CDSCO Medical Device Registration in India

Every medical device registration in India starts with the same question, and most delays trace back to answering it carelessly: what class is this device. Get the classification wrong and everything built on top of it — the licensing authority, the application form, the supporting dossier, the review timeline — is built on the wrong foundation.

This is a general walk-through of how registration works under the Medical Device Rules, 2017 (MDR 2017), the framework CDSCO administers for devices sold or imported into India. It is written for teams planning a filing, not as legal advice. Specific classification and licensing decisions should be confirmed against the current Rules and, where the boundary is unclear, with the licensing authority directly.

Classification sets the rest of the path

MDR 2017 groups devices into four risk classes — A, B, C and D — using rules based on intended use, degree of invasiveness, duration of body contact, and whether the device is active or implantable. Class A covers low-risk devices, Class D covers the highest-risk category such as implantable and life-sustaining devices, and B and C sit in between.

The classification rules are written as a set of criteria applied in sequence, not a lookup table of device names. Two devices that look similar on the surface can land in different classes because one is invasive and the other is not, or because one is intended for long-term contact and the other for transient use. Where a device could plausibly sit in more than one class under different rules, the higher class applies. Documenting the classification logic — which rule was applied and why — is worth doing properly at this stage, because it is the first thing a reviewer checks and the hardest thing to redo cleanly later.

Manufacture versus import: two different licences

The Rules separate the licence for manufacturing a device in India from the licence for importing one, and the two follow different authorities and forms.

For devices manufactured in India, Class A and B applications generally go to the State Licensing Authority, while Class C and D applications go to the Central Licensing Authority — CDSCO, acting through the Drugs Controller General of India (DCGI). For devices manufactured outside India and brought in for sale or distribution, the import licence is a central-authority function regardless of risk class, applied for and granted through CDSCO.

The import route: MD-14 and MD-15

An importer applies for an import licence on Form MD-14, filed through the CDSCO online portal along with the prescribed fee. If the application and supporting dossier are found in order, the licence is granted on Form MD-15. The MD-14/MD-15 pair is specific to import; it does not substitute for a manufacturing licence if any part of production also happens in India.

A complete MD-14 filing typically includes a device master file, a plant master file for the manufacturing site, evidence of a certified quality management system (commonly ISO 13485), a free sale certificate or equivalent market-authorisation evidence from a reference regulator, test reports against applicable essential principles, and product labelling and instructions for use consistent with Indian requirements. For higher-risk classes, clinical evidence appropriate to the device and its intended use is expected as well.

The classification decision and the dossier that supports it are worth getting right before filing, not during query response. A query on classification does not just add a review cycle — it can send the application back to a different form and a different authority.

Timelines are indicative, and queries are normal

CDSCO's processes carry indicative review periods, but an incomplete or inconsistent dossier generates queries, and each query round resets the practical clock rather than the published one. The realistic planning assumption is that the dossier's internal consistency — classification, master files, test reports and labelling all telling the same story about the device — determines the timeline far more than the calendar on the form does.

Post-approval obligations do not end at the grant. Registered devices are expected to be tracked for adverse events and quality complaints through the applicable post-market surveillance and vigilance requirements, and material changes to the device, its manufacturing site, or its labelling generally require the authority to be informed rather than assumed to be covered by the original approval.

Before the application is filed

A short list of questions worth settling early: which classification rule genuinely governs this device, and is that logic written down in a form a reviewer can follow. Is the route manufacture, import, or both, and does the dossier match that route rather than a generic template. Is the quality management certification current and does it cover the actual manufacturing site named in the application, not a related but different facility.

None of this replaces a proper regulatory assessment of a specific device, and nothing here should be read as a guarantee of a particular classification, licence, or timeline — those depend on the device and on CDSCO's review. If you are working through a classification call or an MD-14 filing and want a second set of eyes on the dossier, our CDSCO approvals team can walk through it with you.