Trust Built On Regulatory Excellence
-Medtech Regulatory Consulting — India
Artexa delivers end-to- regulatory and compliance solutions in India. Our cost-effective strategies streamline every steps. Leveraging deep expertise in Indian regulations, product development, testing, licensing, Authorised Representative services, and post-market surveillance, we simplfy your regulatory journey so you can launch faster and with complete confidence.
An independent regulatory partner —
Foreign medical device manufacturers entering India face a strict requirement: a registered Authorized Indian Agent to liaise with the Central Drugs Standard Control Organisation (CDSCO) on their behalf. Artexa Lifesciences exists to fill that role with precision — independent of your commercial and distribution partners, so your registration, compliance record, and regulatory data stay entirely under your control.
Uncompromising Data Security & Confidentiality
Independent Authorized Agent —
Avoid distributor conflict of interest
End-to-end lifecycle management
No Hidden Charges
Custom Clearance Support
-Our Regulatory Coverage
Modern Medical Devices, IVD's and SAMD's not just answer to one regulator. Artexa manages compliance across CDSCO, BIS, WPC, Legal Metrology, EPR, AERB, NPPA, DPDP Act, and — so you have one accountable partner instead of Eight separate ones.
— REGULATORY APPROVAL SCOPE
Streamlining CDSCO registrations, clinical evaluation pathways, and global compliance across diverse healthcare technologies and specialized classification tiers.
Medical Devices Registrations
In Vitro Diagnostics (IVDs) Registrations
Software as a Medical Device (SaMD) Approvals
Gain insights into our regulatory services, experience, metrics, case studies, and capabilities for medical devices.
Licensing pathways and case studies for clinical reagents, analyzer hardware, molecular assay kits, and point-of-care rapid testing systems.
Navigate our approval experience for SaMD, IVD SaMD, AI diagnostic algorithms, mobile health applications, cloud platform software.
New/Invetigational Device Approvals
Drug Device Combination Approvals
Veterinary Devices Registrations
Every new device requires unique understanding, support, and expertise. Our dedicated team's capabilities helps simplify your regulatory complexities.
Dual-acting product approval management, including drug-eluting stents, pre-filled auto-injectors, and co-packaged Products.
Compliance and import licensing solutions tailored to animal healthcare instruments, diagnostic kits, and veterinary Medical devices.
We distinguish ourselves with
Outstanding personnel
Artexa regulatory and business managers average at 15 years of experience in the medical device industry
Our experience Artexa team is composed of highly competent, communicative, and knowledgeable staff. This improves quality of our deliverables without any confusion.
Transparant Operations
Navigating medical device registration and importation shouldn't come with surprises. As your independent authorized representative, Artexa delivers total operational transparency—guaranteeing clear timelines, upfront pricing, and zero hidden charges. From market entry to full compliance, you’ll always know your exact progress and costs, just an honest and reliable partnership.
End-to-End Compliance Partner
We don't just file your paperwork and hand over a license—we build, protect, and maintain your entire compliance infrastructure in India.
From initial classification and audit readiness to ongoing post-market surveillance, regulatory updates, and license renewals, we serve as your dedicated in-country partner at every stage of your product's lifecycle.