See Full Document Text
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: ¢F/ e742
NOTICE
Subject: List of medical devices testing laboratory (MDTL) for carry out test or
evaluation of medical device on behalf of manufacturer registered with CDSCO
under MDR 2017- reg.
As you are aware that Medical Devices Rules 2017 has already been published vide
GSR_ 78(E) dated 31.01.2017 under Drugs and Cosmetics Act to regulate the
manufacture, import, sale and distribution of the medical devices and said rules are
effective from 01.01.2018
The updated list of medical devices testing laboratories registered with CDSCO up
till under rule 81 in the provisions of Medical Devices Rules, 2017 to carry out test or
evaluation of a medical device on behalf of manufacturer is given below & there are
more applicants which are under evaluation
NAME & ADDRESS |
_ SI. OF MEDICAL DEVICE) REGISTRATION SCOPE OF TESTING
No. TESTING | NO.
| LABORATORY
'1 | M/s SIPRALABS TL/MD/2019/000001 | 1. Copper -T
| | LIMITED 2. Condoms
| Address: 7-2- 3. Sterile Hypodermic Needles
| 1813/5/A, Adj. To Post | 4. Tubal Rings
| | Office, Industrial 5. Hypodermic Syringes
| | Estate, Sanathnagar, 6. Blood Bags
| Telangana,
| Hyderabad- 500018
|
|2 T| Mls Star Imaging & TL/MD/2019/000002 | 1. Bilirubin (Total and Direct) Test
Path Lab Pvt. Ltd. Reagents / Kits
Address: 4B/4,. Tilak) . Creatinine test reagent / kit
/Nagar , West Delhi,
Wh
| _ 3. Aspartate Amino Transferase
| Delhi (India) - 110018 | (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 / Kits
Page 1 of 11| 3 | Mls Alcatec | TL/MD/2019/000003 | 1. Sterilized Surgical Ligatures
| Research 2. Sterilized Disposable Device
| | Laboratories India | 3.Sterilized Surgical Sutures |
|
| Pvt. Ltd.
|
|Address: 1652 MIE.
| Part B, Bahadurgarh, | |
| Haryana ~ 124507 |
4 | Mis Sree Chitra TL/MD/2019/000004 |1.Cardio Vascular Devices +
i |
Tirunal Institute For (Biological Evaluation as per |
|_| Medical Sciences & | | ISO 10993)
| | Technology | 2. Neuroprosthesis (Biological
| | A Cd old lr ee gs es ,: Medical || | ‘ 3. E Ov ra tl hu oa pt ei do in c a Is m pp le ar n tI sS O ( B1 io0 l9 o9 g3 i) cal
| | Thiruvananthapuram, Evaluation as per ISO 10993)
| | Kerala - 695011 | 4.All medical devices and
| | Materials (Biological Evaluation
as per ISO 10993)
|
5.Dental Implants (Biological
|
| Evaluation as per ISO 10993)
hb M/s, GLR TL/MD/2019/000005/|1. Cardiovascular devices
| Laboratories Private (Biological evaluation as per
| | Limited ISO 10993)
| Address: GOKULAM 2. Orthopaedic devices
| STREET, Mathur,
(Biological evaluation as per
| MATHUR, Chennai, ISO 10993)
| Tamil Nadu - 600068 3. Ocular devices (Biological
evaluation as per ISO 10993)
| 4. Surgical devices and sutures
(Biological evaluation as per
ISO 10993)
5. Respiratory devices (Biological
| evaluation as per ISO 10993)
'6. Gastrointestinal devices
(Biological evaluation as per
ISO 10993)
Urological devices (Biological
evaluation as per ISO 10993)
Haematological devices and
\V sets (Biological evaluation
as per ISO 10993)
oO: Dental devices (Biological
evaluation as per ISO 10993)
10. Personal care products and
family planning (Biological
evaluation as per ISO 10993)
11.Neurological devices
(Biological evaluation as per
ISO 10993)
12. All medical devices and
Materials (Biological
evaluation as per ISO 10993)
Page 2 of 116 | M/s, PALAMUR TL/MD/2019/000006 | 1. Catheters (Biological Toxicity)
| BIOSCIENCES |2. Disposable Hypodermic
| PRIVATE LIMITED
| Address: 401 Aikya,
needles (Biological Toxicity)
3. Surgical dressings (Biological
| Ath Floor, H.No-10-3-
Toxicity)
32/9/23, Opp.Faust 4. Orthopaedic Implants
High School,East (Biological Toxicity)
Marredpally, 5. Blood Bags (Biological
| Secunderabad, Toxicity)
Hyderabad,
6. Drug eluting stent (Biological
| Telangana - 500026 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)
7 | Mls, Eurofins TL/MD/2020/000001 1. Disposable Perfusion Sets
| Advinus Limited '2. Cardiac Stents
| | Address: Zee: 3. Drug Eluting Stents
| Phase II, Peenya | 4. Blood Bags
Industrial Area, | |5. Catheters (Class D)
| Bengaluru 6. Catheters (Class B)
| | Pincode 560 058, | 7. Catheters (Class C)
|| INDIA, Bangalore, | 8. Heart valves
| Bengaluru | 9. Intra Ocular Lenses
| (Bangalore) Urban, | 10.1.V. Cannula
| Karnataka - 560058 |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
| |
'8 | M/s, TRUSTIN | TL/MD/2020/000002 |1. Disinfectant ( Sterility and
_ ANALYTICAL | Antimicrobial activities as per
| SOLUTIONS ISO 11737-1 and 2, USP
| PRIVATE LIMITED 42, EP 9.0, IP 2018, BP 2018)
| Address: Plot no-
|2. Catheters (Sterility, Bioburden
| 303/b, Block-B,
and BET as per ISO 11737-1
| RK Complex, 1*
and 2, USP 42, EP 9.0, IP
Page 3 of 11Floor, Thiruneermalai 2018, BP 2018) - Class A
road, Parvathy puram,
Surgical Sutures (Physical
parameters, Sterility and BET
Chrompet, ,
as per ISO 11737-2, USP
Chennai,
Kanchipuram, Tamil 42, EP 9.0, IP 2018, BP 2018)
Nadu - 600044 - Class B
Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
EN9.0) - Class A
Surgical Dressings ( Sterility ,
Bioburden, BET as per IS 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
EN9Q.0) - Class B
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
Surgical Dressings ( Sterility ,
Bioburden, BET as per |S 758,
IS 1954, ISO 11737-1and 2, IP
2018, USP 42, BP 2018 and
EN9.0) - Class D
Blood bags with and without
anticoagulant solutions
(Mechanical, Sterility and BET
as per ISO 3826, IS 15102,
ISO/14737-2, USP42, EP 9:0,
IP 2018, BP 2018)
Contraceptives (Condoms -
Male/Female Condoms)
(Mechanical parameters,
Bioburden and Pathogens as
per ISO 4074-2015,
WHOUNAIDS2010,
1S$O025841-2017,
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
Al
Catheters (Sterility, Bioburden
and BET as per ISO 11737-1
and 2:USP42¢ER%9.07IP
2018, BP 2018) - Class C
12. Disposable Hypodermic
Needles (Sterility, Bioburden
|
Page 4 of 11and 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;.|P 2018, BR 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 |
nae) |
Page 5 of 11(22. 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)
[27Internal 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
Contraceptives (Tubal
Ring)(Mechanical parameters
and Sterility as per IS 13009-
2000, ISO 11737-2, USP 42,
EP 9.0, IP2018, BP 2018)
| 32. Disposable Perfusion sets
(Physical testing, Sterility, |
Page 6 of 11| 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
|
33. Internal Prosthetic
Replacements (Sterility test as
per ISO. 11737-2, USP 42, EP
9.0, IP 2018, BP 2018)
(34.1V Cannulae (Sterility,
Bioburden, Pathogen
identification as per ISO
11737-1and 2, USP 42, EP
| 9,0, [Pi2018 BR: 2018)
35. Disposable Hypodermic
Syringes (Sterility and BET as
per ISO 11737-2, USP 42,
EP9.0, IP 2018, BP 2018)
=
|
|
M/s, Devansh | TL/MD/2020/000003 Catheters — Class A
Testing & Research Catheters (Excluding Bio-
Laboratory Pvt. Ltd. compatibility testing) - Class B
Address: RZ-21A/331, Catheters (Excluding Bio-
Madanpuri, Gali No.- compatibility testing)- Class C
10, West Sagar Pur, Disposable Perfusion Sets
Delhi, West Delhi, (Excluding Biocompatibility
| Delhi - 110046 testing) - Class C
Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) - Class C
Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) - Class D
Disposable Hypodermic
Syringes - Class A
Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class B
Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class C
. Disposable Hypodermic
Syringes (Excluding Bio-
compatibility testing) - Class D
. LV. Cannulae - Class A
. LV. Cannulae (Excluding Bio-
compatibility testing) - Class B
. 1. Cannulae (Excluding Bio-
compatibility testing) - Class C
. LV. Cannulae (Excluding Bio-
compatibility testing) - Class D
. Scalp Vein Set - Class A
Page 7 of 1116. Scalp Vein Set (Excluding
Biocompatibility testing) -
Class B
We Scalp Vein Set (Excluding
Biocompatibility testing) -
Class C
18. Scalp Vein Set (Excluding
Biocompatibility testing) -
Class D
19:
Surgical Dressings - Class A
20. Surgical Dressings (Excluding
Biocompatibility testing) -
Class B
21. Surgical Dressings (Excluding
Biocompatibility testing) -
Class C
22. Surgical Dressings (Excluding
Biocompatibility testing) -
Class D
23.
Contraceptives - Class A
24.
Contraceptives (Excluding
Biocompatibility testing) -
Class B
25.
Contraceptives (Excluding
Biocompatibility testing) -
Class C
26. Contraceptives (Excluding
Biocompatibility testing) -
Class D
2. Disinfectant - Class A
28.
Catheters (Excluding Bio-
compatibility testing) - Class D
29.
Disposable Hypodermic
Needles - Class A
30. Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) - Class B
31. Disinfectant (Excluding Bio-
compatibility testing) - Class B
32. Disinfectant (Excluding Bio-
compatibility testing) - Class C
33.
Disinfectant (Excluding Bio-
compatibility testing) - Class D
34. Disposable Perfusion Sets -
Class A
30, Disposable Perfusion Sets
(Excluding Biocompatibility
testing) - Class B
36.
Disposable Perfusion Sets
(Excluding Biocompatibility
testing)
Page 8 of 11/10 | M/s, JAGDAMBA | TLIMD/2020/000004
| ALdAdBreOsRsA: T1O19R,IES
| Solitaire Industrial
Park, Phase-1,
Dahmikallan, Bagru,
Jaipur, Rajasthan-
| 303007
|1. Catheters (Test as per IS/ISO
10555) - Class A
. Disinfectants (As per IP, BP,
USP) - Class B
. Disposable Hypodermic
Needles (Test as per IS 10654)
- Class B
. 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/SO 10555) - Class B
. Disposable Hypodermic
| || -S yCrliansgse sB (Test as per 1S10258)
| | 9. 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
'11 | ITLLABS PVT LTD TL/MD/2021/000001 |1. Catheters (Excluding Bio-
| B-283-284, compatibility testing) Class D
Mangolpuri Industrial 2. Surgical Dressings (Excluding
| | Area, Phase |, North Biocompatibility testing) Class D
| West Delhi, 3. Disposable Hypodermic
| Delhi - 110083 Syringes Class D
| | 4. Disposable Hypodermic
| Syringes (Excluding Bio-
| compatibility testing) Class D
| | 5. Surgical Dressings Class D
| 6. Disposable Hypodermic
| Needles (Excluding Bio-
| compatibility testing) Class C
| 7. Contraceptives Class D
| 8. 1.V. Cannulae (Excluding Bio-
compatibility testing) Class C
9. Surgical Dressings (Excluding
Biocompatibility testing) Class D
10. Scalp Vein Set (Excluding
| | Biocompatibility testing) Class B
11. Disposable Hypodermic
| | | Needles Class C
7 Soe) 12. IV. Cannulae Class C
in 13. .V. Cannulae (Excluding Bio-
| | compatibility testing) Class C
114. Scalp Vein Set Class B
| 15. Contraceptives (Excluding
Page 9 of 11Biocompatibility testing) Class D |
NG: Catheters Class D
Disinfectant Class B |
ies
Disposable Perfusion Sets |
18.
(Excluding Biocompatibility |
testing) Class C |
19. Disinfectant (Excluding Bio-
compatibility testing) Class B
20. Disposable Perfusion Sets
Class C
21. Disposable Perfusion Sets
(Excluding Biocompatibility
testing) Class C
22. Disposable Hypodermic
Needles (Excluding Bio-
compatibility testing) Class D
23. Surgical Suture Class D
24. Urine collecting bag Class B
25. Surgical Gloves ( Sterile/Non
Sterile) Class D
26. Endotracheal (ET) tube Class B
27. Disposable Hypodermic
Syringes Class C
28. Blood Bag (Single Blood Bag,
Double Blood Bag, Triple
Blood Bag, Quad Blood Bag)
Class C
. Disinfectant (Excluding Bio-
compatibility testing)
Ee Accuprec Research TL/MD/2021/000002 | 1. Vascular devices and IV sets;
Labs Private Limited Class D
Opp. Zydus Pharmez, oO Tubal rings; Class C
| Changodar- Bavla
Copper T; Class C
Sutures; Class C
| Highway, Vill-Matoda,,
Sanand, Ahmedabad,
Disposable Hypodermic
| Gujarat - 382213 needles; Class C
Plo? Catheters; Class D
Disposable Hypodermic
Syringes; Class B
8. Blood bags; Class B
9 Condoms; Class C
10. Coronary stents; Class D
'11. Intra Ocular Lenses Implants;
Class D
12. Orthopaedic Implants and
Devices; Class D
13. Drug eluting stents; Class D
14. Internal Prosthetic
replacements; Class D
| 15. Ablation devices; Class D
i
Page 10 of 11113 | Mls, Conformity | TL/MD/2021/000003 |1.NIBP; Class B
| Testing Labs Pvt Ltd 2.IBP: Class C
WH-52, Mayapuri |3.Nebulizer; Class C
| Industrial Area, Phase |4. Thermometer; Class B
| 1, New Delhi, West 5.Glucometer; Class B
Delhi, Delhi - 110064
/14 | Brothers TL/MD/2021/000004 | 1. Disposable Hypodermic
| Laboratories Pvt. Ltd Needles; Class B
| 103, D-3, Industrial | |2.Surgical Dressings; Class A
Area Jhotwara, Jaipur, 3. Disposable perfusion set; Class B
| Rajasthan - 302012 4. Catheters: Class B
| | 5. Surgical Dressings; Class B
| 6. Disinfectants; Class B
| _7.Disposable Hypodermic
__ Syringe; Class B
'8.1V Canulae; Class B
|9.Scalp Vein Set; Class B
Ne
ae
py
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
IT Cell for uploading the information on the CDSCO website.
Page 11 of 11