Get your Medical Device Import/Manufacturing License approved quickly with India’s most trusted regulatory consultants.
In India, the manufacturing, import, and distribution of medical devices are strictly governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. As the National Regulatory Authority, CDSCO ensures that every medical device entering the Indian market meets rigorous standards of quality, safety, and performance. Compliance is no longer optional; it is a mandatory legal requirement for any business operating in the healthcare sector.
Non-sterile and non-measuring devices like surgical dressings and bandages.
Devices such as hypodermic needles and blood pressure monitors.
Complex devices including ventilators and orthopedic implants.
Life-critical devices such as cardiac stents and pacemakers.
Optimized workflow to ensure zero delays in licensing.
Guaranteed best pricing with premium service quality.
Guidance even after your certificate has been issued.
10+ years of core regulatory experience in India.
Personalized attention for every single application.
No hidden charges, clear timelines, daily updates.
Identifying the correct category (Class A, B, C, or D) for your medical device.
Preparation of DMF, QMS documents, labeling, and technical dossiers.
Uploading application and fee payment on the official portal.
Resolving CDSCO queries and obtaining the final approved license.
