Must-Have CDSCO License to Manufacture General Hospital and Orthopaedic Instruments in India
Medical devices used in general hospitals and for orthopedics must have a CDSCO license to ensure safety and effectiveness. This is a requirement for manufacturers, suppliers, and distributors of these devices in India. The CDSCO medical device licensing regime is a cornerstone for the healthcare sector and helps to protect patients.
Licensing authorities for General Hospital and Orthopaedic Instruments in India
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Class C and Class D General Hospital and Orthopaedic Instruments and the State Licensing Authority is the licensing authority for Class A and Class B General Hospital and Orthopaedic Instruments in India.
Benefits of CDSCO Medical Device License
A CDSCO medical device license is not just a requirement for manufacturers and suppliers of medical devices. It also offers several benefits to healthcare providers and patients.
- For healthcare providers, a CDSCO license provides assurance that the medical devices they are using are safe and effective. This helps them to provide better quality care to their patients. It also protects them from legal liability in case of any adverse events.
- For patients, a CDSCO license is a guarantee that the medical devices they are receiving are of the highest quality. This helps to reduce the risk of complications and ensures that they have the best possible chance of recovery.
- In addition to these benefits, a CDSCO medical device license also helps to promote transparency and accountability in the healthcare sector. It ensures that all medical devices on the market meet the same high standards of safety and efficacy.
- Overall, a CDSCO medical device license is an important safeguard for both healthcare providers and patients. It helps to ensure that high-quality medical devices are available to everyone in India.
List of “Class A” General Hospital and Orthopaedic Instruments
- Bed exit monitor, Fall prevention
- Stand-on patient scale
- Patient scale
- Clinical color change thermometer.
- Apgar timer.
- Hydraulic adjustable hospital bed.
- Manual adjustable hospital bed.
- Nonpowered flotation therapy mattress.
- Therapeutic medical binder.
- Burn sheet.
- Neonatal eye pad.
- Nipple shield.
- Lamb feeding nipple.
- Suction snakebite kit.
- Therapeutic scrotal support.
- Cardiopulmonary resuscitation board.
- Medical insole.
- Medical examination light, AC powered or Battery
- Skin pressure protectors.
- Body waste receptacle.
- Washers for body waste receptacles.
- Hand-carried stretcher.
- Manual Wheeled stretcher.
- Liquid crystal vein locator.
- Blood bank centrifuge
- Heat-sealing device
- X- ray marker for strut
- Container for orthopaedic cement dispensor
- Box Wrench for Nut/Bolt
- Instrument set for external fixation system
- Spinal cage system instruments
- Cervical plate system instruments
- Mesh system instruments
- Cervical disc spacer instruments for Spine
- Spinal Instrument
- Instrument set for Bone Screws & Plates
- Electronic Drive Instruments & Accessories
- Instrument system for bipolar hip system
- Plaster Instruments/Saw
- Wire tensioner
- Thick /Thin Guide Pin
- Depth Gauge
- Vice Grip
- Bone Tap
- Reamer & its attachment
- Torque Wrench
- Pedical Screw Instruments
- Rod Cutter/Reducer
- Alignment Guide
- Retractor Holder
- Bone Curette
- Bone Cutter
- Surgical Punch/Bone Punch
- Surgical Mallet
- Surgical Spatula
- Surgical Elevator
- Needle Holder
- Tamp, Surgical
- Orthopaedic Countersink
- Periostic elevator
- Pneumatic Tourniquet & its attachment
- Plaster Knife
- Plaster Spreader – Modified & Hanning Type
- Insertion and removal instruments
- Sleeves and its attachment
- Visualization system for arthroscopic and endoscopic procedure
- Bone Chisel
- Dilator & accessories
- Surgical Screw Driver
- Orthopaedic implant impactor
- Adhesive Plaster B.P.’ 88
- Adhesive Tape USP
- Elasticated Cohesive Bandage
- Cotton and Rubber Elastic Bandage
- Cotton Crepe Bandage
- Elastic Adhesive Bandage
- “Extension Plaster –width wise
- Microporous surgical tape
- Orthopedic cast padding
- Plaster of Paris Bandage
- Tearable adhesive plaster
- Skin traction kit
List of “Class B” General Hospital and Orthopaedic Instruments
- Liquid crystal forehead temperature strip
- Electrically powered spinal fluid pressure monitor
- Spinal fluid manometer
- Sterilization process indicator (Biological)
- Sterilization process indicator (Physical/chemical)
- Pediatric medical crib
- Medical bassinet
- Pressure infusor for an I.V. bag
- Intravascular administration set, automated air removal system
- Patient care reverse isolation chamber
- Jet lavage.
- Patient lift, Electrcially powered
- Ultrasonic cleaner for medical instruments.
- Remote Medication Management System.
- Ultraviolet (UV) radiation environmental disinfection device
- Vacuum-powered body fluid suction apparatus
- Sterilization wrap
- Motorised Wheeled stretcher
- Medical washer-disinfector
- Environmental chamber for storage of platelet concentrate
- Blood storage refrigerator
- Electronically operated Tourniquet Single & Double Cuff Consol
- Surgical Drill & its attachment
- Implant Trials
- Computer Assisted Surgery System
- Knee System Instruments
- Hip System Instrument
- Bone cement accessories
- Arthroscopic Instruments
- Shaver System
- Fluid Management System
- Rail Fixation System
- External Ring fixation system
- Six axis correction apparatus with software
- Unilateral External Fixation System
List of “Class C” General Hospital and Orthopaedic Instruments
- Electronic monitor for gravity flow infusion systems
- Ingestible event marker.
- Ultraviolet (UV) radiation chamber disinfection device
- Ethylene oxide gas sterilizer
- Dry-heat sterilizer.
- Steam sterilizer.
- Liquid chemical sterilants/high level disinfectants
- Hydrogen Peroxide Gas Plasma Sterilization System
List of “Class D” General Hospital and Orthopaedic Instruments
- Chemical cold pack snakebite kit.
Are You Looking for CDSCO License to Manufacture and Import General Hospital and Orthopaedic Instruments in India?
Contact MedDev Experts today! We have a team of experienced professionals who can help you navigate the complex regulatory process and get your license approved.
General Hospital and Orthopaedic Instruments Licensing Requirement:
- To manufacture Class A and Class B General Hospital and Orthopaedic Instruments in India, you must obtain the MD 5 License from the State Licensing Authority.
- To manufacture Class C General Hospital and Orthopaedic Instruments in India, you must obtain the MD 9 License from the Central Drugs Standard Control Organization (CDSCO).
- To import General Hospital and Orthopaedic Instruments into India, you must obtain the MD 15 Import License from the CDSCO.
Requirements for Manufacturing, Importing, and Distributing General Hospital and Orthopaedic Instruments in India
License Fee for General Hospital and Orthopaedic Instruments in India
- Class A or Class B: ₹ 5,000/- for manufacturing license, ₹ 500/- for each distinct device.
- Class C or Class D: ₹ 50,000/- for manufacturing license, ₹ 1,000/- for each distinct device.
Validity of General Hospital and Orthopaedic Instruments License in India
- General Hospital and Orthopaedic Instrument licenses are valid indefinitely, as long as the retention fee is paid every 5 years.
How to Apply Online for General Hospital and Orthopaedic Instruments Manufacturing or Import License in India
- Step 1: Enroll your organization on CDSCO’s SUGAM Portal.
- Step 2: Fill in the respective applications and submit them through CDSCO’s online SUGAM Portal.
- Step 3: Upload the necessary documents and make the required payment.
- Step 4: Your application will be scrutinized by the CDSCO Team. If it meets the requirements, it will proceed to a quality management system compliance audit.
- Step 5: The Team will conduct an audit at your manufacturing premises. If any Non-Conformance (NC) is identified, you will be required to submit an NC closure report.
- Step 6: Once all the conditions are met, CDSCO will grant the license.
Deadline for Obtaining General Hospital and Orthopaedic Instruments Licenses in India
The deadline for obtaining General Hospital and Orthopaedic Instruments licenses in India is October 1, 2022 for Class A and Class B devices, and September 30, 2023 for Class C and Class D devices.
List of Documents for Obtaining a General Hospital and Orthopaedic Instruments Manufacturing Licenses in India
- Organization identity proof: This could be the Memorandum of Association, List of Directors or Partners, UDYAM Aadhar, or PAN card.
- Sale Deed / Rent Deed of the Premises: This document proves that you have legal ownership of the premises where you will be manufacturing the medical devices.
- Plant or Site Master File: This file contains information about the layout of your manufacturing facility, as well as the equipment and processes you will be using.
- Building Layout with Dimension: This is a detailed drawing of your manufacturing facility, showing the dimensions of each room and the location of all equipment.
- ISO 13485 Certificate and Previous Audit Reports: This certificate shows that your manufacturing facility meets international standards for quality management systems.
- Competent Technical Staff for Manufacturing and Testing of Devices: You must have a team of qualified and experienced staff who can manufacture and test your medical devices.
- Device Master File: This file contains detailed information about each medical device you will be manufacturing, including its design, manufacturing process, and testing procedures.
- Test License, if any: If you need a license to test your medical devices, you must obtain it before you can start manufacturing them.
- Compliance with the environmental requirements: You must comply with all applicable environmental regulations, such as those related to cleanrooms for manufacturing the devices.
- Certificate of Analysis of 3 Consecutive Batches: This certificate shows that the first 3 batches of medical devices you manufactured meet the required quality standards.