We act as your compliance engineers to navigate the Central Drugs Standard Control Organisation (CDSCO). From mapping intended use risk classes to auditing Device Master Files (DMF) and Plant Master Files (PMF), we secure your MD-15 and manufacturing licenses with maximum transparency.
Request Compliance ConsultationOnboarding your business as a manufacturer or importer on the CDSCO Sugam portal requires absolute structural validation. We set up your corporate profile, assign permissions, and facilitate the appointment of your Authorized Indian Agent (AIR) to establish a lawful clearance pathway.
We review power of attorney documents, clarify corporate profiles, and manage active portal validations to ensure there are no registration delays.
Any medical device imported into India requires an MD-15 License under MDR 2017. We handle the compiling of technical dossiers, verify the status of foreign manufacturer compliance certificates, and translate legal documents.
Our technical team reviews foreign testing files, aligns intended use claims, and responds to CDSCO technical evaluation queries to secure fast-track approvals.
Securing a license to manufacture medical devices in India (Form MD-5 for Class A/B, MD-9 for Class C/D) requires detailed layout audits. We structure floor plans, prepare production equipment validation logs, and establish cleanroom controls.
We prepare your team for physical inspections by regulatory authorities and guarantee first-time-right site clearance audit ratings.
We review your product specifications against CDSCO's latest MDR 2017 Chapter II risk classification (Class A, B, C, D). We perform complete validation checks on Device Master Files (DMF) and Plant Master Files (PMF) before submission.
Our technical audits verify performance testing parameters, biocompatibility metrics, and label standards matching Chapter X rules.
Whether you need CDSCO Sugam portal onboarding, NABL ISO 17025 audits, radiation safety layouts, or MoEFCC import clearance approvals, our regulatory engineering specialists are ready to secure your approvals.
Request a call with our compliance leads. Receive complete document checklist verification in 15 minutes.