CDSCO Medical Device Consultant 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. Learn More
CDSCO Medical Device 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.
Medical Device Documentation Services
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.
Learn More
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.
Learn More
Essential Principle Checklist
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.
Contact Us
Plant Master Files
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.
Learn More
GLOBAL MEDICAL DEVICE CONSULTANT SERVICE
US FDA 510(k)
Our expertise and support can help you easily clear the US FDA 510(k) regulatory process. We are a team of seasoned professionals well-versed in FDA regulations and submission requirements. We will leverage our expertise to help you achieve the approval and registration in a seamless manner.
CE Marking
With our support, you can easily secure the CE marking certification. We specialize in guiding manufacturers through every step of the CE marking process. Our team will guide you through risk classification, technical documentation, performance evaluation, and obtaining the certification.
Health Canada
We have extensive knowledge in Health Canada regulatory requirements. Our team will help you easily secure the Health Canada MDL/MDEL for your medical device. With our support, you can easily launch your medical in Canada in a hassle-free manner.
SFDA Consultant
As a trusted Saudi Arabia medical device registration consultant, we offer comprehensive regulatory services. We will help identify the correct medical device class, prepare documents, file the application, prepare query response and provide assistance till you successfully secure your registration.Â
Frequently Asked Questions (FAQs)
What license is required to manufacture medical devices in India?
CDSCO MD5 license will be required to manufacture Class A and B medical devices in India. CDSCO MD9 license will be required to manufacture Class C and D medical devices in India.
What license is required to import medical devices into India?
CDSCO MD15 license is required to import medical devices into India.
What is ISO 13485 certification and why is it important?
ISO 13485 is an international standard for Quality Management Systems (QMS) in medical devices. It is often required for licensing, audits, and global market access.
What is a Device Master File (DMF)?
A DMF is a detailed dossier containing information on the design, manufacturing process, quality controls, and compliance of a medical device, required for regulatory submissions.
What is a Plant Master File (PMF)?
A PMF describes the facility, equipment, personnel, and QMS of a medical device manufacturing site, used during audits and licensing.
What is the difference between a manufacturing license and a loan license for medical devices?
- Manufacturing license is required for companies owning their own facility.
- Loan license allows manufacturing of medical devices at another licensed facility.
Do medical devices require labeling compliance in India?
Yes. Devices must comply with Medical Device Rules labeling requirements, including product name, manufacturer details, batch number, expiry date, and import license number (if applicable).
What is the process to start a medical device business in India?
It involves company incorporation, facility setup, QMS implementation, CDSCO medical device classification, CDSCO medical device license application, compliance with ISO 13485, and post market surveillance.
Can Pharmadocx Consultants help with CDSCO medical device licensing and compliance?
Yes. We provide end-to-end support for CDSCO medical device licensing, including device classification, documentation, QMS setup, CDSCO submissions, and audit readiness.
Your content goes here. Edit or remove this text inline or in the module Content settings. You can also style every aspect of this content in the module Design settings and even apply custom CSS to this text in the module Advanced settings.
What license is required to sell medical devices in Canada?
Medical devices must be registered with Health Canada for sale in Canada. Depending on risk class, companies may need a Medical Device Establishment License (MDEL) or a Medical Device License (MDL).
What is the difference between MDL and MDEL in Canada?
- MDL (Medical Device License) is required to manufacture Class II, III, and IV devices.
- MDEL (Medical Device Establishment License) is required by distributors, importers, and manufacturers of Class I devices.
Do medical devices need FDA clearance or approval?
Medical devices must undergo either 510(k) clearance (for most Class II devices) or Premarket Approval (PMA) (for high-risk Class III devices) before being marketed in the United States.
What is CE marking for medical devices in Europe?
CE marking indicates that a medical device complies with the EU Medical Device Regulation (MDR 2017) or In Vitro Diagnostic Regulation (IVDR 2017). It allows free sale across the European Economic Area.
What roles do notified bodies play in CE marking?
Notified Bodies are independent organizations designated by EU member states to assess conformity of Class IIa, IIb, and III devices. They review technical documentation, audit QMS, and issue CE certificates.
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
- Head Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Registered Office - Netaji Subhash Place, Delhi, 110034