ICMR Survey

ICMR Survey on Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program

Request for Participation In ICMR’s Landscape Study For Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program of Medical Device and Diagnostics Mission Secretariat, ICMR

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation,
coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.

ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical
research on the one hand and to the need of finding practical solutions to the health problems of the country,
on the other.

The Indian Medical device market is currently valued at USD 11.2 billion and is experiencing a growth rate
of 15% CAGR as against growth rates observed by developed countries of about 4% CAGR. India is
dependent on imports for its medical device needs with 80% of medical devices being imported. In view of
the huge import, dependency and long technology development cycle of medical devices, there is an urgent
need for providing holistic support across the medical device development and commercialisation cycle
including R&D, scale-up, validation, regulatory compliance, market access etc.

To cater to the above challenges, ICMR has established Medical Device and Diagnostics Mission Secretariat
(MDMS) with a vision to support and catalyze research, development and indigenous manufacturing of cost effective medical devices to strengthen health care sector in India and reduce import dependency through a Mission mode consortia approach. ICMR-MDMS aims to conduct a multipronged landscape study inviting medical professionals working at both Government and Private Institutes to provide their opinion on the medical device and diagnostic products as they are the Key Opinion Leaders and the end users of the
products.

The objectives of the study are:

(i) To identify various medical devices/sub-sectors/verticals based on unmet healthcare needs and
contribute to import dependency in the Country with inherent potential for societal impact.
(ii) To strategize, categorize, prioritize, and plan devices/sub-sectors/verticals for extending funding
support in a phased manner initially focussing on low end devices, which can deliver volumes and then
graduating to high end devices as the program progresses, for accelerating unmet need driven devices
and diagnostics product development for wide societal impact.
Medical professionals in both Government and private medical colleges/ institution are requested to fill the
virtual survey form. The form can be accessed through the link given below. A guidance document is also
enclosed for your kind perusal for assisting in filling up the form.

Link for the Medical Device form : http://103.25.130.160/icmr-survey/
Link for Invitro Diagnostic Devices Form: http://103.25.130.160/icmr-survey/niform.php

Date of Submission:
Start Date: 3rd Feb’ 2022 Time: 09:00 AM
End Date: 25th Feb’20202 Time: 05:00 PM

In case of any query you may contact the following officials:
Medical Device and Diagnostics Mission Secretariat (MDMS)
Indian Council of Medical Research
Ansari Nagar, New Delhi- 110029
Email: suchita.markan@icmr.gov.in,
icmrmdmsoffice@gmail.com,
div.itr.icmr@gmail.com
Telephone No.: +91-11-26588895 Ext-337

Source : https://main.icmr.nic.in/sites/default/files/whats_new/Landscape_participation_request_03022022_1.pdf

Technology Transfer Call

Expression of Interest For Transfer of Technology from CDAC

Announcement from CDAC – CENTRE FOR DEVELOPMENT OF ADVANCED COMPUTING

Centre for Development of Advanced Computing (C-DAC) is the premier R&D organization of Ministry of  Electronics& Information Technology (Meity) for carrying out R&D in IT, Electronics and associated areas. More details about C-DAC can be found at www.cdac.in

CDAC, Mohali, originally established as CEDTI (Center for Electronics Design & Technology of India) in the year 1989 is a leading organization of the Ministry of Electronics and IT, Govt. of India for electronics and related technologies. The electronics section has executed several Govt. Of India projects in fields of medical and agriculture. A few products / technologies developed during the course of different projects / initiatives have been refined are being offered for ‘Transfer of technology’. At this point of time, the following products are offered on a non-exclusive basis. After due process as per the CDAC’s ToT policy, the successful bidder shall be provided full technical support to productionise and market the products in Indian markets as per the applicable norms. 

  1. Mini Hydroponics system &
  2. Wireless auscultation training system
  3. MK-1ARS

The technology will be transferred on non-exclusive basis. 

      The procedure shall involve the following steps – 

  1. Call for Expression of interest. The interested Organizations/Entrepreneurs/Agencies can inspect the prototype of the product at CDAC Mohali, before submitting their sealed bid of EoI
  2. The TOT committee will analyze received EoI’s on the basis of Technical and financial position, capability and reputation of the applicants. The short listed applicants shall be asked for submission of their sealed best price (financial) bids.
  3. TOT Committee will do the screening and issue offer letters for TOT to one or more applicants based on highest bid or higher than the certain minimum fixed by the empowered authority. 
  4. The selected Organizations/Entrepreneurs/Agencies will pay the TOT fees and sign the agreement for TOT.CDAC will then transfer the technology, hand over all the supporting documents and will provide full technical support and training to the TOT partner.

The ToT package shall contain the following 

  1. Document(s) for design and fabrication with block diagram and schematic level explanation of the system.
  2. Bill of Materials of the total system.
  3. Gerber files for PCB design.
  4. Source code of the software.
  5. Test plan and procedure.
  6. Guidelines for field trial and commissioning.
  7. Training.
  8. Handholding support for a period of 6 months.

General terms & conditions 

  1. The last date for receipt of EoI in the attached template (format) is 6 pm. of  31st  January , 2022. 
  2. This transfer of technology shall be on a non-exclusive basis. 
  3. An expert committee will scrutinize the applications for follow-up action. The applicants may be called for a presentation regarding their strengths and business proposals. 
  4. All incidental expenditure incurred in preparation/ submission or presentation of the EoI shall be borne by the participating Organizations/Entrepreneurs/Agencies.
  5. Participation in this EoI does not guarantee any association with C-DAC unless notified by C-DAC in writing. 
  6. C-DAC reserves the right of rejecting any offer without assigning reasons. 
  7. Any offer received after due date/time will not be accepted. 
  8. There is neither a business guarantee nor any commitment for funding support from C-DAC to the appointed/ Empanelled agencies. 
  9. A Committee of experts constituted by the competent authority (Director General, CDAC in congruence with Executive Director, CDAC Mohali) will assess capabilities and strengths of the applicant/industry before finalizing the TOT. The minimum turnover of the organization in last three years and/or the manufacturing capabilities may be fixed as one of the eligibility criteria for short listing o f the applicants. 
  10. The shortlisted applicants shall then be invited for financial bidding. C-DAC Mohali reserves the right for asking security fee. Based on value quoted and subject to minimum fixed by committee; one or more of the applicants shall be selected for TOT. 
  11. The selected applicant willing to take technology for commercial exploitation will be required to enter into a ToT agreement with C-DAC as per the terms and conditions approved by the competent authority for the purpose. 
  12. The decision of the committee/ Director General, C-DAC / Executive Director C-DAC, Mohali shall be binding on all concerned. 

Who can apply? 

•Organizations/Entrepreneurs/Agencies with experience or interest in Electronics or Information    and Communications Technology (ICT) 

•Organizations/Entrepreneurs/Agencies willing to take up the local production and    manufacturing of Electronic Stethoscope.

How to apply? 

Interested Organizations/Entrepreneurs/Agencies may send expression of interest with their details by filling the questionnaire as per Annexure – A along with supporting documents to following address. 

The participants may then be asked for financial bidding for the transfer of technology. 

Executive Director  
Centre for Development of Advanced Computing (C-DAC) 
A 34, Phase VIII Industrial  Area, Mohali(Near Chandigarh)Punjab ,INDIA
Phone: +91-172-6619000, 2237052-57
Fax: +91-172-2237050-51

Note: For any queries please contact : 
Ms. Brijinder Kaur Tel: + 91-172-6619073, 
Email: brijinder@cdac.in

Download the EoI Document here for more detailed information :

Source : https://www.cdac.in/index.aspx?id=pdf_inviting_EoI_website_banner_F

Indian Made Omicron Test Kit

Tata Medical and Diagnostics has developed a kit “OmiSure” for detecting Omicron variants in RT-PCR Tests

Tata Medical and Diagnostics has developed a kit called “OmiSure” that can detect Omicron variants of SARS-CoV2 in nasopharyngeal / oropharyngeal specimens during RT-PCR testing. As per the company’s press release, the test kit is compatible with all standard real-time PCR machines. This kit can detect Omicron variants as well as other variants of SARS-CoV2 reported so far.

Currently, patients with Omicron are detected only after genomic sequencing. This test helped eliminate that step and could make detections during the test. The kit was developed to detect new variants of SARS-CoV2 directly and very specifically. Head of Research and Development , TATAMD said the first target is based on the S gene dropout or S gene target disorder (SGTF) and the second target is based on the S gene mutation amplification (SGMA). The Indian Council of Medical Research (ICMR) has approved the kit.

Presently, the Omicron variant is being detected using test kits developed by US-based Thermo Fisher which uses S-Gene Target Failure (SGTF) technology, which is also used by OmiSure.

In its letter approving the kit, the ICMR stated: “The tests have been performed as per the manufacturer’s instructions. Responsibility for batch-to-batch consistency lies with the manufacturer.”

The company had applied for a license with the Central Drugs Standard Control Organization (CDSCO). The kit will be manufactured by TATAMD at the Sriperumbudur facility in Tamil Nadu once the license is approved by the CDSCO. The company currently has daily capacity of 2,000,000 kits and plan to increase the capacity from 5,000,000 to 10,00,000 by the third week of January. The kits are manufactured in both the domestic and international markets. The company also applied for a patent for this kit .

Download the ICMR Approval here

Source

https://indianewsrepublic.com/tata-medical-and-diagnostics-has-developed-a-kit-omisure-for-detecting-omicron-variants-in-rt-pcr-tests/605532/

https://www.gonewsindia.com/latest-headlines/icmr-approves-first-rt-pcr-kit-to-detect-omicron-variant-by-tata-named-omisure-11809

https://www.icmr.gov.in/ckitevaluation.html

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

DoP Announcement

DoP Announcement – Call for Updating, Listing of Domestic Manufacturers in India

Announcement from DoP to Local Manufacturers of Specific Medical Devices / Equipment

ANNEXURE – I

This Annexure contains the list of Medical Devices/Equipment, for which, the details of local manufacturers are not available, as per the details collated from the Domestic

Medical Device manufacturing Associations such as AiMED & ADMI and KIHT (based on the details of medical devices, as furnished by the procuring agencies)

LIST-1 of 128 Medical Devices/Equipment

S.No.                                               Name of Medical Device/Equipment
1Intra-aortic balloon Pump (IABP)
2Video Assisted Thoracic Surgery (VATS) and Minimally Invasive Cardiac Surgery instrument set
3Flow Track Cardiac Output Monitoring (EV1000)
4Sander’s Jet Ventilator for Emergency Airway
5ENT Coblator system with standard set of wands
6Automated Identification and antibiotic susceptibly system  
7Automated Semen Analyzer
8Histopathology fully automated H& E slide Stainer
9Fully Automated IHC Stainer
10Auto PAP cervical cancer screening system with HPV
11Automatic components preparation machine
12Visual Field Analyzer
13Cystoscope paediatric cystoscope
14Flow Cytometer
15Flexible cysto-nephoscopy
16T Piece Resuscitator
17CO2 Fraction Laser
18Diode Laser
19Q-Switched ND YAD Laser
20Video Bronchoscope set Adult, Paediatric, and Neonatal
21Surgical Operating Microscope
22Cavitational /Cavitron – Ultrasonic Surgical Aspirator (CUSA)
23Endobronchial Ultrasound System
24Rotary Microtome
25Magnifying surgical loups
26Endoscopic Saphenous Vein Harvesting (EVH) System
27Intra operative Imaging and TTFM for CT Surgery
28DEXA Scan
29Radio surgery equipment
30Near Infrared Spectroscopy
31Fluid therapy  
32Near Infrared Spectrometer (NIRS)
33Electro Physiology (EP) System
34TOF Monitor/Watch for Neuro Muscular block
35Transcranial Doppler
36Low Temperature Hydrogen Peroxide Gas Steriliser  
37Mannequins (Laerdal) for training of CPR for COVID Preparedness
a) Intubation
b) Cardio Pulmonary Resuscitation (CPR)
c) Peripheral, Central and Arterial Cannulation
d) Front of neck Access (Cricothyroidotomy and tracheostomy)
38Image Analysis Tools/ Trinocular Compound Phase Contrast Microscope for Andrology Lab  
39Gas Analysis Apparatus Halden’s Student Type
40Gas Analyzer Automatic for CO2, O2 and N2
41High end Operating Microscope
42Plasma Coblation System
43Stroboscope
44ENT Skull Base Navigation System
45Automated Microbial Identification and Sensitivity System
46NAT Analyzer
47Cryostat
48Vitek2-Automated Microbiology Susceptibility Testing Analyser
49FFR Machine (Fractional Flow Reserve)
50VIDAS
51Kingfisher Flex
52ACL Elite
53Cytoprep Centrifuge with Vortex Mixer
54Antigen Retrieval System
55Trans Oesophageal Echo Cardiograph
56IVUS –Volcano
57STERRAD -100 NX All Clear
58Minimally Invasive Cardiac Instruments
59Impella
60Endourology set
61Cystoscope Karl Storz
62Video Endoscopy Systems
63Floppy wire with extra support 0 Coronary Angioplasty
64Fully Automated Non-Contact Tonometer
65Optical Biometer
66Phaco Machine with Posterior and Anterior Vitrectomy
67Portable Ultrasound Machine for Anaesthesia and Vascular Access
68Activated Clotting Time Machine
69Thromboelastogram (TEG)/ Thromboelastometer/ ROTEM
70Bone Anchored Hearing Aid (BAHA) Sound Processor with Soft Band.
71CI Speech Processor for Cochlear Implant   
72Bi-Ventricular Pacemaker with Quadripolar LV Lead
73DDDR with Matching Electrodes Pacemaker
74MRI Conditional Automatic Implantable Cardioverter Defibrillator (AICD)
75MRI Conditional Cardiac Resynchronisation Therapy – Pacing (CRT- P)
76Single Chamber (SSI) MRI Compatible Pacemaker
77Single Chamber Temporary Pacemaker
78Non-complain /semi complain /CTO coronary balloon.  
79Vacuum Heart Stabilizer System for off Pump CABG
80Expandable Corpectomy device
81Biomimetic Synthetic Absorbable Dural substitute of sizes
82AO TRS Modular Drive for Drill/Reamer
83AO TRS Modular Sagittal saw system
84Battery Oscillator
85Arthroscopy Systems
86Navigation System for Neurosurgery & Orthopaedic Surgery
87Time Lapse Embryo Imaging System
88Portable Mobile Endoscopy Unit
89Cryoprobe  
90Isothermal Calorimeter (ITC)
91Electrical Impedance Tomography  
92FNIRS (Functional Near Infra-Red Spectroscopy) System  
93Automated Hand-Held Analyzer  
94Automated High Throughput Liquid Based Cytology (LBC) System  
95Automated IHC (lmmunoHistochemistryStainer)  
96Automated Slide Stainer for Histopathology
973T Digital PET/MR  
98Dual Particle Cyclotron on buyback basis  
99Sweat Collection and Chloride Estimation  
100Automated Bronchoscope Cleaning Equipment  
101Electronics and console for the existing 700 MHz NMR Spectrometer  
102Video bronchoscope with mobility of tip in four directions  
103Freeze Facture System  
104Cryo Plunge Freezing Unit  
105Biological High- Resolution Atomic Force Microscopy  
106Carbon Coater (Evaporator) for grids
107HemostasisAnalyzer System  
108Auricular Reconstruction Set  
109Thin Layer Chromatography Liner Analyser for lipid analysis  
110Digital Slide Scanner System  
111Full Endoscopic lumbar IT & ED set  
112Rapid Blood/Fluid Flow warmer  
113Fully Automated Computerized Archival System for Histopathology & Cytology Slides  
114Vacuum Assist Drainage Controller Device  
115VAP Care System  
116Cryoablation Unit  
1173D Printer Hardware with SLA (LFS) TM Technology and Machine interface software  
118Transcutaneous Oxygen Monitor  
119Non-Invasive Jugular Oximetry Monitor  
120Dedicated Solid-state cardiac SPECT Camera
121Hemodynamic Recorded for Cardio Vascular Lab  
122Gel Documentation System  
123Automatic Colony Counter
124Droplet Digital Polymerase Chain Reaction System (PCR)  
125Multi-block PCR Machine
126Integrated Automated Charting System upgradable for ICU Monitoring System  
127Viscoelastic Global coagulation Testing Device  
128Robotic Surgery System with accessories  

LIST – 2 of 365 Medical Devices/Equipment

S.NoName of Medical Device/Equipment
13 feet IVF workstation with stereo microscope & camera
2384 well block, 96-well block and open array real-time PCR system
34D Echo Cardiography
4532 nm Green Laser Console
5Advanced Flow Cytometer
6Advanced High Energy Linear Accelerator (LA) System
7Agarose Gel Electrophoresis System
8Air Particle Counter
9Ambulatory blood pressure Monitor Continuous Glucose Monitoring System
10Anaerobic work station with gas cylinder complete
11Animal Stimulator Software for Pharmacology
12Antibiotic Zone Reader
13Apheresis Machine
14ATLS Practising Manikin
15Atomic absorption Spectrophotometer (AAS) with hydride generator
16AutorefractorKeratometer
17Autoanalyzer immunoassay (chemiluminescence based) – fully automated with UPS back up
18Automated bacterial identification system
19Automated Capillary DNA Sequencer
20Automated Cell Viability Analyser with computer, printer and UPS
21Automated Clinical Electrophoresis
22Automated continuous monitoring standalone blood culture system
23Automated Coverslipper
24Automated digital slide scanner
25Automated liquid handling system for Serial Dilutions
26Automated Microbial Identification and Antimicrobial Susceptibility Testing System
27Automated Nucleic Acid Purification system (96 well)   
28Automated Perimeter
29Automated Protein Purification System (FPLC)-
30Automated rapid T.B culture and drug sensitivity detection system for 960 samples
31Automated Real Time qPCR with four sample modules
32Automated Slide Stainer
33Automated Tissue Microarrayer & TMA Software
34Automated Urine Analyser
35Automated Vascular Doppler Recorder for ABI/TBI/Segmental Pressure
36Automatic Chemistry Analyzer
37Basic Transcranial Magnetic Stimulator
38Battery operated drills
39Bench top flow cytometer
40Bench Top Fourier Transform NMR System (Lower version)
41BERA with ASSR
42Bio-Fermenter 25-50L
43Biplane DSA
44Bipolar Resectoscope with Microprocessor Controlled Electrosurgical Unit
45Blood & Fluid Warmer HL 90 (PAC)
46Blood & Fluid Warming Device
47Blood Bank Management System Using RFID Technology (PAC) (Biolog-id)
48Blood Gas Analyser
49BLS Practising Manikin
50Body Plethysmograph with Diffusion Study
51bone filler device
52Bronchoscopy/Oesophagoscope
53Cardiac autonomic neuropathy analyser
54Cardiopulmonary Bypass Machine
55Cardiotocography Machine
56C-arm Image Intensifier with DSA and Radiolucent Table
57Cartridge base nucleic acid amplification system (CBNAAT)-16 cartridge module
58CATH Lab including All accessories and EP
59CELL COUNTER (3 PART DIFF.)
60Cell Counter (6 parts)
61Cell Morphology Biosensor
62Cell Saver
63Chemiluminescence & Gel imaging & analysis system
64Chemiluminescence enzyme immunoassay processing system (CLEIA)
65Chemiluminescence and fluorescence doc imaging system (chemidoc imaging system)
66CHNS Analyzer
67Close Sterility Test System
68CO2 Laser
69Coaxial Ophthalmoscope Rechargeable
70Colour Doppler
71Colour Doppler (2D & 3D)
72Colour Doppler 4D
73Colour Doppler with all general-purpose probes
74Combined Ultrasonic Cutting, Coagulation & Vessel sealing System
75Complete Chromatographic Unit for paper & TLC
76Computer Assisted Semen Analyzer
77Computerized Biofeedback Machine
78Cone Beam Computed Tomography
79Continuous Glucose Monitoring System
80CR System
81Cranial Stabilization system
82CRRT Machine
83Cryo -Microtome (1 in class B)
84Cryo Surgical System
85Cryotherapy
86CT 128 Slice
87CT 256 Slice
88CT Simulator System
89Cyclotron
90Cystoscope-resectoscope-VIU-Cystolithotripsy-TURis Adult set
91Densitometer with computer
92Derma scope
93DEXA Scanner (BMD)
94Difficult Airway management simulator
95Digital Colorimeters
96Digital Fundus Camera
97Digital Non-Mydriatic Fundus Camera
98Digital Polarimeter Multi wavelength with printer
99Digital Refractor Meter
100Digital Slide Scanning System with Research Grade Microscope and Image Analysis Software
101Disintegration Test Equipment (1 basket for 6 tablets)
102Dissolution Apparatus
103Dissolution Apparatus with Auto Sampler
104Dissolution media preparation and delivery system
105DNA Sequencer (24 Capillary) +Computer
106DNA Sequencer (96 Capillary) +Computer
107Double beam UV spectrophotometer (UV-Vis, variable wavelength, glass and quartz cuvettes with data analysis software and computer interface and power back-up)
108Double door autoclave 200 L
109Drug Discovery Suite
110Dual action Ultrasonic plus Pneumatic lithotripter
111ECHO and USG Machine
112Echocardiography 2D machine
113Elbow & Ankle Arthroscopy
114Electro Convulsive Therapy (ECT) machine
115Electrohydraulic Urology operation theatre tables
116Electrolyte analyser
117Electron Microscope
118Electronic Blood Cell Counter with six-part differential
119Elevated grossing station
120ELISA (Demonstration)
121Elisa reader with washer and shaker
122Elispot Reader
123Embryonic/Foetal development model
124Endomotor – Endodontic Electric Motor
125Endoscopic sinus surgery set Xenon head light with camera system
126Endoscopic Ultrasound
127ENT Operating Microscope
128ENT Workstation
129ESWL
130ETO machine 100 lit
131ETO Sterilizer
132Excimer Coronary laser Atherectomy System with Catheter (50)
133Fenestrated adapter
134Fibre Optic Light Source
135Fibreoptic bronchoscope with monitor and recording facility for adult and paediatric
136Fibre-optic Video Bronchoscope
137Fibro Scan
138Flexible rhino-pharyngo-laryngoscope
139Flow cytometry with Cell Sorter
140Fourier-Transform Infrared Spectroscopy
141Fragment Analyser/On Chip Electrophoresis Devices
142FT-Infrared Spectrophotometer with ATR and Pellet Press
143FT-Infrared Spectrophotometer with Pellet Press
144FTIR with ATR Arrangement
145Full body pregnancy simulator
146Full size Inhalation Exposure System
147Fully Automated Cell Counter (3 part)
148Fully Automated Coagulometer
149Fully automated Gel Documentation system with UPS back up
150Fully Automated Haemoglobin HPLC System (Model: Variant II Haemoglobin Testing System) (PAC)
151Fully Automated Multiplex Film Array Syndromic System (Model: Film Array TORCH 2.0)  
152Fully Automated Rotary Microtome with accessories
153Gamma Camera
154GAS Chromatography – Mass Spectrometer with flame Ionization detector (GC-MS with FID)
155GC- Electron capture detector (ECD)
156GC- Flame Ionization detector (FID&NPD)
157GC/MS
158GC-HS
159GC-HS with FID detector
160GCMS-MS (QQQ) with HS
161Gel electrophoresis horizontal with compatible power pack and accessories
162GLC with Head Space
163Gluteal IM Injection model
164Gradient PCR Machine
165Gradient Thermal Cycler with standalone UPS
166Grossing Station
167Hand foot UV phototherapy device
168Hand held Doppler (vascular)
169Handheld ICG Fluorescence Imaging System (Burns and Plastic Surgery Block)
170Harmonic scalpel
171HDR Brachytherapy
172Hemo Analyser
173Haemodialysis Machine with SLED
174High Content Screening System
175High Dimensional Flow Cytometry Analyser
176High End Virtual Simulator for Intraocular Surgery Training (Eyes Surgical; Simulator-VR Magic) (PAC)
177High Performance Liquid Chromatography – Analytical with Auto Injector
178High performance Thin Layer chromatography (HPTLC)
179High Resolution GCMS /MS
180High Resolution Manometry  
181High Resolution Orbitrap Mass Spectrometer
182High Through put Real Time PCR
183High throughput single cell analysis system
184High-Performance Liquid Chromatograph with PDA/DAD/RI/FLD
185High-Performance Liquid Chromatograph with PDA/RI/FLD
186High-Performance Liquid Chromatograph with Ultraviolet Detector/High-Performance Liquid Chromatograph with UV Detector
187High-Performance Liquid Chromatography- Analytical with auto injector
188High-Performance Thin-Layer Chromatography
189High-Performance Thin-Layer Chromatography (HP TLC)-MS
190Holmium Laser 100W
191Holmium LASER System with MOSES Technology (Lumenis Pulse 120H) (PAC)
192Holter monitor  
193HPLC based automated analyser for HbA1c & hemoglobinopathy testing
194HPLC based automated analyser for HbA1C testing
195HPLC Preparative (Lower Version)
196HPLC system
197HPLC system for haemoglobin analysis
198HPLC with fraction collector
199HPLC-ICP/MS
200HPTLC with MS
201Hydrogen Peroxide Decontamination System
202Hyperthermic Intra Vesicular Therapy (Combat BRS Recirculating Fluid Warming System) (PAC)
203ICP Monitor
204ICP MS
205IHC Immunostainer
206Ilizarov Instrumentation Set Complete with Accessories as
207Image analyser cum viral foci counter
208Immunoanalyser (Chemiluminescence based) fully automated with UPS back up
209In vivo Animal imaging System
210Incinerator
211Individually ventilated cages/housing system for small animals
212Infant Multipurpose Resuscitator cum Operating Beds
213Intense Pulse Light Device
214Intra Operative Nerve Monitoring
215Invasive BP Monitoring System
216Inverted Fluorescent Microscope with Live Cell Imaging Capability
217Inverted Trinocular Epifluorescence Microscope with Imaging system
218Ion Chromatograph
219IPL (Intense Pulse Light System)
220IUD insertion trainer uterus
221Karl Fischer Titrator (Semi-Micro Determination of Water)
222Laparoscopic Surgery set with High-Definition camera
223Laparoscopic Surgery Set with Hysteroscope & resectoscope with High-Definition Camera & Monitor
224Laser for existing Confocal Microscope
225Lasik Machine
226LCMS
227LCMS MS
228LC-MS/MS (QQQ)
229LEEP System with Smoke Evacuator & integrated cart
230Leyla Retractor System
231Life Port Kidney Transporter With 05 Sets of Expendables with Each Equipment (PAC)
232Liquid Based Cytology System
233Liquid Particle Counter
234Low Energy Linear Accelerator (LA) System
235Lymphovascular Microscope
236Magnetic Bead based Multiplex Immunoassay system
237Measurement of Lung clearance index (LCI)
238Medical Thoracoscope (semi rigid)
239Melting- Point Apparatus
240Mercury analyser
241Metaphase Finder System with Fluorescence
242Micro Needling Radio Frequency Equipment
243Microinjection system (Microinjector, Micromanipulator, Pipette puller)
244Micro method bilirubin analyser
245Microplate multimode reader
246Microscope (with Phase Contrast and Camera attachment)
247Microvascular Instruments Set
248Microwave digestion System
249Motor (electric) Dermabrader
250MRI
251MRI 1.5 T
252MRI 3T T
253MSK-USG with linear transducer
254Multimode Microplate Reader and Fluorometer
255Multimode Reader
256Multiplex Protein Array System
257Multiplex Suspension Array System based on xMAP Technology
258Nanobio Spectrophotometer
259NdYag Laser with IPL
260ND Yag Laser(1064nm)
261Nerve stimulator (intra operative)
262Neuro Surgical Drill with all attachments.
263Neuropathy analyser-vibration perception threshold + temperature perception threshold
264Neurosurgery Operating Table with Accessories
265New-born Resuscitation Manikin
266Next Generation Sequencer – Higher Version
267Next Generation Sequencer – Lower Version
268Next generation sequencing machine
269Nursing baby with SimPad/Nursing kid with SimPad system
270OAE (screening)
271Operating Microscope
272Operating Microscope (Plastic Surgery)/Plastic Surgery Operating Microscope
273Ophthalmic Operating Microscope
274Orbitrap Proprietary Mass Spectrometer
275Orthopantomogram (OPG) unit
276Osmometer
277Pacemaker Dual Chamber – External
278Pacemaker Single Chamber – External
279Patient Care Simulator
280Patient Care Simulator with Sim Pad
281Patient warming System
282PCNL set
283Paediatric Bronchoscope set
284Paediatric cystoscope and resectoscope set/Cystoscope & Resectoscope – Paediatric
285Paediatric High Resolution Fibre Flexible Bronchoscope with recorder and Screen Display
286Paediatric laparoscopy set
287Paediatric rigid Esophagoscope
288PET CT
289Phaco Machine
290Physical assessment simulator
291Platform pedography system
292Pneumatic lithotripter
293Point of Care Device for estimation of Cardiac Biomarkers (CKMB, Troponin, BNP, Myoglobin) and PT-INR
294Point of Care Machine (Trop I, BNP, CPK-MB, CRP)
295Polarimeter with Multi Wavelength
296Portable Colour Doppler
297Portable colour doppler with echo probe
298Portable Echocardiography system
299Portable Fluorescence Microscope
300Portable Ultrasound & Colour Doppler
301Potentiometric Titrator with necessary electrode
302Potentiometric Titrimeter
303Power Assisted Liposuction System  
304Power Tools for Craniomaxillofacial and hand surgery (Electric micro drill)
305Powered Liposuction Set
306Preparative floor model refrigerated ultracentrifuge
307Protein purification system
308Pulsed Field Electrophoresis System
309Pure tone Audiometer
310QTOF Mass Spectrometer
311Quaternary FHPLC (Fast High Pressure Liquid Chromatography) with Fluorescence + visible and PDA detectors with columns and autosampler (Inclusive Software programme + computer + printer+ Online UPS with at least 1 hr backup)
312Radiofrequency Generator with integrated vessel sealing and cutting system
313Raman Spectroscope
314Random access medium throughput fully automated chemistry analyser
315Real Time PCR machine with standalone UPS unit
316Realtime PCR based detection system for specialised pathogens & viruses
317Rigid Bronchoscope
318Rigid Thoracoscope (VATS)
319Semi-automated ELISA system with washers
320Semi Rigid Pleurovideoscope
321Shaver System cum micro drill
322Single Channel transcutaneous oxygen monitor
323Single Planar C-Arm Fluoroscope plus DSA with Fluoroscope Compatible OT Table
324Small animal behavioural monitoring, tracking and analysis system with accessories (For safety pharmacology)
325Spectrofluorometer
326Spectrophotometer
327Super Microsurgery System
328Temporary Pace Maker Dual Chamber
329Temporary Pacer
330Texture Analyzer
331Thalassaemia And Hemoglobinopathy Testing/Screening System
332Thermal Cycler
333Tissue Morcellator
334TMT machine
335TOC analyser
336Transcranial Magnetic Stimulator
337Transcutaneous bilirubin analyser
338Transillumination Caries Detector
339Triple Quadrupole Mass Spectrometer
340Tube feeding simulator (NG, OG and PEG)
341Tympanometer
342Ultra-High Performance Liquid Chromatography
343Ultracentrifuge with HEPA filter and necessary rotors
344Ultra-Fast Liquid Chromatography
345Ultrasonic Aspirator
346Ultrasonic cutting and Coagulation device
347Ultrasound (A+B scan)
348Ultrasound machine
349Ultraviolet/ Visible Spectrophotometer
350Uretero-renoscope- Adult
351Uretero-renoscope-Paediatric
352Urodynamic System
353Uroflowmetry
354UV- vis Spectrophotometer
355UV/Visual spectrophotometer
356Vacuum assisted wound closer system
357Vacuum Assisted Tissue Processor
358Venepuncture and injection arm
359Venous Coupler System
360Vertical Gel Electrophoresis Apparatus with Western Blotting Apparatus
361Video Bronchoscopy system
362Video EEG (EEG apparatus 32 channel digital model with Videometery, stimulus evoked response signal
363Western Blot Apparatus with Compatible Power Pack
364Workstation for Multi-PTM analysis (Proteomics)
365XRD

Note: List-1 is based on the details, furnished by procuring agencies, till by November 2021 and the List-2 is based on the further details furnished by procuring agencies subsequently.  

Annexure-II

This Annexure contains the list of Medical Devices/Equipment, with the details of available local manufacturers, as collated from the Domestic Medical Device manufacturing Associations such as AiMED & ADMI and KIHT (based on the details of medical devices, as furnished by the procuring agencies)

List of 237 Medical Devices/Equipment

Note: The details, as received from the Associations, are incomplete and hence, the concerned local manufacturers are requested to give their full details, as requested in the Notice, to the mail id given in the announcement – pppmii-dop@gov.on

Source –https://pharmaceuticals.gov.in/sites/default/files/Request%20for%20local%20manufacturers%20update.pdf

Update from Pharmabiz News

DoP lists around 500 medical devices and equipment for which it could not identify any local manufacturers

Even though the government had way back in 2017 announced preference to Make-in India products under public procurement, the Department of Pharmaceuticals (DoP) has identified around 500 medical devices for which there is no data on the local manufacturers available even after its attempt to collect data from the domestic manufacturers association.

If no information is received till the end of December, the DoP will further proceed with the action, arriving that the local manufacturers are not available for these medical devices. This comes at a time when there has been a huge push towards Make in India projects and domestic industries have been demanding more preference to the local manufacturers.

For another 237 products it was able to collate data from the domestic medical devices manufacturing associations.

The Department of Promotion of Industry and Internal Trade (DPIIT) has issued the Public Procurement (Preference to Make in India) Order, 2017, on September 16, 2020, following which the DoP had issued guidelines on February 16, 2021 for implementation of the Order related to procurement of goods and services in medical devices.

The DoP received various representations from the procuring agencies under the Government of India with regard to non-availability of Class I and Class II suppliers for identified medical devices or equipment. An exercise was done by the Department to ascertain the local manufacturers from different sources for these identified medical devices and equipment, including from the domestic manufacturers association.

“However, recognising that the manufacturers of the identified medical devices may be spread across the country and may not be member of any manufacturers Association and also to give a reasonable opportunity, the said medical devices/equipment, as received from the procurement agencies are being put in public domain to collect details of local manufacturers,” said a latest public notice issued by the DoP.

It has sought details including name of the manufacturing entity, address of registered office and manufacturing location, contact details, email ID and phone numbers, local content percentage of the medical devices, specifications of the medical device equipment and whether it is registered with the government e-Marketplace portal, for smooth implementation of the public procurement policy which gives preference to domestic manufacturers with sufficient local content.

If no information is received in the email-ID provided by the Department latest by December 31, 2021, further action will be taken, arriving that local manufacturers are not available for these medical devices/equipment.

For details of the specifications of the medical devices or equipment in the list, the manufacturer may contact agencies like Central Medical Service Society of Ministry of Health and Family Welfare, Employees State Insurance Corporation of Ministry of Labour, All India Institute of Medical Sciences, New Delhi, Procuring agencies of Ministry of Railways, Director General of Armed Forces Medical Services and HLL Infra Tech Services Ltd of Ministry of Health.

The list 1 of 128 medical devices and equipment for which public procurement agencies were not able to identify local manufacturers include intra-aortic balloon pump, video assisted thoracic surgery and minimally invasive cardiac surgery instrument set, flow track cardiac out monitoring device, ENT Coblator system and standard set of wands, among others. The list 2 of 365 medical devices and equipment include 4D echocardiography, ambulatory blood pressure monitor continuous glucose monitoring system, animal simulator for pharmacology, antibiotic zone reader, blood bank management system using RFID technology, among others. The List 1 was based on details furnished by the procuring agencies till November, 2021 and the List 2 was based on further details submitted subsequently.

Source –  http://www.pharmabiz.com/NewsDetails.aspx?aid=144745&sid=1

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0

Materiovigilance Programme of India

Webinar on Key role of Medical Technology/ Medical Device Industries in Materiovigilance Programme of India

Materiovigilance Programme of India, Indian Pharmacopoeia Commission!    

Program Announcement from IPC

Indian Pharmacopoeia Commission (IPC), an Autonomous Institution of Ministry of Health and Family Welfare, Government of India functions as National Coordination Centre (NCC) for Materiovigilance Programme of India (MvPI) since January 2018 with the primary objective of ensuring patient/user/third party safety from medical devices and IVDs. Materiovigilance Programme of India (MvPI) has the responsibilities to monitor, collate and analyse the adverse event associated with use of medical devices in Indian population and suggesting regulatory bodies to take appropriate action.

NCC-MvPI is jointly organizing a webinar entitled “Key role of medical technology/ medical device industries in Materiovigilance Programme of India” in association with CDSCO and AIMED on December 10, 2021 via digital/virtual platform.

The objective of the webinar is to spread awareness on materiovigilance among marketing authorization holders (MAHs) including Importers, distributors of medical devices and healthcare professionals across India in order to strengthening of the materiovigilance pan India.

In this regard, we are requesting you to participate or kindly nominate officials who are associated with post marketing surveillance of medical devices in your organization. You can also percolate this information to other appropriate organizations so that they will get benefited. We look forward to your support for making this event a grand success.

The necessary information is attached herewith for your reference.

Who should attend ?

Manufacturers, Distributors, Importers, Regulators of medical devices, Healthcare Professionals and Researchers can attend this webinar.

Registration Details :

  • Registration fee: Rs. 7 000 /- (Including 7 8% CST) per participant.
  • Registration maximum for 7 00 participants will be accepted, based on “First come first serve basis”.
  • Payment shall be made by NEFT/Online mode to Indian Pharmacopoeia Commission, Bank of
    Baroda, Sanjay Nagar, Ghaziabad, Bank Account Number: 27 860 7 000 7 3540, Branch IFSC Code: BARBOSANGHA (fifth character is zero), Type of Bank Account: Super Saving, MICR Code of Bank: 7 7007 2204.

Regn Enquiry :
Mr. Maneesh Soni
NCC-MvP1, IPC : +91-9977484175
E-mail: mvpi.ipcindia@gmail.com

For more information:
https://www.ipc.gov.in/news-highlights/904-webinar-on-key-role-of-medical-technology-medical-device-industries-in-materiovigilance-programme-of-india-in-association-of-cdsco-and-aimed.html

Contact :
Dr. Shatrunajay Shukla, Ph.D., M.S. (Pharm.)
Materiovigilance Programme of India (MvPI)
Indian Pharmacopoeia Commission
(Ministry of Health & Family Welfare, Govt. of India)
Sector-23, Raj Nagar, Ghaziabad-201 002, India
Mobile: +91-8840864320,9643460668
(+91)-0120-2800500; 2783400; 2783401
Fax: 0120-2783311
Website: www.ipc.gov.in

Medical Equipment Expo

India International Medical Equipment Expo – Invitation Dec 11th – Dec 13th 2021

Announcement from Andhra Pradesh Medtech Zone

Dr Jitendra Sharma, MD & CEO, AMTZ is inviting you to the IIME Expo, scheduled to happen from the 11-13th Dec 2021 , hosted at Kalam Convention Centre, Vizag, celebrating 3 years of completion of AMTZ.

A unique platform for Medical devices & Equipment manufacturers, Hospital Infrastructure and consumables to meet and network with the Medical Fraternity including Hospital Owners/Management, Consultants, Surgeons & Physicians, Speciality centres etc under one roof.

Exhibitor Product Profile

Profile of exhibit based on Sutures & Sealing Devices, Patient Monitoring Devices, 3D Printers, Machines / Systems, Medical Furniture, Surgical Equipment, Endoscopy Equipment, Dialysis Machines, Lab Equipment, Consumables, Uniforms/Garments, Autoclave, EtO, Drapes, Surgical Equipment, Endoscopy Equipment, Manikins, Gloves, Drug Delivery / Extraction disposables, X-ray, Ultrasound, Digital Imaging, Helicopters & Private Jets, EMS Technology Solutions.

The event will see dignitaries from the Government of India, champions of med-tech, business leaders and hospitals congregating to celebrate our collective success. 

Venue :
India International Medical Equipment Expo 2021
Sat, 11 Dec 2021 – Mon, 13 Dec 2021
Kalam Convention Center
Visakhapatnam, India

Kalam Convention CenterAMTZ Campus, Pragathi Maidan, Siddeswaram, Nadupuru Reserve Forest, Visakhapatnam, Andhra Pradesh 530032

Directions – https://maps.google.com/maps/dir//Kalam+Convention+Center+AMTZ+Campus,+Pragathi+Maidan+Siddeswaram,+Nadupuru+Reserve+Forest+Visakhapatnam,+Andhra+Pradesh+530032/@17.6297358,83.1590403,16z/data=!4m5!4m4!1m0!1m2!1m1!1s0x3a396d5bec015829:0xf36d219478d9473f

Looking forward to seeing you.

Book Your Booth Now : https://lnkd.in/gRAd8rBa

Downloads:

E- Brochure: https://lnkd.in/gZUE2v-H
Floor Lay-out: https://lnkd.in/g8WK3cZq
Branding Opportunities: https://lnkd.in/geXQqNbu

Contact Co-ordinate:

Mr Harish
Director- ICEXPO
+91 8977924225)

World Quality Month Programs

WORLD QUALITY MONTH – INDUSTRY CONNECT KNOWLEDGE SERIES – WEBINARS

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe.

Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Well being is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure Responsible Supply Chain as Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe. 

India too is seeing a huge surge in exports as well as in imports of Products and Services and how do to ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

It is in this context that Consultants Consortium of Chennai (CCC) is rolling out series of Knowledge Sessions to Celebrate the November Month of Quality by connecting Industry and Stakeholders to various sessions which are the need of the hour programs.

CCC has scheduled 6 sessions spread , across the month of November, starting from November 11th 2021 till end of the month. Multiple sessions covering various sectors are scheduled.

CCC will keep communicating and inviting all stakeholders and industry to the sessions. Sessions will have the support of industry, academia, young entrepreneurs, innovators forums and various other stakeholder organizations.

This information is being shared to facilitate industry, academia, startups, Management Systems Consultants and various other stakeholders to register for the sessions . 

Sessions are conducted through Virtual Mode and there is NO REGISTRATION FEE.

SESSION 1 – NOVEMBER 11TH 2021, THURSDAY- 4 :00 PM – 5:30 PM

TOPIC – RESPONSIBLE QUALITY CERTIFICATIONS

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

SESSION 2 – NOVEMBER 13TH 2021, SATURDAY – 4 :00 PM – 5:30 PM

TOPIC – Accessing Global Markets – Role of Private Certifications in Food Sector

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

WORLD QUALITY MONTH SERIES – SUPPORTING BY INDUSTRY ASSNS, CHAMBERS