical Sciences & 2.Neuroprosthesis (Biological
Technology Evaluation as per ISO 10993)
Address: Medical 3. Orthopedic Implants (Biological
College, Evaluation as per ISO 10993)
Thiruvananthapuram, 4.All medical devices and
Kerala - 695011 Materials (Biological Evaluation
as per ISO 10993)
5. Dental Implants (Biological
Evaluation as per ISO 10993)
TL/MD/2019/000005 } 1.
Cardiovascular devices
M/s, GLR (Biological evaluation as per
Laboratories Private
ISO 10993)
Limited 2. Orthopaedic devices
Address: GOKULAM (Biological evaluation as per
STREET, Mathur,
ISO 10993)
MATHUR, Chennai, 3. Ocular devices (Biological
Tamil Nadu - 600068 evaluation as per ISO 10993)
4. Surgical devices and sutures
(Biological evaluation as per
5. I ReS sO p i1 r0 a9 t9 o3 r) y devices (Biological
evaluation as per ISO 10993)
6.
Gastrointestinal devices
(Biological evaluation as per
ISO 10993)
7. Urological devices (Biological
evaluation as per ISO 10993)
8. Haematological devices and
lV sets (Biological evaluation
as per ISO 10993)
9. Dental devices (Biological
evaluation as per ISO 10993)
40.Personal care products and
family planning (Biological
evaluation as per |SO 10993)
41.Neurological devices
(Biological evaluation as per
ISO 10993)
12.All medical devices and
Materials (Biological
evaluation as per ISO 10993)
Page 2 of 9>-
BM/ Is O,
S
P CA IL ENA CM EU SR TL/MD/2019/000006
| 1. Catheters (Biological Toxicity)
PRIVATE LIMITED 2. Disposable Hypodermic
Address: 401 Aikya, needles (Biological Toxicity)
4th Floor, H.No-10-3- 3. Surgical dressings (Biological
32/9/23, Opp.Faust Toxicity)
High School,East 4. Orthopaedic Implants
Marredpally, (Biological Toxicity)
Secunderabad, 5. Blood Bags (Biological
Hyderabad,
Toxicity)
Telangana - 500026 6. Drug eluting stent (Biological
Toxicity)
7. Intra Ocular Lenses (Biological
Toxicity)
8. Sutures (Biological Toxicity)
9. Condoms (Biological Toxicity)
10. Heart Valves (Biological
Toxicity)
11. Disposable perfusion sets
(Biological Toxicity)
12. Cardiac stent (Biological
Toxicity)
13. Copper- T (Biological Toxicity)
14. Scalp Vein Set (Biological
Toxicity)
AM d/s v,
i
nE uur so Lf ii mn is
t ed
TL/MD/2020/000001
1|1. Disposable Perfusion Sets
Address: 21 & 22, 2. Cardiac Stents
Phase Il, Peenya 3. Drug Eluting Stents
Industrial Area, 4. Blood Bags
Bengaluru 5. Catheters (Class D)
Pincode 560 058, 6. Catheters (Class B)
INDIA, Bangalore, 7. Catheters (Class C)
Bengaluru 8. Heart valves
(Bangalore) Urban, 9. Intra Ocular Lenses
Karnataka - 560058 10.1.V. Cannula
11.Bone Cements
12. Internal Prosthetic
Replacements
13. Peritoneal dialysis sets
14.Condoms
15. Intra-uterine devices
16. Surgical dressing
17. Scalp Vein Set
18. Ligatures and sutures
AM/ Ns A,
L
T YR TU IS CT AI LN TL/MD/2020/000002
1. Disinfectant ( Sterility and
SOLUTIONS Antimicrobial activities as per
PRIVATE LIMITED ISO 11737-1 and 2, USP
Address: Plot no- 42, EP 9.0, IP 2018, BP 2018)
-303/b, Block-B, 2. Catheters (Sterility, Bioburden
RK Complex, 15 and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
Page 3 of 9
e
e2018, BP 2018) - Class A
Floor, Thiruneermalai 3. Surgical Sutures (Physical
road, Parvat hy puram, parameters, Sterility and BET
Chrompet , ,
as per ISO 11737-2, USP
Chennai, 42, EP 9.0, IP 2018, BP 2018)
Kanchipuram, Tamil
- Class B
Nadu - 600044
4. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
ENQ.0) - Class A
5. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
ENQ.0) - Class B
6. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
ENQ.0) - Class C
7. Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
ENQ.0) - Class D
8. Blood bags with and without
anticoagulant solutions
(Mechanical, Sterility and BET
as per ISO 3826, IS 15102,
ISO 11737-2, USP42, EP 9.0,
IP 2018, BP 2018)
9. Contraceptives (Condoms -
Male/Female Condoms)
(Mechanical parameters,
Bioburden and Pathogens as
per ISO 4074-2015,
WHOUNAIDS2010,
1S025841-2017,
WHOUNAIDS2012,Schedule
R, 1$011737-1, IP 2018,
USP42
40. Catheters (Sterility, Bioburden
and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class B
41.Catheters (Sterility, Bioburden
and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class C
42. Disposable Hypodermic
Needles (Sterility, Bioburden
Page 4 of 9and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class C
13. Disposable Perfusion sets
(Physical testing, Sterility,
Bioburden and BET as per
ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class B
14. Disposable Perfusion sets
(Physical testing , Sterility,
Bioburden and BET as per
ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class C
15. Intraocular Lenses (Sterility,
Bioburden, BET and Pathogen
identification as per ISO 11737
- Part 1 and 2, USP 42, EP
9.0, IP 2018, BP 2018)
16. Orthopaedic Implants (Sterility,
Bioburden and BET as per
ISO 11737-1 and
2, USP 42, EP 9.0, IP 2018,
BP 2018) - Class C
17. Orthopaedic Implants (
(Sterility, Bioburden and BET
as per ISO 11737-1 and 2,
USP 42, EP 9.0, IP 2018, BP
2018) - Class D
18. Cardiac Stents ( Sterility test
as per 1SO11737-2,
USP 42,
EP 9.0, IP 2018, BP2018)-
Class C
19. Cardiac Stents ( Sterility test
as per ISO 11737-2, USP 42,
EP 9.0, IP 2018, BP2018) -
Class D
20. Contraceptives
(CuT)
(Mechanical
Parameters, Sterility,
Bioburden as per
WHO UNFPA 2016, ISO 7439,
ISO 11737-1and 2, IP 2018,
USP 42, BP 2018, EP 9.0)
21. Disposable Hypodermic
Syringes (Sterility and BET as
per ISO 11737-2, USP 42, EP
9.0, IP 2018, BP 2018) - Class
B22. Catheters (Sterility, Bioburden
and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class D
23. Disposable Hypodermic
Needles (Sterility, Bioburden
and BET as per ISO 11737-1
and 2, USP 42, EP 9.0, IP
2018, BP 2018) - Class B
24. Disposable Perfusion sets
(Physical testing, Sterility,
Bioburden and BET as per
ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class A
25. Disposable Perfusion sets
(Physical testing, Sterility,
Bioburden and BET as per
ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class C
26. Intraocular Lenses (Sterility,
Bioburden, BET and Pathogen
identification as per ISO 11737
_ Part 1 and 2, USP 42, EP9.0,
IP 2018, BP 2018)
27 |nternal Prosthetic
Replacements (Sterility test as
per ISO 11737-2, USP 42,
EP 9.0, IP 2018, BP 2018)
28. Heart Valves (Sterility test as
per ISO 11737-2, USP 42, EP
9.0, IP 2018, BP 2018)
29. Surgical Sutures (Physical
parameters, Sterility and BET
as per ISO 11737-2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class A
30. Surgical Sutures (Physical
parameters, Sterility and BET
as per ISO 11737-2, USP 42,
EP 9.0, IP 2018, BP 2018) -
Class C
31.
Contraceptives (Tubal
Ring)(Mechanical parameters
and Sterility as per IS 13009-
2000, ISO 11737-2, USP 42,
EP 9.0, P2018, BP 2018)
32. Disposable Perfusion sets
(Physical testing, Sterilit
Page 6 of 9Bioburden and BET as per
ISO 1135-Part 4, IS 9824-3,
ISO 11737-1 and 2, USP 42,
EP 9.0, IP 2018, BP 2018)-
Class B .
33. Internal Prosthetic
Replacements
(Sterility test as
per ISO 11737-2, USP 42, EP
9.0, IP 2018, BP 2018)
34. IV Cannulae (Sterility,
Bioburden, Pathogen
identification
as per ISO
11737-1and 2, USP 42, EP
9.0, IP 2018 , BP 2018)
35. Disposable Hypodermic
Syringes (Sterility and BET as
per ISO 11737-2, USP 42,
EP9.0, IP 2018, BP 2018)
M/s, Devansh
Testing & Research
TL/MD/2020/000003
11. Catheters ~ Class A
Laboratory Pvt. Ltd, Catheters (Excluding Bio-
Address: RZ-21A/331, compatibility testing) - Class B
Madanpuri, Gali No.- 3. Catheters (Excluding Bio-
10, West Sagar Pur, compatibility testing)- Class C
Delhi, West Delhi, Disposable Perfusion Sets
Delhi - 110046 (Excluding Biocompatibility
testing) - Class C
5. Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) - Class C
Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) - Class D
Disposable Hypodermic
Syringes - Class A
8. Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class B
9. Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class C
10. Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class D
11. 1.V. Cannulae - Class A
12. I.V. Cannulae (Excluding Bio-
compatibility testing) - Class B
13. IV. Cannulae (Excluding Bio-
compatibility testing) - Class C
14. IV. Cannulae (Excluding Bio-
compatibility testing) - Class D
15. Scalp Vein Set - Class A
Page 7 of 9
e
eScalp Vein Set (Excluding |
16.
Biocompatibility testing) -
Class B
Scalp Vein Set (Excluding
Kea
Biocompatibility testing) -
Class C
Scalp Vein Set (Excluding
18.
Biocompatibility testing) -
Class D
Surgical Dressings - Class A
19.
Surgical Dressings (Excluding
20.
Biocompatibility testing) -
Class B
Surgical Dressings (Excluding
21.
Biocompatibility testing) -
Class C
Surgical Dressings (Excluding
22.
Biocompatibility testing) -
Class D
_ Contraceptives - Class A
_ Contraceptives (Excluding
Biocompatibility testing) -
Class B
Contraceptives (Excluding
25.
Biocompatibility testing) -
Class C
Contraceptives (Excluding
26.
Biocompatibility testing) -
Class D
Disinfectant - Class A
27.
Catheters (Excluding Bio-
28.
compatibility testing) - Class D
Disposable Hypodermic
29.
Needles - Class A
Disposable Hypodermic
30.
Needles (Excluding Bio-
compatibility testing) - Class B
Disinfectant (Excluding Bio-
31.
compatibility testing) - Class B
Disinfectant (Excluding Bio-
32.
compatibility testing) - Class C
Disinfectant (Excluding Bio-
33.
compatibility testing) - Class D
Disposable Perfusion Sets -
34.
Class A
Disposable Perfusion Sets
35.
(Excluding Biocompatibility
testing) - Class B
Disposable Perfusion Sets
36.
(Excluding Biocompatibility
|
testing)
Page 8 of 910 M/s, JAGDAMBA TL/MD/2020/000004 . Catheters (Test as per IS/ISO
LABORATORIES 10555) - Class A
Address: 119, . Disinfectants (As per IP, BP,
Solitaire Industrial USP) - Class B
Park, Phase-1, . Disposable Hypodermic
Dahmikallan, Bagru, Needles (Test as per IS 10654)
Jaipur, Rajasthan- - Class B
303007 . Disposable Perfusion Sets (Test
as per IS 12655) - Class A
. Disposable Perfusion Sets (Test
as per IS 12655) - Class B
. Catheters (Test as per IS/ISO
10555) - Class B
. LV. Cannulae (Test as per
IS/ISO 10555) - Class B
. Disposable Hypodermic
Syringes (Test as per 1S10258)
- Class B
. Scalp vein set (Test as per IS
16097) - Class B
10. Surgical Dressings (Cotton
and Gauze, Bandage)-Class B
11. Surgical Dressings (Cotton
and Gauze, Bandage)-Class A
\
a
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
IT Cell for uploading the information on the CDSCO website.
Page 9 of 9