To ensure safety and effectiveness Medical devices used in general hospitals for orthopaedics must have a CDSCO license to manufacture hospital and orthopaedic instruments. This is an essential requirement for these devices’ manufacturers, suppliers, and distributors in India. For the healthcare sector and helps to protect patients the CDSCO medical device licensing regime is a cornerstone.

Who Issues License For General Hospital And Orthopaedic Instruments?

Licensing Authorities For CDSCO License To Manufacture General Hospital And Orthopaedic Instruments are followed by:-

• The licensing authority for Class C and Class D General Hospital and Orthopaedic Instruments: the Central Drugs Standard Control Organization (CDSCO).
• The licensing authority for Class A and Class B General Hospital and Orthopaedic Instruments: the State Licensing Authority in India.

How Hospital and Orthopaedic Instruments are Classified?

As we all know medical devices are classified into 4 categories according to there risk factors. So, if you are dealing in orthopaedic instruments then first you have to figure out in which category your product fits. Below you will get to know about the list of medical devices Class A, Class B, Class C & Class D. Explore it & find your medical device.

Class A General Hospital And Orthopaedic Instruments

The mentioned list of Class A contains all the orthopaedic & hospital instruments that are covered under the lower risk to a minimum as follow:

Class B General Hospital And Orthopaedic Instruments

The following devices are Class B general hospital and orthopaedic instruments that contain the Moderate risk:

• Arthroscopic Instruments
• Arthroscopes
• Blood storage refrigerator
• Bone cement accessories
• Computer Assisted Surgery System
• Electrically powered spinal fluid pressure monitor
• Electronically operated Tourniquet Single & Double Cuff Console
• Environmental chamber for storage of platelet concentrate
• External Ring fixation system
• Fluid Management System
• Hip System Instrument
• Implant Trials
• Intravascular administration set, automated air removal system
• Jet lavage
• Knee System Instruments
• Liquid crystal forehead temperature strip
• Medical bassinet
• Medical washer-disinfector
• Motorized Wheeled stretcher
• Pediatric medical crib
• Patient care reverse isolation chamber
• Patient lift, Electrically powered
• Pressure infusor for an I.V. bag
• Rail Fixation System
• Remote Medication Management System
• Shaver System
• Six axis correction apparatus with software
• Spinal fluid manometer
• Sterilization process indicator (Biological)
• Sterilization process indicator (Physical/chemical)
• Sterilization wrap
• Surgical Drill & its attachment
• Ultrasonic cleaner for medical instruments
• Ultraviolet (UV) radiation environmental disinfection device
• Unilateral External Fixation System
• Vacuum-powered body fluid suction apparatus

Class C General Hospital And Orthopaedic Instruments

The following devices are Class C general hospital and orthopaedic instruments moderate to high:

• Dry-heat sterilizer.
• Electronic monitor for gravity flow infusion systems.
• Ethylene oxide gas sterilizer.
• Hydrogen Peroxide Gas Plasma Sterilization System.
• Ingestible event marker.
• Liquid chemical sterilants/high-level disinfectants.
• Steam sterilizer.
• Ultraviolet (UV) radiation chamber disinfection device

Class D General Hospital And Orthopaedic Instruments

The following devices are Class D high-risk general hospital and orthopaedic instruments:

• Chemical cold pack snakebite kit.

What Is The General Hospital And Orthopaedic Instruments Licensing Requirement?

• You must get the MD 5 License from the State Licensing Authority to manufacture Class A and Class B General Hospital and Orthopaedic Instruments in India.
• You must get the MD 9 License from the Central Drugs Standard Control Organization (CDSCO) to manufacture Class C General Hospital and Orthopaedic Instruments in India.
• You must get the MD 15 Import License from the CDSCO to import General Hospital and Orthopaedic Instruments into India. These all are the requirements for CDSCO License To Manufacture General Hospital And Orthopaedic Instruments

Which Form Required for General Hospital And Orthopaedic Instruments License?

If you are dealing in General hospital & orthopaedic instruments for manufacturing, importing or distributing then you must understand regulatory compliance standards. The following form is a must to obtain the license:

• Form MD 5

The license is issued by the State Licensing Authority for Class A & Class B Devices. this application typically covers all the devices that comes under low to moderate risk. And obtaining this form is necessary for the legal production and distribution of these products.

• Form MD 9

This license is issued by the CDSCO (Central Drugs Standard Control Organization). It is mandatory for the Class C and Class D medical device. These classes inducles the higher risk and crucial to obtain to make your product legal and seamless distribution.

• Form MD 15 Import

If you are an importer of this product then you must apply for a medical import license. It ensures that imported devices meet Indian regulatory requirements and are safe for use in the healthcare system. It is also issued by the CDSCO.

Manufacturing License Fee For General Hospital And Orthopaedic Instruments 

The cost of a license for manufacturing is ₹ 5,000/- only for Class A or Class B and ₹ 500/- only for each distinct device. The cost of a license for manufacturing is ₹ 50,000/- only for Class C or Class D and ₹ 1,000/- only for each distinct device.

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Validity Of General Hospital And Orthopaedic Instruments Manufacturing License 

The manufacturing Licenses of General Hospital and Orthopaedic Instrument are valid indefinitely, the renewal fee must paid for every 5 years.

Procedure To Apply Online For General Hospital And Orthopaedic Instruments Manufacturing Or Import License

Steps to obtain a CDSCO License To Manufacture General Hospital And Orthopaedic Instruments are given below:-

• Step 1: On CDSCO’s SUGAM Portal you need to Enroll your organization.
• Step 2: Fill out the respective forms of applications and submit them via the CDSCO’s online SUGAM Portal. 
• Step 3: Upload all the required documents and then make payment.
• Step 4: The CDSCO Team will scrutinize your application. If it meets all the requirements of CDSCO, it will further proceed to a quality management system compliance audit.
• Step 5: An audit will conducted by the Team at your manufacturing premises. If the team identifies any Non-Conformance (NC), you will need to submit an NC closure report.
• Step 6: Once all the requirements are meet, CDSCO will grant the manufacturing license

Documents For Obtaining General Hospital And Orthopaedic Instruments Licenses For Manufacturing

• Organization identity proof
• Sale Deed or Rent Deed of the Premises
• Plant or Site Master File
• Building Layout with Dimension
• ISO 13485 Certificate and Previous Audit Reports
• Device Master File
• Test License, if any 
• Compliance with the environmental requirements
• Certificate of Analysis of 3 Consecutive Batches