Hospital beds are specialized beds that are designed for use in healthcare facilities, like hospitals, clinics, and long-term care centres. Medical-surgical bed, hydraulic bed, manual bed, electric bed, bariatric bed, birthing bed, orthopedic traction bed, etc. are some examples. Moreover, use of hospital beds is not limited to hospitals. They are also used in various healthcare settings, including nursing homes, outpatient clinics, assisted living facilities, and home healthcare setups. Given the versatile role of hospital beds in the healthcare sector, they have to be properly regulated. CDSCO, the apex medical device regulatory body, oversees hospital beds in India. Compliance with CDSCO medical device regulatory guidelines is a mandatory requirement. Hence, manufacturers will have to secure the CDSCO license for manufacturing hospital beds.
Hospital beds provide a safe and comfortable resting place for patients who are ill, injured, or recovering from medical procedures. They have been designed to enhance patient comfort, safety, and facilitate caregiving. Additionally, they are equipped with features, such as height adjustability, head and foot sections, and side rails.
Demand for hospital beds in India
India has a large and growing population. Hence, the overall demand for healthcare services, including hospital beds, is always on the rise. The demand for hospital beds is higher than the supply. India is facing a shortage of hospital beds. Hence, entering the hospital bed manufacturing business will more profitable now than ever. We have listed some factors driving the demand for hospital beds in India.
Key factors driving demand:
- Aging population: With rise in aging population, the need for specialized care and long-term hospitalization is increasing. This is driving the demand for hospital beds.
- Specialized care: India is witnessing a rise in demand for specialised and advanced care that requires specialized beds, such as ICU beds, orthopaedic beds, and bariatric beds.
- Increasing chronic diseases: Prevalence of chronic disease is increasing in India. Conditions, such as diabetes, heart disease, and cancer, often require long-term hospitalization and specialized care. Hence, the need for beds to cater to these patients is increasing.
- Private hospital expansion: Private hospital chains and super speciality hospitals are increasing in number across the country, which is naturally driving the demand for hospital beds.
- Critical care: The COVID-19 pandemic highlighted the need for increased bed capacity, especially in critical care units. Post pandemic the number of hospital beds has been increased to handle future pandemic like situations.
- Medical tourism: India is a popular medical tourism destination, as it offers high-quality medical procedures at competitive prices. This is increasing the strain on existing resources and driving the demand for beds to fulfil its needs.
We have highlighted the rise in demand for hospital beds in India. Entrepreneurs planning to venture into the medical device industry can focus on this sector. Manufacturing hospital beds to cater to the high demand in India can be profitable. However, hospital beds in India are regulated under MDR, 2017. Hence, securing the CDSCO license for manufacturing hospital beds is a mandatory requirement.
CDSCO license for manufacturing hospital beds
CDSCO has classified medical devices into various classes for ease of licensing and registration. The CDSCO medical device classification system is based on the level of risk associated with the medical device. The CDSCO class will determine the license type and the application pathway. Hospital beds are designated as CDSCO class A devices. Hence, the CDSCO manufacturing license and application pathway will be determined accordingly.
- License for manufacturing hospital beds: The CDSCO license for manufacturing hospital beds is MD 5. The applicant will have to use MD 3 to apply for a license to manufacture, sell, and distribute hospital beds in India. The license to manufacture hospital beds for sale and distribution in India will be granted under MD 5.
- Loan license: A loan license permits a company without a manufacturing facility to manufacture hospital beds. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the same product. The applicant will have to use MD 4 to apply for a loan license for hospital beds. The loan license to manufacture hospital beds without a manufacturing facility will be granted under MD 6.
Documents required for securing CDSCO hospital bed 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
- 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.
- ISO 13485 certificate validating the manufacturing facility meets international criteria for quality management systems.
How to obtain CDSCO license for manufacturing hospital beds?
- Login/Signup on the portal: Register on the official CDSCO online portal, SUGAM.
- Document preparation: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- License application: Fill in the application form (MD 3 or MD 4) with all the required details. Ensure accuracy and completeness.
- Online submission: Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees.
- 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.
- 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.
- 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 manufacturing hospital beds will be granted. This license will permit you to manufacture hospital beds for sale and distribution in India.
Validity of the CDSCO hospital bed manufacturing license
The CDSCO hospital bed manufacturing license remains valid indefinitely. However, a license retention fee has to be paid every 5 years.
Why should you secure a CDSCO license?
- Regulatory compliance: Having a CDSCO license for manufacturing hospital beds demonstrates regulatory compliance.
- Builds patient trust: CDSCO manufacturing license helps to gain credibility and build trust among patients. It demonstrates commitment to patient safety.
- Promotes patient safety: A CDSCO manufacturing license indicates the hospital beds are safe to use and are of high-quality standard.
- Protection from regulatory sanctions: Securing the CDSCO license is a mandatory requirement. Non-compliance with CDSCO guidelines and not having a CDSCO license can lead to regulatory sanctions as well as fines and penalties. Additionally, this will damage the company reputation.
Navigating the CDSCO regulatory guidelines to secure the CDSCO medical device license can be a tricky task. We will leverage our expertise and industry knowledge to help you easily secure the CDSCO hospital beds license. We offer the following services:
- Document preparation
- Application filing
- Implementation of QMS
- Mock audit service
- Acting as a liaison between you and CDSCO officials
- CDSCO query response
- Post license support
Email at [email protected] or call/Whatsapp on 9996859227 to easily secure the CDSCO license for hospital beds in India.
