Bangalore, often dubbed the tech hub of India, is also emerging as a prime location for medical device import. With its strategic location, robust infrastructure, and proximity to key markets, Bangalore offers a conducive environment for businesses in this sector. Moreover, with CDSCO‘s stringent regulations, having an MD15 Import License is crucial. In Bangalore, the blend of technological advancement and regulatory support makes the process smoother for those looking to secure their CDSCO Import License for medical devices.
It is mandatory to take a CDSCO Import License to import any medical device in India
As per CDSCO’s new guidance, without an import license, a company cannot import Class A, B, C, and D medical devices after the specified deadline for the mandatory Import license (MD 15). This change underscores the importance of timely compliance with Central Drugs Standard Control Organization regulations. Previously, manufacturers could sell their devices in India without many regulations. However, since 2017, a shift occurred. Now, medical devices entering India must adhere to specific import guidelines set by CDSCO. This procedure applies to all importers and distributors bringing medical devices from other countries into India. Moreover, every device needs classification as per CDSCO rules. Official Circular Link
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Pharmadocx Consultants is here for CDSCO Import License Assistance!
- Expertise in CDSCO Regulations: Our seasoned team is adept with the intricacies of CDSCO guidelines, ensuring your application aligns perfectly with all regulatory requirements.
- End-to-End Support: From the initial application process to the joyous moment of license approval, we’re by your side, ensuring every detail is meticulously handled.
- Swift and Efficient: Recognizing the industry’s time-sensitive nature, our processes are streamlined to ensure your application is processed promptly.
- Document Mastery: We assist in preparing and reviewing essential documents, from Plant Master Files to Device Master Files, ensuring accuracy and completeness.
- Regular Updates: Stay informed with consistent updates on your application status, ensuring you’re never left in the dark.
- Post-License Assistance: Beyond just obtaining the license, we offer continued support, assisting with renewals and adapting to any regulatory changes.
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