Introduction – Import of Medical Devices into India
This article deals with the import of Medical Devices into India. The Medical Devices importer in India is of prime importance for every manufacturer. In order to import into India, manufacturers have to meet a certain standard of quality and efficacy to enter the Indian market. The Import, Manufacture, Distribution and Sale of Drugs, Cosmetics, Medical Devices and IVDs in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The central Government monitors regulatory control over these articles imported into the country through the Central Drugs Standard Control Organization (CDSCO) overlooked by the Drugs Controller India (DCG). The Most important objective for Medical device registration and Importation in India is to ensure availability of secure, potent and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices. The Documentation required importing medical devices must adhere to these standards to facilitate seamless market entry.
Importation Services
Morulaa is an Independent Authorized Representative for several manufacturers and we give complete support to Overseas Manufacturers for the import of their Medical Devices into India. The Medical Device Rule 2017, India governs these processes to ensure compliance and regulatory adherence. Previously, prior to 2018, the license holder could be a single company and several companies could have a separate Import License. However, from 2018, the Importer and the License Holder have to be the same company. Obtaining a medical device import license India is now an integral part of the process, ensuring that the importer is responsible for ensuring smooth customs clearance and compliances have to be met with regards to the import of the Medical Devices into India.
Principle of Functioning
- The Authorized Representative order EXW price to the Company
- The Company supplies an EXW proforma invoice to the Authorized Representative
- The Authorized Representative pays the EXW Pricing to the Company based on the Payment Terms.
- Verification of the following documents must be done by the Authorized Representative prior to dispatch
- Airway Bill (AWB) – The Authorized Representative’s details must be mentioned correctly as per the Registration Certificate
- Commercial Invoice – Correct details of the Name of the Company and Products in the invoice must be as per the Registration Certificate.
- Packing List – The dimensions of the package in the Packing List and AWB must be the same.
- Certificate of Conformity (COC) – The product shelf life must be as per the CDSCO rules and must be verified by the Authorized Representative
- Once the consignment is dispatched and lands into India, all local processes are done by the Authorized Representative. The local processes include
- Authorized Representative must supply the following documents to the Clearing and Forwarding Agent (CHA)
- Airway Bill (AWB)
- Commercial Invoice
- Packing List
- ADC Sheet
- Registration Certificate
- Product Description
- Product Brochure
- Batch Release Certificate
- End User Certificate
- GATT Form
- Importer Label
- Importer Exporter Code
- AD Code
- GST Certificate
- Wholesale Drug License
- The CHA generates the Checklist Bill of Entry (BOE) which must be verified by the Authorized Representative. The duty structure, company details, packaging details etc must be verified.
- Once the Checklist BOE is confirmed, the Bill of Entry (BOE) is generated for duty filing.
- The BOE to be filed either in advance or on arrival. If not done on time, demurrage would be attracted.
- Duty must be paid on the online Ice Gate Portal
- After the duty has been paid, customs examines the goods to give an Out of Charge (OOC)
- Once the OOC has been generated, the Authorized Representative can collect the Package
- Authorized Representative must supply the following documents to the Clearing and Forwarding Agent (CHA)
Conclusion
In India, CDSCO authorized agents are required to be involved in the import and customs clearance process for Medical Devices, Cosmetics and IVD for which they hold an import license. Morulaa is committed to fair, efficient and transparent import procedures. As a Medical device CDSCO authorised Agent in India, Morulaa’s basic support includes taking title to your Package through customs clearance and ensuring safe delivery into India by adhering to the regulations under the Medical device Rule 2017, India, and ensuring all compliances are met. We also offer Local Storage and Warehousing for your Medical Devices into India. Please contact Morulaa for more information on Import of your Medical Devices into India.
- Authorized Representative must supply the following documents to the Clearing and Forwarding Agent (CHA)
- Airway Bill (AWB)
- Commercial Invoice
- Packing List
- ADC Sheet
- Registration Certificate
- Product Description
- Product Brochure
- Batch Release Certificate
- End User Certificate
- GATT Form
- Importer Label
- Importer Exporter Code
- AD Code
- GST Certificate
- Wholesale Drug License
- The CHA generates the Checklist Bill of Entry (BOE) which must be verified by the Authorized Representative. The duty structure, company details, packaging details etc must be verified.
- Once the Checklist BOE is confirmed, the Bill of Entry (BOE) is generated for duty filing.
- The BOE to be filed either in advance or on arrival. If not done on time, demurrage would be attracted.
- Duty must be paid on the online Ice Gate Portal
- After the duty has been paid, customs examines the goods to give an Out of Charge (OOC)
- Once the OOC has been generated, the Authorized Representative can collect the Package