What we do
Medical device regulatory services for India and global markets
India Licensing
Licences and registrations required to manufacture, import, test, distribute and sell medical devices and IVDs in India.
CDSCO Manufacturing Licence
End-to-end support for MD-3 and MD-7 applications, from device classification and master files to audit readiness and grant of licence.
Learn more →CDSCO Import Licence
MD-14 applications and MD-15 import licences for overseas medical device and IVD manufacturers, prepared and managed by one regulatory team.
Learn more →Indian Authorised Agent
Guidance for overseas manufacturers on appointing and working with an Indian authorised agent for CDSCO licensing and post-market duties.
Learn more →CDSCO Test Licence
Test licences in Form MD-13 and MD-17 to make or import medical device samples for testing, evaluation, clinical investigation or training.
Learn more →Wholesale Registration (MD-42)
MD-41 applications and MD-42 registration certificates for traders, distributors and retailers who sell, stock or distribute medical devices.
Learn more →BIS Licence & ISI Mark
BIS product certification and ISI mark licences for medical and hospital products made in India or overseas, from standard mapping to grant.
Learn more →Quality & Compliance
Quality systems, audits, training and ongoing regulatory support that keep your organisation inspection-ready.
ISO 13485:2016 Certification
Build, implement and certify a medical device QMS to ISO 13485:2016 that also meets CDSCO, EU MDR and US FDA QMSR expectations.
Learn more →MDSAP Certification
Prepare for a Medical Device Single Audit Program audit that satisfies the USA, Canada, Australia, Brazil and Japan in one QMS audit.
Learn more →Internal Audit Support
Independent ISO 13485 internal audits, mock regulatory audits and CAPA follow-up by experienced medical device QMS auditors.
Learn more →Supplier Audit Support
On-site and remote audits of critical suppliers and contract manufacturers, with supplier qualification and quality agreement support.
Learn more →Training & Workshops
Practical training on ISO 13485, ISO 14971, CDSCO MDR 2017, EU MDR / IVDR, internal auditing and CAPA, delivered in-house or online.
Learn more →Annual Maintenance Contract
An annual regulatory retainer covering licence upkeep, post-approval changes, PMS and vigilance, audit readiness and regulatory updates.
Learn more →Outsourced Regulatory Staff
Dedicated or shared regulatory affairs and QA professionals on contract, on-site or remote, to run your medical device compliance work.
Learn more →Global Market Access
Registrations for Europe, the United States, the Middle East and South-East Asia, built from one coordinated technical file.
CE Marking (EU MDR / IVDR)
CE marking support under EU MDR 2017/745 and IVDR 2017/746: classification, technical documentation, notified body liaison and EUDAMED.
Learn more →US FDA 510(k)
End-to-end US FDA 510(k) support: predicate strategy, eSTAR preparation, testing plans, registration, listing and US Agent coordination.
Learn more →UAE (MOHAP / EDE)
UAE medical device registration with the Emirates Drug Establishment (formerly MOHAP): classification, dossier and local representative support.
Learn more →Saudi Arabia SFDA
Saudi SFDA medical device registration support: MDMA dossiers on GHAD, Saudi Authorised Representative coordination, MDNR listing and MDEL guidance.
Learn more →Egypt EDA
Egypt EDA medical device and IVD registration support: classification, dossier preparation, CFS legalisation and coordination with your local agent.
Learn more →Sri Lanka NMRA
Sri Lanka NMRA medical device registration support: local agent set-up, product dossiers, site approval, reliance route and import licensing.
Learn more →Singapore HSA
Singapore HSA medical device registration support: classification, route selection, CSDT dossiers, SHARE submissions and dealer’s licences.
Learn more →Thailand FDA
Thailand FDA medical device registration support covering Class 1 to 4 classification, CSDT dossiers and your Thai licence holder.
Learn more →Philippines FDA
Philippines FDA medical device registration support: CMDN and CMDR applications, LTO checks, CSDT dossiers and CDRRHR query handling.
Learn more →Malaysia MDA
Malaysia MDA medical device registration support: classification, CAB conformity assessment, CSDT dossiers, MeDC@St and authorised representative.
Learn more →Not sure which services are right for your device?
Tell us about your product and target markets. We will help you identify the right regulatory pathway.
Book a consultation →