CDSCO registration, done properly.

Under the Medical Devices Rules 2017, all medical devices sold in India must be classified as Class A (low risk), B (low-moderate risk), C (moderate-high risk), or D (high risk). The classification determines the depth of technical documentation required, the applicable conformity assessment route, and the timeline to approval. Getting classification right at the outset avoids costly re-submissions.

We review your device against the classification criteria in Schedule II of MDR 2017, assess whether any in-vitro diagnostic or active implantable provisions apply, and confirm the applicable conformity assessment procedure under Schedule V. Where a device straddles categories — common with combination products or software as a medical device — we provide a defensible written rationale before any submission.

For devices already CE-marked or FDA-cleared, we assess whether a fast-track route under Rule 30B applies and what additional India-specific data is needed. For novel devices without a global reference, we map the most efficient path through Rule 8 or Rule 9.

CDSCO submissions are made through the SUGAM portal (sugam.gov.in). The portal has its own document format requirements, file size limits, and category-specific form structures — minor deviations cause rejection at intake without substantive review. We prepare all submission documents in SUGAM-compatible format, manage the application lifecycle, and respond to CDSCO queries during technical review.

A Class C or D submission typically requires an Essential Principles Checklist (Schedule III of MDR 2017), a full clinical evaluation report, performance testing data, post-market surveillance plan, biocompatibility evidence per ISO 10993, and risk management documentation per ISO 14971. We draft, compile, and quality-check each element. For Class A/B devices, we prepare the lighter documentation set required under Rules 7 and 8.

Import licences (Form MD-14) and manufacturing licences are coordinated with the relevant State Licensing Authority where needed. For companies without a registered Indian entity, we structure loan licence arrangements under Rule 37 with licensed Indian manufacturers who can hold the licence on behalf of the foreign manufacturer.

Every medical device imported into India for sale must have a valid import licence under Form MD-14, issued by CDSCO. The application requires a local authorised representative or licensed importer. Where the foreign manufacturer does not have an Indian subsidiary, the import licence is held by an Indian entity — either an independent importer or a loan-licensee — and the foreign manufacturer must authorise that entity through a formal appointment letter.

Class A and B non-sterile, non-measuring devices notified under the Rules are exempt from import licensing but still require declaration of conformity. We advise on which notification category your device falls under and whether any licence exemption applies, avoiding unnecessary applications for exempt products.