Problem Statement:
A Canada based medical device company approached D2R Global Consulting seeking to enter the Indian market. Navigating the complex regulatory landscape set by the Medical Device Rules, 2017 under the Central Drugs Standard Control Organization (CDSCO) was a significant challenge. The client required comprehensive support for regulatory compliance, company incorporation, product importation, and distribution to successfully establish their operations in India.
Our Solution:
D2R Global Consulting was entrusted with delivering end-to-end services to facilitate smooth market entry. We provided:
- Company Incorporation
Secured necessary registrations including Certificate of Incorporation, PAN, TAN, GST, and ESI/EPF, laying the groundwork for legal operations in India. - Trademark Registration
Filed for and secured the client’s brand trademark to ensure market protection. - Medical Device Distribution License
Managed the setup of a local warehouse, submission of Form MD 41, and obtained MD 42 licensing approval from the State Licensing Authority (SLA), ensuring compliance for distribution in India. - Medical Device Import License
Conducted documentation reviews and submitted all required paperwork to obtain the Form MD 15 import license from the CDSCO. - Statutory Compliance
Supported the client with ongoing statutory requirements such as monthly GST filings, income tax filings, and ESI/EPF submissions to ensure continuous regulatory compliance.
Outcome:
With D2R’s comprehensive support the firm is able to manufacture the surgical medical devices in Canada and import into their subsidiary company in India and distribute in India.
