Posted by Understanding the process of getting a CDSCO physical support medical devices license is significant for both manufacturers and importers. This license, mandated by the Central Drugs Standard Control Organization (CDSCO), ensures that physical support medical devices meet the quality and safety standards before they enter the market. The process of achieving this is lengthy and may confuse you if this is your first time. But in this post, we’ll explain in detail how to get the manufacturing and import physical support medical devices license in India.
What are Physical Support Medical Devices?
Physical support medical devices are different types of equipment designed to stabilise or support the body physically for individuals who have difficulty in moving or maintaining posture independently. They provide structural or functional support to specific body parts. Common examples of such devices include orthosis, Shoulder immobilizer, Orthopaedic bed and the like.
The Physical support medical devices fall under the regulatory frameworks of the CDSCO and the respective state licensing authorities in India. The license by the issuing authority ensures that your devices and equipment meet safety and quality standards before clinicians use them for their patients or for conducting research.
Risk Classes of Physical Support Medical Devices by CDSCO
Before you understand the approval process for the CDSCO physical support medical devices license, you must be aware of the risk class of your device. All physical support medical devices fall under Four classes, i.e., Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (High risk). Some examples of Class A medical devices for physical support are an orthopaedic bed, a walking frame, and a shoulder immobiliser.
Likewise, Class B medical devices with low-moderate risk are equipment like a physical therapy massager and a traction table. An example of a Class C medical device is a neuro-controlled ambulation exoskeleton and Class D is Cervical spine immobilization head ring.
CDSCO Classification of Physical Support Medical Devices
The table below gives the latest classification of physical support devices:
|
S. No |
Name of the Medical Devices |
Risk Class |
| 1 | Ankle continuous passive motion exerciser | B |
| 2 | Ankle/foot orthosis | A |
| 3 | Balance board | A |
| 4 | Bed traction frame | A |
| 5 | Body arch traction table | A |
| 6 | Canalith repositioning procedure chair, manual | A |
| 7 | Cervical spine collar | A |
| 8 | Cervical spine immobilization head ring | D |
| 9 | Cervicothoracic spine orthosis | A |
| 10 | Cervicothoracolumbosacral spine orthosis | A |
| 11 | Chest-oscillation airway secretion clearing system | B |
| 12 | Collar and cuff arm sling material | A |
| 13 | Cranial orthosis | A |
| 14 | Elbow orthosis | A |
| 15 | Finger orthosis | A |
| 16 | Flotation therapy bed, adult | B |
| 17 | Flotation therapy bed, neonatal | B |
| 18 | Foot orthosis | A |
| 19 | Hand orthosis | A |
| 20 | Hand/finger splint | A |
| 21 | Hand/wrist continuous passive motion exerciser | B |
| 22 | Hip/knee continuous passive motion exerciser | B |
| 23 | Horizontal non-powered traction system | A |
| 24 | Incentive spirometer | A |
| 25 | Intermittent traction system | B |
| 26 | Kinetic bed | A |
| 27 | Knee immobilizer | A |
| 28 | Neuro-controlled ambulation exoskeleton | C |
| 29 | Orthopaedic bed | A |
| 30 | Paediatric dorsiflexion slant board | A |
| 31 | Parapodium walking frame | A |
| 32 | Physical therapy massager | B |
| 33 | Shoulder continuous passive motion exerciser | B |
| 34 | Shoulder immobilizer | A |
| 35 | Swivel-walker | A |
| 36 | Toe separator | A |
| 37 | Traction table, line- powered | B |
| 38 | Wrist immobilizer | A |
Types of CDSCO Licenses for Physical Support Devices
Different licenses are required for manufacturing, importing, Test, and for clinical investigation. Your application for a license should match the specific license you need.
- Manufacturing License: The Form MD-5 license is required for manufacturing of Class A & B devices. Form MD-9 is needed to manufacture of Class C & D physical support devices.
- Import License: The Form MD-15 license is required for importing medical devices of all classes.
- Loan License: The loan license is needed to manufacture devices using another manufacturer’s facility. The Form MD-6 is loan license for manufacturing of Class A & B devices. Form MD-10 is loan license for manufacturing of Class C & D physical support devices.
- Test License: The Form MD-13 test license is crucial for manufacturing a limited quantity of devices for testing, Clinical investigation, Demonstration, Training, Test & evaluation. Similarly, Form MD-17 test license is required for importing such devices.
Application Process for CDSCO License for Physical Support Medical Devices
To obtain a CDSCO registration for Physical support medical devices for manufacturing and import licenses, follow these detailed steps aligned with the latest rules in India.
1. Classification of the Device
First, classify your physical support medical device according to CDSCO’s risk-based classes (A, B, C, or D), which have already been mentioned in the previous sections. It will determine the risk profile according to the intended use of your device.
2. Application for Manufacturing License (For Indian Manufacturers)
For Class A & B devices, Indian manufacturers should apply to the State Licensing Authority (SLA). This needs you to fill out Form MD-3 and the license will be issued as MD-5.
For Class C & D devices, apply to the Central Licensing Authority (CLA) using Form MD-7. Your license will be issued as MD-9. Also, your manufacturing facility need to be compliant with ISO 13485:2016 standards for quality management systems, as CDSCO abides by QMS.
3. Application for Import License (For Foreign Manufacturers)
To get an import license for physical support medical devices, foreign manufacturers should appoint an Indian Authorised Agent (IAA). Such an entity or person must have a valid wholesale/manufacturing license.
4. Submit the Application Through the Medical Device Sugam Portal
Medical Device SUGAM is an e-governance platform developed by CDSCO. It is used for CDSCO registration for physical support medical devices, tracking submission status, and communication with CDSCO. Activate your account on this portal to submit the needed documents.
5. Documentation Preparation
Prepare and submit complete technical documentation:
- Device Master File
- Plant Master File
- ISO 13485 certificate
- CE certificate
- Declaration of Conformity
- Free Sale Certificate/ Certificate to foreign government (CFG issued by US FDA)
- Legalised Power of Attorney
- An undertaking that you have provided the correct information
Fee for Manufacturing and Importing Physical Support Medical Devices in India
The regulatory fees in India for the manufacture and Import of physical support medical devices are set according to the device class under the Medical Devices Rules, 2017:
|
Device Class |
Government Fees | Licensing Authority |
Required Licenses |
| Manufacturing License | |||
| Class A | Rs. 5,000 for one site and Rs. 500 for each medical device. | State Licensing Authority (SLA) | Form MD 5/ Form MD 6 |
| Class B | Rs. 5,000 for one site and Rs. 500 for each medical device. | State Licensing Authority (SLA) | |
| Class C | Rs. 50,000 for one site and Rs. 1,000 for each medical device. | CDSCO (Central Licensing Authority) | Form MD 9/ Form MD 10 |
| Class D | Rs. 50,000 for one site and Rs. 1,000 for each medical device. | CDSCO (Central Licensing Authority) | |
| Import License | |||
| Class A | USD 1,000 for one Foreign manufacturing site and USD 50 for each medical device. | CDSCO (Central Licensing Authority) | Form MD 15 |
| Class B | USD 2,000 for one Foreign manufacturing site and USD 1,000 for each medical device. | CDSCO (Central Licensing Authority) | |
| Class C | USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device. | CDSCO (Central Licensing Authority) | |
| Class D | USD 3,000 for one Foreign manufacturing site and USD 1,500 for each medical device. | CDSCO (Central Licensing Authority) |
*Note that this license is valid for 5 years and is renewable with a retention fee before expiry.
How to Report Post-Approval Changes in Physical Support Medical Device?
According to CDSCO, Post Approval Changes must be reported to the licensing authority which includes but not limited to following:
- Construction material
- Design that impacts the quality of the device
- Performance and stability of the equipment
- Purpose or use
- Sterilization method
- Official shelf life
- The name or address of the Indian manufacturer or its manufacturing site
- The name or address of the Overseas manufacturer or its manufacturing site (for importers)
- Change in the Indian authorized agent.
- Change in label
- Manufacturing process or testing that impact’s the performance or quality of the device
- Packaging material
To report the changes, you must prepare the updated documents. It should have the updated specifications, risk assessments, test results, packaging designs, and SOP’s. After that, submit the application to CDSCO under the Post Approval Changes category.
How Dueran Consultant Helps You?
Our team offers specialised regulatory consulting to help manufacturers and importers secure CDSCO physical support medical device licenses with ease. The licensing process may look easy, but it is complex and needs due diligence. We help make it easier for our clients through end-to-end support and guidance with form submissions, documentation, and interactions with the issuing authorities for both manufacturing and import permits.
Our Dueran consultant experts handle applications for Low to moderate & moderate to high-risk devices. We provide complete support for notified and non-notified medical devices. Contact us anytime to book a free consultation for your case.
