Start Medical Devices Business in India
Want to start a Medical Devices Business in India? Pharmadocx Consultants is your expert ally! We specialize in simplifying the complex process of establishing a medical devices business in India. From navigating the regulatory landscape to obtaining essential CDSCO medical devices Manufacturing, Import, and Test licenses, our team is equipped to guide you every step of the way. We offer comprehensive documentation services, including Device Master Files, SOPs, Essential Principle Checklists, and Risk Management, ensuring compliance and ease in your business setup. Moreover, as holders of the CDSCO MD42 license, IEC Code, and ISO 13485 certification, we’re uniquely positioned to serve as authorized agents, helping you launch and grow your medical devices venture with confidence and expertise.
Services provided by us for Medical Devices Business
Authorised Agent Services
At Pharmadocx Consultants, we offer a vital Authorized Agent service, catering to foreign companies aiming to enter the Indian medical devices market. Understanding that establishing a local presence can be challenging, we step in as your authorized agent in India, experts at navigating the complexities of registration and market entry. As your representative, we shoulder the responsibility for all import and business activities, ensuring compliance with the stringent provisions of the regulations. Our expertise extends to holding a valid IEC Code, SIO 13485 & CDSCO MD42 license for the sale and distribution of medical products and services, coupled with the proficiency to file applications with the Central Licensing Authority for Medical Device registration. Entrust us at Pharmadocx Consultants to be your reliable partner in India, paving the way for your medical device business to flourish in this dynamic market.
License Services
We offer fast and specialized regulatory guidance and assistance in obtaining CDSCO licenses for medical devices, ensuring seamless compliance with India’s healthcare standards.
MD5 License for Class A & B Medical Devices
Medical Devices License by CDSCO for Manufacture and Sale of Class A and Class B Devices.
MD9 License for Class C & D Medical Devices
Medical Devices License by CDSCO for Manufacture and Sale of Class C and Class D Devices.
MD15 Import License for Medical Devices
Regulatory Services for Import License by CDSCO on Form MD15 for Medical Devices in India.
MD13 Medical Devices Test License
Manufacturing License for Medical Devices by CDSCO for the purpose of Testing, Evaluation, and Training.
Documentation
Device Master Files
Device Master Files are crucial documents that detail your product’s specifications and manufacturing processes, ensuring regulatory compliance and quality assurance in the medical devices industry.
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ISO 13485
ISO 13485 certification represents a commitment to quality management systems specifically designed for the medical device industry, ensuring best practices in design, development, and production.
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Essential Principle Checklist
The Essential Principle Checklist is a comprehensive tool that verifies your medical device’s adherence to the critical safety and performance standards required by regulatory authorities.
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Quality Management System (QMS)
QMS Documentation is the backbone of your quality management system, detailing procedures and practices to consistently meet customer requirements and regulatory standards in the medical device sector.
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Plant Master Files
Plant Master Files meticulously document your manufacturing facility’s layout, processes, and controls, showcasing your commitment to excellence in medical device production.
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Risk Management
Risk Management documentation is pivotal in identifying, assessing, and mitigating potential risks, ensuring the highest safety and performance standards for your medical devices.
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Our Clients
Why choose Pharmadocx Consultants?
Medical Device Licences
Years Experience
Plants Set-up
Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
Phone / Whatsapp
Address
- Sonipat Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Delhi Office - G-12, Pearls Best Heights-I, Netaji Subhash Place, Delhi, 110034