CDSCO Import Registration (Form MD-15)

Form MD-14 is the application; Form MD-15 is the licence you receive. The MD-15 names the foreign manufacturer, the manufacturing site, the Authorized Indian Representative, and the exact list of devices covered. That specificity matters. If you add a new device from the same site later, it can often be endorsed onto the existing licence, but a different manufacturing location or a separate legal manufacturer needs its own application from the start.

A common misconception is that one licence covers a brand. It does not — it covers a manufacturer-site-device combination. We spend time up front mapping your product portfolio against your sites so the grouping is efficient and defensible, which keeps both your government fees and your paperwork down.

The AIR is the legal face of your product in India. They hold the licence, receive regulatory correspondence, and are accountable to CDSCO for the device once it is on the market. Because the AIR name is tied to the registration, switching representatives later means transferring or re-filing the licence — an avoidable headache if you pick a stable partner at the outset.

When we act as your AIR, we hold the required wholesale drug licence, manage the SUGAM account, and stand between you and the department for every query, inspection request and post-market notification. You keep control of your product; we carry the local regulatory load.

• AIR must hold a valid wholesale drug licence (Form 20B / 21B).
• AIR receives and answers all CDSCO correspondence for the licence.
• Changing AIR later requires a formal licence transfer — choose carefully once.

Three documents decide most import applications. The Device Master File describes the device in full — design, materials, manufacturing, verification and validation, biocompatibility to the ISO 10993 series, and a risk file to ISO 14971. The Plant Master File documents the site that makes it. And the Free Sale Certificate proves the device is already sold legally in your home country. Add your ISO 13485:2016 certificate and labelling that meets Schedule VI, and you have the backbone of the dossier.

Where applications stumble is consistency: a DMF that claims one shelf life and a label that shows another, or a Free Sale Certificate that names a slightly different manufacturer than the application. Reviewers notice these mismatches immediately. We cross-check every document against the others before filing, and we guide you through the legalisation and apostille steps your home paperwork usually needs.

An MD-15 import licence typically takes six to nine months from filing to grant, with the biggest swing factor being how fast technical queries are answered. Government fees depend on the device class and the number of devices and sites on the application. The good news at the end: once granted, the MD-15 has perpetual validity as long as the retention fee is paid on time and the device, manufacturer and site details stay unchanged.

• Typical timeline: 6–9 months, driven mostly by query turnaround.
• Fees scale with device class and the number of devices/sites.
• MD-15 is perpetual once granted, subject to the retention fee.
• Bringing in samples first? That needs a separate test licence.

Getting the MD-15 is not the finish line — it is the start of an ongoing relationship with the regulator. The licence stays alive only if the retention fee is paid before it lapses, and a missed retention date can force you back to a fresh application, which is a painful way to lose a perpetual licence. We track these dates so a diary slip never costs you your registration.

Real products also change over their life. A new variant, a revised label, a shifted manufacturing line, a change of Authorized Indian Representative, or an updated shelf life all need to be intimated to CDSCO, and some require a formal endorsement or variation before you can act on them commercially. Treating these as afterthoughts is how importers end up with a licence that no longer matches what they are actually shipping — a gap that surfaces at the worst possible moment, during a customs check or a post-market query.

India also runs a materiovigilance programme for medical devices, and licence holders are expected to report serious adverse events and field safety actions. We set up a simple process so your team knows what to report and when, keep your dossier aligned with the product as it evolves, and handle the department for every variation — so the licence you worked months to get keeps doing its job.

The delays we are called in to rescue almost always come from the same few places. Someone files each device as its own application when a single grouped licence would have covered the range, tripling the fees and the review load. Or the Free Sale Certificate names the manufacturer slightly differently from the application, and the whole file stalls on a mismatch that took thirty seconds to create. Or the labelling was never checked against Schedule VI, so the device clears technical review only to be caught at the labelling stage.

None of these are difficult problems — they are just easy ones to miss when an overseas team is filing into an unfamiliar system for the first time. We catch them before submission because we have seen each of them stall a licence, and a few hours of cross-checking at the start routinely saves months at the back end.

A device can have a flawless technical dossier and still be held at the port because of its label. Schedule VI of the Medical Devices Rules sets out exactly what an Indian label must carry — the importer’s name and address, the import licence number, manufacturing and expiry details, and clear identification of the device — and a label that was designed for the US or EU market rarely satisfies all of it out of the box. Customs and drug inspectors check labelling closely, and a non-compliant label is one of the most common reasons a legitimately registered device gets detained.

We review your existing artwork against the Indian requirements early, well before the first shipment, and give you a marked-up label that will clear inspection. It is a small, unglamorous piece of the job that quietly prevents one of the most frustrating kinds of delay — the shipment that has cleared every technical hurdle only to sit at a port over a printing detail.