Rehabilitation medical devices play a pivotal role in enhancing the quality of life of individuals with disabilities. Additionally, they are used to help those recovering from injuries. These devices have a crucial role in improving the patient’s quality of life and outcome. Hence, their quality, efficacy, and safety have to be rigorously monitored. The Central Drugs Standard Control Organization (CDSCO) oversees the regulatory directives in India. Thus, manufacturers and importers of rehabilitation devices must be well-versed with the CDSCO registration and licensing nuances. In this guide, we offer a thorough insight into CDSCO registration for rehabilitation medical devices. Additionally, we have provided an overview of the CDSCO classification system for rehabilitation devices. Furthermore, we have detailed the documents required and the CDSCO rehabilitation medical device license application process. Finally, we have provided some tips that will help you overcome the common challenges of the CDSCO license application process.

Understanding CDSCO Classification System for Rehabilitation Medical Devices

Medical devices are categorized based on the potential risks associated with their use. They are categorised into four classes, A, B, C, and D. This classification system helps ease out the CDSCO medical device license application process.

Rehabilitation devices are instrumental in facilitating recovery and improving mobility. Thus, they have a crucial role in the healthcare industry. Hence, CDSCO registration for rehabilitation medical devices is mandatory. Notably, different license forms are applicable for different CDSCO medical device classes. This helps simplify the CDSCO registration and license application process. Therefore, you should check which CDSCO class your medical device belongs to before proceeding with the CDSCO license application process.

CDSCO rehabilitation medical device classes

Class A

• Acupressure calf band
• Back pulldown exerciser
• Back row exerciser
• Back/leg/chest dynamometer, mechanical
• Balance ball exerciser
• Standard treadmill, mechanical
• Standard treadmill, powered
• Wall bars
• Telemetric diagnostic spirometer
• Bicycle ergometer
• Blue/red/infrared phototherapy lamp
• Body elastic exerciser
• Body flywheel exerciser
• Cold compression therapy cervical spine collar
• Cold/cool therapy gel
• Gait analysis system
• Hand dynamometer/pinchmeter, mechanical
• Parallel bar exerciser

CDSCO class B

• Arthritis TENS system
• Back/leg/chest dynamometer, electronic
• Balance-training tongue electrical stimulation
• Physical therapy massager
• Physical therapy paraffin wax bath
• Physical therapy steam bath
• Therapeutic nuclear magnetic resonance system
• Bed/chair electric massager
• Bladder-emptying vibratory stimulator
• Hand dynamometer/pinchmeter, electronic

Class C

• Musculoskeletal intense therapeutic ultrasound system
• Musculoskeletal/ physical therapy laser
• Pulsed signal therapy system
• Short-wave diathermy treatment system

CDSCO class D

• Advanced prosthetic limbs
• Spinal cord stimulators
• Functional electrical stimulation devices

CDSCO Registration for Rehabilitation Medical Devices in India

Registration for Rehabilitation Medical Devices in India: License Types

• Manufacturing class A and B rehabilitation medical devices: MD 5 License is required to manufacture class A and B rehabilitation medical devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Additionally, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D rehabilitation medical devices: MD 9 License is required to manufacture class C and D rehabilitation medical devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.
• Importing rehabilitation medical devices into India: MD 15 Import License has to be secured from the CDSCO to import rehabilitation medical devices into India.

Documents Required for Securing CDSCO Registration for Rehabilitation Medical Devices

We have provided an overview of the documents required for securing the CDSCO rehabilitation medical device license.

1. Organization identity proof
2. Sale Deed/Rent Deed of the Premises
3. Plant Master File
4. Building Layout with Dimension
5. Device Master File
6. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
7. Certificate of analysis of 3 consecutive batches
8. ISO 13485 Certificate
9. Test License, if required for testing the rehabilitation medical device
10. Environmental regulation compliance documents

CDSCO Registration for Rehabilitation Medical Devices: Simplified Overview of the Application Process

A step-by-step guide of the CDSCO rehabilitation medical device license application process.

• Document preparation: Collate all pertinent documents, including clinical trial data and product blueprints.
• Application Submission: Submit the application online on the official CDSCO online portal.
• Query Resolution: Promptly address any queries raised by the CDSCO. Additionally, provide any documents required to support the query response.
• Inspection: Be prepared for the CDSCO medical device facility inspection and audit phase.
• License Approval: CDSCO will review the application and verify the documents. Upon meeting all prerequisites, CDSCO will confer the license.

Validity of the CDSCO Rehabilitation Medical Device License

CDSCO rehabilitation medical device license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.

The New CDSCO Guidelines: What’s Changed?

CDSCO, in its mission to ensure patient safety and uphold product standards, has revamped its guidelines. Specifically for Class C and Class D rehabilitation medical devices, the emphasis is on comprehensive testing and best quality assurance practices. Furthermore, the rehabilitation device manufacturing process has to synchronize with global benchmarks. These measures are being implemented to bring India’s medical device sector at par with the global medical device sector.

The Deadline: Key Dates to Remember for CDSCO Rehabilitation Medical Device License Application

CDSCO has transitioned Class C and Class D rehabilitation medical devices from the mandatory registration protocol to a licensing framework. This has been detailed in GSR 102(E) dated 11.02.2020. Notably, this pivotal transition will be operational from October 1, 2023. Rehabilitation device manufacturers and importers should take note of this transition.

Furthermore, manufacturers and importers are urged to familiarise themselves with the Medical Devices Rules (MDR) 2017. They have to file their applications on CDSCO’s online portal, accompanied by the necessary documents and fees. For a granular understanding, the official CDSCO circular serves as a comprehensive resource.

Common CDSO License Application Challenges and How to Overcome Them

Manufacturers and importers might face the following challenges while applying for the CDSCO license. Hence, we have provided some tips to overcome the challenges.

• Documentation Gaps: Ensuring all documents are up-to-date and resonate with CDSCO’s benchmarks. Furthermore, they should be arranged per CDSCO guidelines.
• Delays in Query Resolution: Instituting a dedicated team to swiftly address CDSCO queries.
• Inspection Hurdles: Regularly conducting internal audits of the medical device facilities to ensure alignment with CDSCO standards.

How Can Pharmadocx Consultants Assist in Securing the CDSCO Registration for Rehabilitation Medical Devices?

Compliance with CDSCO guidelines is mandatory to manufacture or import rehabilitation medical devices into India. Notably, regulatory compliance underscores a manufacturer’s commitment to patient well-being and product excellence. Additionally, ensuring compliance not only builds trust but also fortifies the brand’s standing in the industry. Pharmadocx Consultants offers a spectrum of services tailored for rehabilitation medical device manufacturers:

• Expert Guidance: Support throughout the registration trajectory.
• Mock Audits: Orchestrating pre-inspection audits to ensure preparedness.
• Query Resolution: Efficiently addressing CDSCO queries.
• End-to-End Support: Holistic support from the application’s inception to license approval.
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The CDSCO registration for rehabilitation medical devices ensures that healthcare professionals have access to cutting-edge tools for patient care. With adept partners like Pharmadocx Consultants, the CDSCO medical device license application journey will become streamlined and efficient. In need of expert guidance for the CDSCO medical device license application process for rehabilitation medical devices? Drop an email at [email protected] or call/Whatsapp on 9996859227 today!