MedDev Experts

MD 15 Licese by CDSCO🔍 Navigating the MD-15 license maze? It's not just paperwork—it's your ticket to legally manufacturing Class C & D medical devices in India.

Under the Medical Device Rules 2017, this CDSCO certification isn't optional—it's MANDATORY. And for good reason: it ensures your products meet rigorous safety standards that protect patients.

The 5-year validity gives you stability, but only if you get through the application process first. Documentation headaches keeping you up at night?

Proper compliance isn't just about checking boxes—it's about accelerating your time-to-market while maintaining quality.

What's your biggest MD-15 challenge? Drop it below!

🇮🇳 ALERT: India's medical device regulations just got a major overhaul!

Thinking of launching your device in the Indian market? The CDSCO has completely transformed the registration process with:

✅ New 4-tier risk classification system
✅ Mandatory SUGAM portal submissions
✅ On-site inspections for higher-risk devices
✅ Risk-based documentation requirements

⏰ Pro tip: Start your registration journey 6-9 months BEFORE your planned launch date. We've seen companies lose millions in revenue due to regulatory delays!

Curious about your specific device requirements? Let's solve your compliance puzzle together - drop your questions below!

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Leading BIS Certification Consultant in Baddi, India. We provide Consultancy for BIS Marking, Product Certification, BIS Registration, & Conformity Assessments
The Bureau of Indian Standards (BIS) is a statutory body responsible for establishing standards for products. The BIS Mark is a certification mark that is awarded to products that meet the quality and safety standards set by the BIS.

BIS Certification is compulsory for certain products in India, such as electrical appliances, food products, and medical devices. It is also recommended for other products, as it is a mark of quality and safety that is recognized by consumers.

If you are interested in getting BIS Marking, Product Certification, BIS Registration, and Conformity Assessments, please contact us today. We would be happy to help you through the process. Our dedicated team is here to answer your questions, provide guidance, and support you throughout the registration process.

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CDSCO License for Self-Testing IVDs in India

Are you a manufacturer or importer of Self-Testing IVDs? The self-testing kits and regents are categorized as in-vitro diagnostic medical devices (IVDs) and are regulated by the Medical Device Rules, 2017.

To manufacture, import, sell, or distribute self-testing IVDs in India, you need a medical device license (MD 5, MD 9, MD 15, or MD 42). This applies to all self-testing kits including Human Chorionic Gonadotropin (hCG), Luteinizing Hormone, Glucose, Glycosylated hemoglobinor its variants, Cholesterol, Follicle Stimulating Hormone (FSH) and Other In-Vitro Diagnostic Medical Devices for Self-Testing.

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Integral CDSCO License for Self-Testing IVDs in India Fastest CDSCO License and Registration for Self-Testing IVDs in India | Get Your MD 5 and MD 9 License for In-Vitro Diagnostic Medical Devices.

CDSCO Import license Consultant for Medical Devices

MedDev Experts is the #1 CDSCO Import License Consultant in India. MedDev Experts helps medical device importers obtain the necessary import licenses from the CDSCO. We provide guidance and assistance throughout the application process, from reviewing the required documentation to submitting the application and following up with the CDSCO.

MedDev Experts helps importers who are new to the Indian market or who are unfamiliar with the CDSCO’s complex import regulations. By working with us, importers can increase their chances of having their import license applications approved quickly and efficiently.

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