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Medical Device Import CDSCO India
Overseas medical device manufacturers must follow several steps to obtain an MD-15 Import license. This helps ensure compliance with medical device regulations and customs procedures outlined in the Medical Device Rules, 2017 India by the Central Drugs Standard Control Organization (CDSCO)
The process begins with the compilation of the documents as per the medical device import requirements listed by the CDSCO in India. These files are uploaded via the Form MD14 on the Sugam online portal. A manufacturer cannot upload these files directly and the application can only be made by the local Indian CDSCO Medical Device Authorized Agent or Importer.
Once the MD-14 form and the checklist of documents are submitted, the compiled dossier undergoes review by the CDSCO Inspectors. Any queries raised by them must be addressed promptly to complete medical device registration in India.
Upon successful review, the DCGI at the CDSCO issues a registration and import certificate MD15 (Medical device import license in India), enabling the import of medical equipment and medical devices in India. This process includes ensuring compliance with customs clearance, such as obtaining a No Objection Certificate (NOC) from ADC for import.
The distributor issues a PO to Morulaa for the medical devices. Morulaa will then raise a PO to the Manufacturer who then provides a Proforma Invoice (PI) to Morulaa. Morulaa in turn generates a Proforma Invoice (PI) to the distributor. Financial and commercial discussions, including details about import custom duty taxes on medical equipment in India, are handled directly between the manufacturer and distributor.
Morulaa, as a leading medical device consultancy, has extensive experience as an Importer in managing the process of importing medical devices into India, ensuring smooth and compliant entry of devices.
Morulaa’s in-depth knowledge of licensing, regulations, registration processes and certification requirements ensures efficient compliance with all regulatory requirements and shipping logistics for the medical devices.
Morulaa’s in-depth knowledge of licensing and certification requirements, along with medical device consulting services in India, ensures efficient compliance with regulatory requirements.
Morulaa handles all financial transactions while selling the medical device, ensuring transparency and efficiency. The distributor pays Morulaa, who then pays the manufacturer.
Morulaa acts as a single point of contact, simplifying communication and coordination for manufacturers.
Due to handling large-scale bulk imports, Morulaa can negotiate better rates, reducing overall costs for manufacturers exporting to India.
Morulaa provides comprehensive support to meet the medical device import requirements during customs clearance, including documentation and liaison with customs house agents (CHAs) for the medical devices.
All medical device shipping documents and transactions are shared with the distributor, ensuring complete transparency throughout the process of importing medical devices into India.
Morulaa, as a leading medical device consultancy, has extensive experience as an Importer in managing the process of importing medical devices into India, ensuring smooth and compliant entry of devices.
Morulaa’s in-depth knowledge of licensing, regulations, registration processes and certification requirements ensures efficient compliance with all regulatory requirements and shipping logistics for the medical devices.
Morulaa’s in-depth knowledge of licensing and certification requirements, along with medical device consulting services in India, ensures efficient compliance with regulatory requirements.
Morulaa handles all financial transactions while selling the medical device, ensuring transparency and efficiency. The distributor pays Morulaa, who then pays the manufacturer.
Morulaa acts as a single point of contact, simplifying communication and coordination for manufacturers.
Due to handling large-scale bulk imports, Morulaa can negotiate better rates, reducing overall costs for manufacturers exporting to India.
Morulaa provides comprehensive support during customs clearance, including documentation and liaison with customs house agents (CHAs) for the medical devices.
All medical device shipping documents and transactions are shared with the distributor, ensuring complete transparency throughout the process of importing medical devices into india.
Yes, Morulaa provides comprehensive import services, handling the entire supply chain logistics. Additionally, we offer 4PM services, ensuring seamless support throughout the process. With our unique position and expertise, we simplify the importation process for medical devices into India.
The Bill of Entry is always filed in the name of the authorised Indian agent. This is the name of the local Indian company that has made the application on the Sugam portal on behalf of the overseas manufacturer. It is also the same company listed in the Power of Attorney and MD Fortin legal form.
Yes, there are India-specific labelling requirements:
1. The name and address of the authorised agent must be mentioned.
2. The importer license number must be included.
3. To comply with Legal Metrology and NPPA regulations, the maximum retail price (MRP) must be clearly stated on the label.
Morulaa provides end-to-end support to ensure compliance with these India-specific labelling requirements.
The manufacturer must issue the invoice in the name of the local Indian authorised agent. This is the only entity authorized to make the payment to the manufacturer.
No, only the company listed on the Import License (MD 15) can make the payment to the manufacturer. Sub-distributors or distributors are not authorized to do so.
The invoice should include a detailed product description of the medical device, quantity, unit price, total value, and terms of sale. This document is crucial for customs and financial transactions.
The packing list must itemize all packages, including their dimensions, weight, and contents. This helps in verifying the shipment's contents during customs clearance.
The medical device Certificate of Analysis certifies product quality and compliance with regulations. This document is necessary to meet the medical device import requirements.
The Air Waybill includes preliminary shipment details, such as shipper, consignee, flight details, and handling instructions. It serves as a receipt for the goods and a contract of carriage.
All mandatory medical device documents, including the MD 14 Checklist and the medical device import license, must be confirmed by Morulaa before dispatch. This step ensures that all required paperwork is in order before the shipment leaves for india
During customs clearance, the distributor either connects with Morulaa's Customs House Agent (CHA) or uses Morulaa's CHA in Chennai. This agent assists with the clearing process and provides necessary documentation.
Complete BOE filing and ensure adherence to import regulations, including engaging with a customs house agent (CHA) and confirming the list of medical equipment and medical devices being imported in India. Following the customs duty payment the shipment moves for ADC Customs Clearance.
After ADC Customs Clearance, a tax invoice is issued to the distributor. Local expenses must be settled before dispatch, ensuring all financial obligations are met. The goods are then shipped with an attached invoice and waybill, and the Maximum Retail Price (MRP) is capped at a 10% annual increase.
Partner with Morulaa HealthTech as your Indian CDSCO Agent to be successful in the market. We ensure compliance with the Indian medical device import requirements, offering support for licensing, customs clearance, and post-market surveillance (PMS). We are a consultant in India for medical devices, and support medical device manufacturers to seamlessly navigate the complex import process by the CDSCO and manage the SUGAM account. Utilize Morulaa’s expertise, negotiated rates, compliance knowledge, post market surveillance (PMS) CDSCO India, CDSCO regulations and warehousing capabilities. This collaboration simplifies regulatory and customs procedures, including assistance with post market surveillance (PMS) CDSCO India, ensuring cost-effective and efficient market entry for the importer. By leveraging Morulaa’s comprehensive support, manufacturers can maximize their medical devices’ potential in the Indian market.
