VSD Regulatory Affairs Consultant Invites Worldwide Clients to Streamline Medical Device Import Licenses in India
How to get Medical device import license – In a rapidly evolving global healthcare landscape, where medical devices play a pivotal role in advancing patient care, navigating regulatory hurdles can often be a daunting challenge for international manufacturers and importers. Enter Satish Mehra, a seasoned expert in medical device import licensing, who is extending an open invitation to worldwide clients through his consultancy firm, VSD Regulatory Affairs Consultant.
Based in India, Mehra’s services are designed to simplify the complex process of obtaining import licenses under the Central Drugs Standard Control Organization (CDSCO), ensuring seamless compliance and market entry for medical devices from around the globe. This announcement comes at a time when India’s medical device market is projected to reach $50 billion by 2025, driven by increasing demand for innovative healthcare solutions.
The Rise of Satish Mehra: From Expertise to Global Outreach
Satish Mehra, with over three years of dedicated experience as a self-employed import medical device consultant, has established himself as a trusted name in the regulatory affairs domain. Starting his journey in January 2022, Mehra has focused on providing end-to-end support for CDSCO licensing, helping clients avoid common pitfalls in India’s stringent regulatory framework. His firm, VSD Regulatory Affairs Consultant, specializes in import license applications, dossier preparation, and compliance guidance, catering to a diverse clientele including manufacturers, importers, and healthcare companies worldwide.
Mehra’s approach is rooted in a deep understanding of CDSCO regulations, which govern the import, sale, and distribution of medical devices in India. Under the Medical Devices Rules, 2017, importers must secure licenses such as Form MD-14 (application for import license) and Form MD-15 (grant of import license), a process that involves rigorous documentation, technical file compilation, labeling requirements, and Instructions for Use (IFU). Mehra’s consultancy demystifies this process, offering step-by-step guidance that has already assisted numerous clients in achieving swift approvals.
In a recent LinkedIn post, Mehra outlined the step-by-step process for approving import medical device licenses, emphasizing the importance of regulatory compliance in avoiding delays or rejections. “Our goal is to make India accessible for global innovators,” Mehra stated in an exclusive interview. “With VSD Regulatory Affairs, clients can focus on their core business while we handle the regulatory intricacies.”
Comprehensive Services Tailored for International Clients
VSD Regulatory Affairs Consultant offers a suite of services aimed at facilitating hassle-free medical device imports into India. Key offerings include:
- Import License Application Support: Assistance with Form MD-14 and MD-15 submissions, ensuring all required documents are accurately prepared and submitted to CDSCO.
- Dossier Preparation: Expert help in compiling technical files, including device specifications, risk assessments, and clinical data, formatted to meet CDSCO standards.
- CDSCO Compliance Guidance: Up-to-date advice on regulatory changes, labeling, and IFU requirements to maintain full compliance and avoid penalties.
- Specialized Support for IVD and Diagnostic Devices: Tailored services for In Vitro Diagnostic (IVD) devices, addressing unique regulatory needs in this growing segment.
- End-to-End Consulting: From initial consultations to post-approval monitoring, VSD ensures a smooth journey for clients entering the Indian market.
What sets VSD apart is its client-centric model, which prioritizes efficiency and transparency. Mehra’s team works closely with regulatory affairs professionals, providing personalized strategies that align with international standards such as those from the International Medical Device Regulators Forum (IMDRF). This is particularly beneficial for clients from Europe, the US, and Asia, where harmonizing regulations with India’s framework can be challenging.
A Facebook post from July 13, 2025, highlights why clients choose VSD: “We offer end-to-end support to manufacturers, importers, and healthcare companies for smooth and compliant medical device import into India.” The post also invites inquiries via WhatsApp at +91-8920964801, underscoring Mehra’s commitment to accessible communication.
Why Now? The Booming Indian Medical Device Market
India’s medical device sector is experiencing unprecedented growth, fueled by government initiatives like “Make in India” and the Production Linked Incentive (PLI) scheme. However, for foreign entities, importing devices requires navigating a maze of regulations enforced by CDSCO, which classifies devices into risk-based categories (A, B, C, D) and mandates licenses for higher-risk items.
Global clients often face delays due to incomplete dossiers or unfamiliarity with local requirements, leading to lost opportunities in a market valued at over $11 billion in 2023. Mehra’s invitation comes as a timely solution, especially amid post-pandemic supply chain disruptions and the push for self-reliance in healthcare.
“International companies are eager to tap into India’s vast patient population and cost-effective manufacturing,” says regulatory expert Dr. Rajiv Singh, a consultant in pharmaceutical affairs. “Consultants like Satish Mehra bridge the gap, ensuring compliance without compromising on speed.”
Client Testimonials and Success Stories
While VSD is relatively new, early clients have praised Mehra’s expertise. One anonymous importer from the EU shared on LinkedIn: “Satish’s guidance on MD-15 licensing was invaluable— we got approval in record time.” Another client, a diagnostic device manufacturer from the US, noted the firm’s role in preparing compliant technical files, avoiding costly revisions.
Mehra’s Instagram presence (@satishadsense) further amplifies these stories, with posts showcasing successful case studies and regulatory tips. His holistic approach extends to IVD devices, where accurate classification and testing protocols are critical.
Potential Challenges and How VSD Addresses Them
Regulatory affairs in medical devices aren’t without hurdles. Common issues include evolving guidelines, language barriers, and the need for local authorized representatives. VSD mitigates these through bilingual support, regular updates on CDSCO notifications, and partnerships with local testing labs.
Mehra emphasizes ethical practices: “We ensure all consultations adhere to global best practices, promoting safe and effective devices for Indian consumers.”
An Open Invitation to Worldwide Clients
Satish Mehra and VSD Regulatory Affairs Consultant are now actively inviting manufacturers, importers, and regulatory professionals from across the world to partner for their medical device import needs. Whether you’re a startup launching innovative diagnostics or an established firm expanding into Asia, VSD offers the expertise to navigate CDSCO with confidence.
Interested parties can reach out directly to Satish Mehra at +91-8920964801 via WhatsApp or phone for a free initial consultation. Visit his LinkedIn profile or Facebook page for more details on services and success stories.
As the global medical device industry continues to integrate, consultants like Mehra are pivotal in fostering international collaboration. This invitation not only opens doors to India’s thriving market but also promises a compliant, efficient pathway to success. For those ready to import innovation, VSD Regulatory Affairs is your trusted ally.