India Market Entry Assistance for a Surgical Dressing Company

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 Approach

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: D2R worked closely with CDSCO officials during the review process, promptly addressing any queries to facilitate a smooth and timely approval.
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.

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India Market Entry Assistance for a Surgical Dressing Company

PROBLEM STATEMENT

Our Approach

Outcome

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