Chennai, India – August 21, 2025 – Morulaa HealthTech Pvt. Ltd., a leading CDSCO medical device registration consultant in India, announced that Vitaltec Corporation, a global leader in airway management and respiratory care, has received CDSCO MD-15 approval from the Central Drugs Standard Control Organization (CDSCO), under India’s Ministry of Health and Family Welfare, for its Rota-Trach Tracheostomy Tubes. This CDSCO approval marks a significant step forward for patients and healthcare professionals in India introducing a next-generation solution designed to enhance patient safety, comfort, and clinical outcomes in tracheostomy care.
Expanding the Possibilities in Airway & Critical Care
The newly approved Rota-Trach Tracheostomy System includes:
- Rota-Trach (Fenestrated & Cuffed Options) – Designed for adult tracheostomized patients, enabling natural breathing and speech while providing secure airway protection against secretions. Its single-patient-use design supports safe weaning and enhances long-term patient comfort.
“This approval is a vital milestone in bringing innovative airway technologies to India,”. “Every patient deserves safer procedures, stronger recoveries, and renewed quality of life and Vitaltec is proud to make that possible.”
CDSCO Approval and Regulatory Pathways
Foreign manufacturers from Europe and the USA entering India must obtain medical device registration under MDR 2017. This involves CDSCO Form MD-14/MD-15 submissions for import licensing, ensuring compliance with India’s stringent regulatory standards.
Through this process, Vitaltec backed by Morulaa HealthTech’s regulatory consulting expertise successfully achieved MD-15 approval, paving the way for nationwide distribution of its trusted tracheostomy technology.
Morulaa specializes in:
- CDSCO approval consulting
- Import license medical devices India
- Fast-track medical device registration for US and EU manufacturers entering India
Meeting a Growing Market Need
India’s tracheostomy tubes market is poised for robust expansion:
- India Tracheostomy Tubes Market → USD 8.2M by 2030 (CAGR 5.8%, 2024–30)
- India Tracheostomy Products Market → USD 33.5M by 2032 (CAGR 7.9%, 2025–32)
With increasing demand for critical care solutions, Vitaltec’s Rota-Trach system is set to transform patient care in ICUs and hospitals nationwide.
About Vitaltec Corporation
Vitaltec Corporation specializes in airway management and respiratory care, prioritizing patient safety and comfort in every design. With innovative, clinically engineered products, Vitaltec is redefining standards in critical care and empowering healthcare providers worldwide.
Learn more at www.vitaltec-corp.com.
About Morulaa
Morulaa HealthTech is a regulatory consulting firm in India specializing in CDSCO registration, CDSCO approval process navigation, import licensing (Form MD-14/MD-15), and Indian distributor onboarding. Trusted by manufacturers across Europe, the United States, and Asia, Morulaa enables fast-track medical device registration in India under MDR 2017. Visit www.morulaa.com for expert support from an experienced CDSCO consultant in India. Also follow us on Facebook, LinkedIn, and Twitter
Forward-looking Statements
This document contains forward-looking statements regarding plans, expectations, and future events. Forward-looking statements involve risks and uncertainties that could cause actual outcomes to differ. Statements are based on current information as of this release date and are not guarantees of future performance.