Regulatory & Public Policy Services
CDSCO, FDA, MDR/IVDR Regulatory Consulting with Public Policy Support
Your End-to-End Partner for Medical Device & Diagnostic Regulatory Approvals
Bringing a medical device or diagnostic to market requires a deep understanding of regulatory frameworks, documentation, and compliance protocols. At D2R Global Consulting, we simplify this journey by offering customized regulatory support for Indian and international approvals. Our services cater to both startups and established enterprises, providing guidance from documentation to approvals, audits, and post-market responsibilities.
In addition to regulatory consulting, our Public Policy Services help clients engage with the broader policy ecosystem—supporting advocacy efforts, stakeholder consultations, access to government schemes, and alignment with emerging regulations. From shaping narratives to navigating government incentives and global public affairs, we ensure your innovation is not only compliant but also strategically positioned within the policy landscape.
India Regulatory Approvals (CDSCO & Related Authorities)
Test License (CDSCO/DCGI)
A test license is a prerequisite for conducting performance evaluations or clinical investigations in India. D2R helps prepare the required protocols, ethical clearances, and applications under Form MD-16 (medical devices) and MD-17 (IVDs). We ensure the documentation aligns with the Medical Device Rules, 2017, and manage the full submission cycle via the SUGAM portal, enabling timely initiation of studies.
Wholesale License (Form MD-42)
Distributors and marketers of Class A and B medical devices in India require a wholesale license under Form MD-42. Our team assists in compiling the essential documents including personnel qualifications, site infrastructure details, and standard operating procedures. We liaise with state licensing authorities to streamline inspections and ensure approval readiness.
Manufacturing License (Form MD-5/MD-9)
We help Indian manufacturers obtain manufacturing licenses for all classes of medical devices. This includes support in plant layout (compliant with ISO standards), documentation of processes, establishing a QMS (ISO 13485), and preparing for CDSCO audits. We also guide validation protocols and product master files to ensure full compliance.
Loan License (Form MD-6/MD-10)
For innovators without manufacturing facilities, D2R assists in obtaining a loan license by identifying certified manufacturing partners. We prepare all necessary agreements, documentation, and device-specific information to ensure compliance with CDSCO requirements and successful issuance of the loan license.
Import License (Form MD-14/MD-15)
Overseas manufacturers or Indian importers need a CDSCO import license to legally market medical devices in India. We manage the classification, prepare the Device Master File (DMF), Product Information File (PIF), and ensure label compliance. Our team oversees the submission via the SUGAM portal and manages all clarifications raised during review.
Authorized Representative (AR) Services
Foreign manufacturers must appoint an Indian Authorized Representative (AR) to act as their local liaison. D2R offers AR services, handling all communications with CDSCO, maintaining vigilance records, facilitating regulatory submissions, and ensuring continued compliance post-approval.
International Certifications & Approvals
CE Certification (EU MDR/IVDR)
For access to the European market, CE certification is mandatory. We assist in determining device classification, preparing technical documentation, conducting risk assessments, and drafting clinical evaluation reports in line with EU MDR/IVDR standards. Our team coordinates with Notified Bodies for conformity assessment and final approval.
US FDA Submissions (510k, PMA, IDE, Q-Sub)
We offer regulatory strategy and full submission support for FDA pathways including 510(k), PMA, IDE, and Q-Sub. From identifying predicate devices to compiling performance data, preparing eSTAR files, and facilitating pre-submission meetings, we ensure a smooth route to FDA clearance or approval.
CLIA Certification
For labs operating or offering services in the US, CLIA certification ensures compliance with federal laboratory testing standards. We help diagnostic labs prepare SOPs, validation data, and documentation required for successful registration and audit clearance.
Health Canada Licensing
We support manufacturers entering the Canadian market by facilitating Medical Device License (MDL) and Medical Device Establishment License (MDEL) applications. This includes classification, bilingual documentation, risk assessment, and ISO 13485 integration.
UKCA Certification
Post-Brexit, we assist clients in adapting their CE-compliant documentation to UKCA standards. This includes updating labeling, safety data, and coordinating with UK-approved bodies for certification.
COFEPRIS (Mexico) Registration
We provide regulatory submission support for the Mexican market, ensuring all documentation meets COFEPRIS requirements including Spanish-language compliance, labeling, and performance evaluations.
Singapore & Malaysia Registrations
Our team prepares and submits technical dossiers to HSA (Singapore) and MDA (Malaysia), ensuring compliance with ASEAN Medical Device Directive (AMDD) guidelines and local authority expectations.
Indonesia & Sri Lanka Registration
We help clients enter South Asian markets by preparing country-specific regulatory documentation, product testing protocols, and navigating approval timelines with NMRA (Sri Lanka) and BPOM (Indonesia).
India-Based Statutory & Operational Approvals
KPME Registration (Karnataka Private Medical Establishment)
KPME registration is mandatory for clinics, diagnostic centers, and healthcare establishments operating in Karnataka. D2R supports clients by preparing HR records, infrastructure documentation, and SOPs required for registration, while coordinating inspections and ensuring compliance with KPME norms.
EPR Registration from CPCB (MoEFCC)
Extended Producer Responsibility (EPR) mandates that manufacturers and importers of electronic or plastic products are accountable for their end-of-life disposal. We facilitate CPCB registration under the Ministry of Environment, Forest and Climate Change (MoEFCC), prepare compliance reports, and assist with sustainable waste management practices.
PC-PNDT Registration
For facilities using ultrasound machines, registration under the Pre-Conception and Pre-Natal Diagnostic Techniques Act is compulsory. D2R helps prepare required affidavits, signage, equipment declarations, and manages coordination with district authorities for approval and inspections.
AERB License via eLORA
For radiological devices like X-ray, CT, and PET scanners, we assist with eLORA-based licensing issued by the Atomic Energy Regulatory Board (AERB). This includes QA documentation, site and layout approvals, radiation safety compliance, and coordination for inspection and approval.
Legal Metrology License
For devices involving weight, volume, or measurement (e.g., BP monitors, weighing scales), Legal Metrology approval is required. We guide clients through application, packaging label compliance, verification, and stamping procedures under the Department of Consumer Affairs.
NPPA/DPCO Compliance Support
Medical devices classified as “notified” under NPPA price control require strict adherence to pricing regulations. We help companies resolve overpricing issues, file justifications for price revisions, and manage DPCO compliance communications to avoid penalties.
Biodiversity Act Compliance
If a company uses biological resources (plant extracts, enzymes, cell cultures), it must register under India’s Biodiversity Act. D2R assists in navigating access and benefit-sharing (ABS) agreements, facilitating online registration, and documentation as per State Biodiversity Boards and NBA guidelines.
GeM Portal Registration
We assist companies in registering with India’s Government e-Marketplace (GeM) for participation in public procurement. This includes compliance with TReDS, product listing with specifications, eligibility documentation, and readiness for tenders.
IVD Performance Evaluation – NIB
For IVD manufacturers, evaluation at the National Institute of Biologicals (NIB) is often a prerequisite. D2R helps prepare and submit samples and documents for testing, manage interactions with the institute, and compile performance data to support regulatory submissions.
Wireless, Telecom, and IT Approvals
WPC Equipment Type Approval (ETA)
Devices equipped with wireless communication (e.g., Bluetooth, Wi-Fi) require Type Approval from India’s Wireless Planning & Coordination Wing. D2R facilitates RF testing and submission of technical documents to obtain ETA certification quickly.
TEC Approval – MTCTE Scheme
We support TEC registration for devices connecting to public telecom networks. This includes preparation of technical compliance documents, liaison with BIS-accredited labs for safety testing, and final submission under the Mandatory Testing & Certification of Telecom Equipment (MTCTE) scheme.
Strategic Regulatory Services & Global Trade Enablers
Refurbished Medical Device Compliance
We help clients establish processes to import, recondition, and market refurbished medical devices within Indian regulatory frameworks. This includes documentation, labeling requirements, traceability protocols, and statutory guidance for approvals.
STPI/Non-STPI Registration (Software Technology Parks of India)
SaMD or cloud-based healthcare service providers exporting software abroad must register under the STPI scheme. D2R manages STPI or Non-STPI registration, facilitates Softex form processing, and ensures alignment with RBI and IT/ITES export compliance norms.
Export Oriented Unit (EOU) Registration
We support MSMEs and large enterprises in securing 100% EOU status, which allows for customs duty exemptions on imported goods and benefits on exports. Our services include eligibility assessment, documentation, and liaison with the Development Commissioner’s office for final approval.
Public Policy Services
Strategic policy intelligence, advocacy, and institutional engagement for innovators navigating the Indian and global regulatory landscape.
Our Public Policy services are designed to complement regulatory strategy with policy foresight, institutional outreach, and government program enablement. We support clients in shaping policy dialogue, accessing government incentives, and aligning with national and international compliance frameworks
Policy Research & Analysis
We conduct in-depth policy assessments and regulatory scans to inform your advocacy and compliance strategy.
Scope of Work:
- Regulatory and legislative impact assessments
- White paper development and policy gap analysis
- Strategic insights for emerging compliance trends
Outcome: Actionable insights and evidence-based inputs for internal decision-making and external stakeholder engagement.
Government & Stakeholder Engagement
- Stakeholder mapping and engagement planning
- Setting up meetings, roundtables, and technical consultations
- Drafting talking points and engagement documentation
Regulatory Advisory
Cross-sectoral expertise to help clients anticipate, interpret, and adapt to policy changes across healthcare, sustainability, and digital domains.
Scope of Work:
- Draft policy reviews and response submissions
- Regulatory interpretation across emerging sectors
- Strategy formulation for policy shifts (e.g., DPDPA, MDR/IVDR, CPCB)
Outcome: Proactive compliance and strategic alignment with evolving legal frameworks.
Policy Advocacy & Positioning
We help shape the narrative through strategic communications, evidence-based campaigns, and issue framing.
Scope of Work:
- Development of advocacy strategies
- Stakeholder briefing kits, policy narratives, and socialization materials
- Public consultation engagement and response formulation
Outcome: Increased influence on policy decisions and enhanced positioning of innovation within the regulatory ecosystem.
Scheme & Incentive Advisory
We help identify, access, and optimize participation in government schemes, grants, and subsidies.
Scope of Work:
- Mapping of applicable central/state schemes (PLI, BIRAC, MeitY, DBT, etc.)
- Application and documentation assistance
- Structuring of fiscal and non-fiscal incentives
Outcome: Enhanced financial viability and accelerated growth through government-backed incentives.
Global Public Affairs
Strategic guidance on international regulatory convergence, trade policy, and global stakeholder engagement.
Scope of Work:
- Inputs for Free Trade Agreements (FTAs) and bilateral trade dialogues
- Coordination with foreign regulators and multilateral institutions
- International representation of regulatory issues
Outcome: Seamless global expansion and participation in transnational regulatory and policy platforms.