Get CDSCO License for Hospital Furniture in Delhi

Hospital furniture is a staple requirement in any healthcare setting. As they impact how patient care is delivered and patient safety, they have to regulated similar to medical devices. Hospital furniture is in high demand in Delhi. Hence, medical device companies are venturing into the hospital furniture business to cater to the demands in Delhi. For ensuring quality and safety, securing the CDSCO license for hospital furniture is mandatory to sell your products in Delhi.

11 Common types of hospital furniture

1. Examination tables: Examination tables are a stable and adjustable surface for patient checkups and even minor procedures. Some of them also have stirrups and storage drawers. These tables are mostly used in clinics and exam rooms.
2. Patient beds: Patient beds are the most common hospital furniture in any healthcare setting. Standard beds, paediatric beds, ICU beds, and specialized beds are all used for specific purposes. They have features, such as adjustable height, backrests, and side rails, to enhance patient comfort and safety.
3. Stretchers: Stretchers are another common hospital furniture. They are critical for safely moving around patients during emergencies or surgical prep. They are usually equipped with features like adjustable height and backrest positions, side rails, IV poles, and wheels with locking mechanisms.
4. Overbed tables: These adjustable tables are positioned over the patient beds for eating or other activities.
5. Wheelchairs: Wheelchairs can be manual or automated. They are used for transporting patients who cannot walk or have difficulty walking.
6. Ward screens/privacy curtains: These curtains or screens are used to provide privacy to patients during examinations and treatments in hospital settings.
7. IV stands/poles: These are used to hold intravenous fluid bags and equipment used for IV drips.
8. Hospital chairs: Hospital chairs include recliners, infusion chairs, and transport chairs. They are used in consultation rooms and treatment zones. With features, such as ergonomic designs, armrests, and soft padding, they are designed to provide patient comfort.
9. Medical carts and trolleys: Medication carts, anesthesia carts, instrument trolleys, and utility carts are commonly used in hospitals. Built for easy mobility and efficient storage, they are used to organize and transport essential medical supplies.
10. Patient lifts/hoists: These are used to safely lift and move patients having limited mobility.
11. Infant cribs/bassinets: Safe sleeping areas for newborns in maternity and paediatric wards.

Regulations for hospital furniture

Hospital furniture is treated like medical devices and are regulated accordingly for patient safety. We have highlighted some of the regulations hospital furniture has to abide by to secure the license for hospital furniture. 

• Safety guidelines: Hospital furniture has to comply with safety standards for the well-being of patients and healthcare providers. There are guidelines for structural stability, weight capacity, durability, fire safety, electrical safety, and ergonomics of the hospital furniture.  
• Infection control: Hospital furniture is prone to be contaminated and spread infection. Hence, they should be designed and manufactured with provisions for infection control. Materials that are easy to clean and disinfect should be used. Areas where bacteria have a tendency to accumulate should be minimised.  
• Accessible and accommodating furniture: Hospital furniture should be designed to accommodate the needs of individuals with varying ability and mobility limitations.
• Labelling and documentation: Proper labeling and documentation are mandatory requirements of medical device regulations. Hence, hospital furniture has to abide by labelling guidelines to facilitate easy identification, maintenance, and traceability.
• Furniture integrated with medical device: Some hospital furniture, such as patient beds or examination tables, are integrated with medical devices or accessories. Such furniture has to comply with applicable medical device regulations for the device.

CDSCO license for hospital furniture in Delhi

Hospital furniture being manufactured or imported for sale and distribution in Delhi have to comply with CDSCO medical device regulations. CDSCO license for hospital furniture has to be mandatorily secured.

Manufacturing license for hospital furniture in Delhi

CDSCO has categorised medical devices into four classes based on the associated risk level. This CDSCO medical device classification system has been developed to simplify the CDSCO medical device license application process. Most hospital furniture is categorised as CDSCO class A or B. Hence, the CDSCO manufacturing license for hospital furniture in Delhi is MD 5. An application has to be filed under Form MD 3. The license to manufacture hospital furniture for sale and distribution in Delhi will be granted under MD 5. The license will be granted by the state licensing authority (SLA).

Documents required for securing CDSCO manufacturing license

• Cover letter
• Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
• Sale Deed/Rent Deed proving legal ownership of the manufacturing facility.
• Facility building layout presenting the dimensions of each room and the location of all the equipment in the manufacturing facility.
• Plant master file
• Device master file
• Audit reports
• ISO 13485 Certificate validating the manufacturing facility meets international criteria for quality management systems.
• Certificate of analysis of 3 consecutive batches to certify the first 3 batches of the manufactured products meet the required quality benchmarks.
• Test license (if applicable)
• Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the devices.
• Document proving compliance with the environmental regulatory requirements.

Import license for hospital furniture in Delhi

CDSCO import license for hospital furniture in Delhi is MD 15. An application has to be filed under Form MD 14. The license to import hospital furniture for sale and distribution in Delhi will be granted under MD 15. The license will be granted by the central licensing authority (CLA).

Documents required for securing CDSCO import license

• Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority.
• Self-attested copy of valid manufacturing license demonstrating the device is manufactured in accordance with the regulatory requirements of the country of origin.
• Plant master file
• Device master file
• Notarized copy of ISO 13485 certificate of the actual manufacturer
• Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory Authority of country of origin
• Full Quality Assurance Certificate/CE type examination certificate/CE product quality assurance certificate
• Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards
• Notarized CE design certificate
• A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
• Power of attorney, in case an authorized agent has to be appointed
• Constitution details of Indian authorized agent for foreign manufacturers

Step-by-step application guide for CDSCO license for hospital furniture in Delhi

1. Login/Signup on the portal: Register on the official CDSCO online portal, SUGAM.
2. Document preparation: Prepare and compile all necessary supporting documents per CDSCO guidelines.
3. CDSCO hospital furniture license application: Fill in the application form (MD 3 or MD 14) with all the required details. Ensure accuracy and completeness.
4. Online submission: Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees.  
5. CDSCO application review: The CDSCO will review the application for compliance with regulatory guidelines and verify the documents. They will check for any areas of non-conformities.
6. CDSCO query response: CDSCO officials may raise queries asking for additional clarification and further documentation. It is important to promptly and appropriately respond to all queries. Response should be provided in a timely manner along with additional documents (if required) to support the response.
7. Facility inspection and audit: The CDSCO may inspect the facility to verify whether it meets all applicable quality and regulatory standards. CDSCO audits are conducted for ensuring regulatory compliance.
8. License approval and grant: CDSCO will evaluate all the information provided and check the response to the queries. If satisfied, they will approve the application. Then, the CDSCO license for hospital furniture will be granted. This license will permit you to manufacture or import (as applicable) the hospital furniture specified in your application for sale and distribution in Delhi.

Need help securing the CDSCO license for hospital furniture? Email at [email protected] or call/Whatsapp on 9996859227.