CDSCO Registration for Medical Devices in Brazil
Seamless Entry into the Indian Market with Trusted Regulatory Experts
Are you a Brazilian medical device or IVD manufacturer planning to export to India? To legally sell or distribute medical devices in India, CDSCO registration is mandatory. At Operon Strategist, we specialize in CDSCO consulting services for Brazilian manufacturers, ensuring fast, compliant, and hassle-free approval. With our guidance, you can expand into one of the world’s largest and fastest-growing medical device markets while meeting all Indian regulatory requirements.
What is CDSCO Registration?
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority that governs the import, approval, and regulation of medical devices and IVDs.
Under the Indian Medical Device Rules (MDR 2017):
- All imported devices must be classified, documented, and registered.
- Devices range from Class A (low-risk) products like bandages to Class D (high-risk) devices like heart valves.
For Brazilian exporters, CDSCO registration ensures legal market entry, compliance, and faster product acceptance in India.
Objectives of CDSCO
CDSCO safeguards patient safety and product quality by:
- Approving and regulating imports, manufacturing, and distribution.
- Ensuring compliance with Good Manufacturing Practices (GMP).
- Conducting post-market surveillance and adverse event monitoring.
- Overseeing clinical trials and investigations.
- Aligning Indian standards with global regulatory frameworks.
CDSCO MD Online Registration
India has introduced the CDSCO MD online registration system, a centralized digital platform that makes the registration process faster and more transparent.
For Brazilian exporters, this platform simplifies:
- Application submission via the SUGAM portal.
- Licensing of medical devices and IVDs.
- Faster approval timelines with regulatory efficiency.
CDSCO Medical Device Classification (MDR 2017)
| Class | Risk Level | Examples |
|---|---|---|
| Class A | Low Risk | Bandages, examination gloves |
| Class B | Low–Medium Risk | BP monitors, thermometers |
| Class C | Moderate–High Risk | Implants, catheters |
| Class D | High Risk | Heart valves, stents |
CDSCO Import License Requirements for Brazilian Manufacturers
Since October 1, 2022, CDSCO mandates import licenses for:
- All Class A & B devices.
- All notified Class C & D devices.
Since October 1, 2023, import licenses are required for:
All non-notified Class C & D devices (previously voluntary).
This makes CDSCO registration a mandatory step for Brazilian medical device companies targeting India.
Step-by-Step Process for CDSCO Registration in India
At Operon Strategist, we guide Brazilian medical device companies through every stage:
Device Classification – Identify whether your product is Class A, B, C, or D.
Documentation Preparation – Compile Device Master File (DMF), Plant Master File (PMF), test reports, and labeling.
Appoint an Indian Authorized Agent – Mandatory local representative to interact with CDSCO.
Submit via SUGAM Portal – File applications with all required attachments.
CDSCO Review – Respond to any regulatory queries.
Facility Inspection (if applicable) – For Class C & D devices, CDSCO may inspect your facility.
Grant of License – Receive CDSCO Import License / Registration Certificate.
Post-Market Compliance – Ongoing surveillance, adverse event reporting, and periodic renewals.
Why CDSCO Registration is Important for Brazilian Exporters
- Ensures legal entry into the Indian market.
- Speeds up customs clearance and distribution.
- Assures compliance with Indian MDR 2017 and GMP standards.
- Enhances credibility among Indian hospitals, importers, and distributors.
- Qualifies your products for Indian government and private tenders.
Start Your CDSCO Registration Journey Today
Why Choose Operon Strategist?
Operon Strategist is a trusted regulatory partner for Brazilian manufacturers looking to expand globally. We have extensive experience with Indian regulations (CDSCO, MDR 2017) as well as international frameworks.
Our CDSCO Consulting Services Include:
- Device classification & regulatory strategy.
- Preparation of DMF & PMF technical documentation.
- Indian Authorized Agent support.
- End-to-end submission via the SUGAM portal.
- ISO 13485 compliance and QMS alignment.
- Post-market surveillance & renewal support.
- Global consulting for ANVISA, FDA 510(k), CE Marking, UKCA, SFDA & MDSAP.
We also provide turnkey manufacturing solutions, cleanroom design, and validation consulting for exporters targeting India, the EU, and global markets.
FAQs
Do Brazilian manufacturers need CDSCO registration to export to India?
Yes. CDSCO registration is mandatory for all foreign manufacturers, including Brazil, to import and sell medical devices in India.
Is an Indian Authorized Agent required?
Yes. CDSCO requires all foreign manufacturers to appoint a local regulatory representative in India.
What documents are required?
Device Master File (DMF), Plant Master File (PMF), Free Sale Certificate, ISO 13485 certificate, and test reports.
How long does CDSCO registration take?
The timeline depends on device classification but typically ranges from 3 to 9 months.
Can Operon Strategist support both CDSCO and international approvals?
Yes. We specialize in CDSCO, FDA 510(k), CE Marking, MDSAP, and ISO certifications, offering a one-stop regulatory solution.