India Customs Clearance: MD-15 Verification and Labelling

1. Key takeaways

Clearing medical devices at an Indian port of entry rests on three essentials: a valid Form MD-15 import licence (or the online registration number for Class A exempt products), the importer’s own licence eligibility (MD-42 / wholesale licence / manufacturing licence), and labelling that complies with Chapter 6. If any one of the three is missing, the consignment may be detained at the port.

• Three essentials, not one: the product-level licence does not substitute for the importer-level licence, and neither substitutes for compliant labelling.
• Sticker labelling is permitted: the importer may add the import licence number, importer details and manufacturing details by labelling after arrival.
• Shipping documents are statutory: the invoice or statement and the package insert are required by Rule 38(1), not merely by commercial practice.
• Class A exempt products use a registration number: they have no MD-15, so the online registration number is the document to present.

2. Legal basis

The requirements come from Chapter 5 of the MDR 2017, Rule 44 on labelling, Rule 38(1) on accompanying documents, and the CDSCO FAQ. The table consolidates the points that a customs broker will actually check.

3. Expert insights

Insight 1: clearance risk most often fails on importer eligibility. An MD-15 can be in place and the goods can still be refused entry because the importer itself does not hold an MD-42. The certificate and the licence-holding entity are two different things. This distinction is invisible on the licence document and only emerges when the broker asks for the importer’s own registration. The result is a consignment sitting at the port while the paperwork is sorted out, which is both costly and avoidable.

Insight 2: sticker labelling is the most practical tool at the clearance stage. The overseas manufacturer does not need to print separate packaging for India: after arrival, the importer may sticker-label the import licence number, the importer’s name and address, the actual manufacturing site address and the date of manufacture. This satisfies Rule 44(n) while avoiding a packaging revision at the overseas plant. The practical benefit is that a single global packaging design can serve the Indian market, with the India-specific information added at the point of import rather than at the point of manufacture.

Insight 3: the accompanying documents are a legal requirement. Rule 38(1)(ix) expressly requires the consignment to be accompanied by an invoice or statement showing the name and quantity of the devices, and Rule 38(1)(x) requires a package insert or user manual. These two are often treated as commercial paperwork and overlooked, yet they are conditions of the licence. Their absence gives the port authority a reason to hold the consignment that has nothing to do with the product itself.

Insight 4: Class A exempt products rely on a registration number at clearance. There is no MD-15 for these products; the document presented is the registration number generated by the online portal. A customs broker unfamiliar with this form can misread it as an unlicensed import, which is why the document set should be explained to the broker before the first shipment. Once the broker has seen the format, subsequent consignments clear on the same pattern.

4. Practical recommendations

• Prepare a clearance document pack for every Indian client. GRZAN prepares a clearance pack containing: a copy of the MD-15 (or the Class A registration number page), a copy of the importer’s MD-42 or wholesale licence, the sticker-label artwork with placement instructions, an invoice template carrying the device name and quantity fields, and the package insert or user manual.
• Send the pack to the customs broker for pre-review. We send this pack to the client’s broker for a pre-review so that the documentation position is aligned before the first consignment arrives, avoiding the knock-on delays caused by a first-shipment detention.
• Check model coverage before each shipment. The MD-15 must cover every model in the consignment, not only the models most often shipped.
• Keep sticker placement documented. The artwork and the placement instruction should be held by both the importer and the manufacturer so that the same version is applied consistently.
• Maintain a separate file for Class A exempt products. Because the document is a registration number rather than a licence, it is easily lost between the other licence files.

5. Verification checklist

• □ The MD-15 is valid and covers all models in this consignment
• □ The importer holds one of: MD-42 / wholesale licence / manufacturing licence
• □ The sticker-label artwork includes the import licence number, importer name and address, actual manufacturing site address and date of manufacture
• □ The accompanying invoice includes the device name and quantity
• □ The package insert or user manual accompanies the goods
• □ The online registration number page is ready for Class A exempt products

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com