Medical Devices Regulatory Services in India
Artixio is a Leading Medical Device Regulatory Consultant in India, your Partner for End-to-End Regulatory Services in India, From Strategy to Registration and Post Approval Maintenance.
Artixio offers extensive regulatory services to global manufacturers, facilitating smooth navigation of India’s CDSCO regulations.
The Central Drugs Standard Control Organization (CDSCO) regulates the registration of medical devices in India. The registration makes sure that the devices meet safety and performance standards before they can be marketed.
Our Services
Regulatory Intelligence & Strategy
MDR Gap Assessment
Medical Device Regulatory Affairs
Quality Consulting
Technical and Medical Writing
Clinical, Performance Evaluation
Medical Device Registration / Certification
Authorized Agent / Legal Representation
Post Market Surveillance
Key Regulations for Medical Devices in India
Classification of Medical devices In India
Medical Devices is categorized into four risk categories: A, B, C, and D. The CDSCO processing fees for the application are determined by the device Class. The process takes 6 to 9 months regardless of the Class.
Process for Registration of Medical Devices in India:
Documents Required for Registration of Medical Devices in India
- Form 40
- TR6 Challan
- Power of Attorney
- Schedule D(I)
- ISO 13485 Certificate
- Quality Assurance Certificate
- CE Certificate
- Declaration of Conformity
- Free Sale Certificate
- Post Marketing Study Reports
- Plant Master File
- Device Master File
Artixio’s Medical Devices Regulatory Compliance Services in India
Our Regulatory and Market Access experts based in India, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in India. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.
For Medical Devices, from strategic planning and registration to post-market compliance, Artixio provides high-quality regulatory affairs services to support your business needs.
Why Artixio?
FAQS
1. Who act as the Central Licensing Authority for Medical Devices in India?
2. What is the mode of submission of various applications in MDR-2017 to the Licensing Authority?
3. If a device is complying with ISO/IEC standards, would it still need to follow BIS standards?
4. What are the Labeling requirements for Medical Devices in India?
5. Is a license is required for import of medical device for marketing in India?
6. Who is an “Authorized agent” for import of medical devices in the country?
7. What is the timeline for the grant of Import license in Form MD-15?
Regulatory Expertise Across
Multiple Countries
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