Yes, as per the notification S.O. 648 (E) dated 11.02.2020, all Medical Devices are regulated under the Medical Devices Rules, 2017.

How Satori OCS Can Help Clients with Compliance Under Medical Devices Rules, 2017

With the implementation of the Medical Devices Rules, 2017, and the notification S.O. 648(E) dated 11.02.2020, all medical devices in India are now regulated, requiring strict adherence to quality, safety, and compliance standards. Satori OCS provides comprehensive regulatory and quality management solutions to help medical device manufacturers, importers, and distributors comply with these regulations efficiently.

1. Regulatory Compliance Guidance
   • Assistance in classifying medical devices as per risk categories (Class A, B, C, and D).
   • Guidance on obtaining CDSCO registration and license for medical devices.
   • Support in documentation and dossier preparation for regulatory submissions.
2. Quality Management System (QMS) Implementation
   • Establishment of ISO 13485:2016-compliant QMS to meet regulatory requirements.
   • Development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) tailored to the Medical Devices Rules, 2017.
   • Internal audits and gap analysis to ensure compliance readiness.
3. Product Registration and Licensing Support
   • Assistance in preparing and submitting Form MD-5, MD-7, MD-9, or MD-15 as applicable.
   • End-to-end support for obtaining Import, Manufacturing, or Sale licenses under MDR, 2017.
   • Liaison with CDSCO and State Licensing Authorities for approvals and renewals.
4. Post-Market Surveillance & Risk Management
   • Implementation of a robust Post-Market Surveillance (PMS) system as required under MDR, 2017.
   • Support in handling adverse event reporting and recall management.
   • Compliance with Unique Device Identification (UDI) and vigilance reporting requirements.
5. Software as a Medical Device (SaMD) Compliance
   • Guidance on regulatory classification and documentation for SaMD products.
   • Assistance with software validation, cybersecurity requirements, and risk management in alignment with ISO 14971.
   • Preparation for audits and compliance checks specific to digital health solutions.
6. Training & Continuous Support
   • Training programs on MDR, 2017, regulatory updates, and QMS best practices.
   • Ongoing advisory services to ensure compliance with evolving regulations.
   • Custom solutions to address specific regulatory challenges faced by clients.

Why Choose Satori OCS?

• Expertise in Medical Device Regulations – Our team stays up to date with MDR, 2017, and global standards like ISO 13485, IEC 62304, and ISO 14971.
• End-to-End Compliance Support – From registration to post-market compliance, we cover the full lifecycle of medical devices.
• Tailored Solutions for SaMD & Medical Devices – Specialized services for digital health and traditional medical device companies.

With Satori OCS, you can navigate the complex regulatory landscape with confidence, ensuring your medical devices meet all legal and quality requirements under MDR, 2017.

Contact Satori OCS Today

Ready to take the next step in navigating FDA regulatory controls for your medical device? Reach out to Satori OCS for expert guidance and support.

Contact Information:

• Email: satoriocs@gmail.com
• Phone: +91 98290 98077
• Website: www.satorics.com

Let us help you streamline your regulatory submission process and bring your medical device to market with confidence.