Welcome to Vericert

Your Trusted Medical Device Licensing Consultant

At Vericert, we specialize in providing comprehensive consultancy services for Medical Device Licenses and certifications to ensure your products meet national and international regulatory standards.

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Medical Device Licensing services

Manufacturing Licenses
Import Licenses
Sales & Distribution Licenses
Clinical Investigation & Performance Evaluation Licenses
Other Regulatory Approvals
health
about

Indian Medical Device Rules – Glimpse

In India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017, issued by the Ministry of Health and Family Welfare via Notification No. G.S.R, 78(E) issued on 31st January 2017.

The Indian Medical Devices Rules 2017 are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices. The Indian Medical Devices Rules 2017 consists of 12 Chapters, 8 Schedules, and 40 Medical Devices.

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Ms. Sneha Modi

Director, Vericert

Master in Pharmacy

Ms. Sneha Modi ( Director, Vericert - Master in Pharmacy )

Ms. Sneha Modi is a seasoned professional with 15 years of experience in the pharmaceutical, medical device, and clinical research sectors. She has made significant contributions to the industry, specializing in medical device consultancy and auditing various ISO standards.

Expertise and Achievements:

Proficient in providing strategic consultancy for medical device regulations and ensuring compliance with global standards

Extensive experience in auditing and certifying organizations across a spectrum of ISO standards such as ISO 13485, ISO 9001, and other quality management systems.

Proven ability to guide companies through regulatory pathways to achieve compliance, enabling efficient market access for medical devices.

Deep understanding of pharmaceutical practices and clinical research methodologies, ensuring robust quality and regulatory alignment.

Ms. Sneha Modi's leadership at Vericert reflects her commitment to promoting excellence in quality management systems and fostering innovation in the pharmaceutical and medical device industries. Her vast expertise has been instrumental in driving client success and upholding global compliance standards.

Vision:
As a Director at Vericert, Ms. Modi envisions empowering organizations with the tools and guidance required to maintain the highest standards of quality and compliance, ensuring their competitive edge in the global marketplace.

We Are Offer

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Manufacturing Licenses

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Import Licenses

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Sales & Distribution Licenses

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Clinical Investigation & Performance Evaluation Licenses

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Other Regulatory Approvals

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Our Expertise

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1. Medical Device License Consultancy (MD-5, MD-9)

We assist manufacturers and distributors in obtaining Medical Device Licenses as per CDSCO guidelines, including:

MD-5: Manufacturing License for Class A & B Medical Devices.

MD-9: Manufacturing License for Class C & D Medical Devices.

MD-42: Wholesale/Distribution License for Class A & B, C & D Medical Devices.

Our team ensures seamless documentation, regulatory compliance, and support throughout the process, enabling you to achieve timely approvals.

2. ISO Certification

Vericert helps you attain ISO 13485:2016 certification – the global standard for Medical Device Quality Management Systems. We guide organizations in implementing quality systems that ensure safety, efficiency, and product consistency.

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3. CE Marking for Medical Devices

We provide expert guidance to obtain CE Certification for medical devices, ensuring your products comply with the European Union's Medical Device Regulations (MDR) and can be sold in the European market.

Why Choose Vericert?

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Regulatory Expertise

A team of experienced professionals well-versed in CDSCO, ISO, and CE certification processes.

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End-to-End Support

From documentation to approvals, we simplify the licensing journey.

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Client-Centric Approach

Customized solutions tailored to meet your specific business needs.

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Timely Delivery

Efficient processes to help you achieve regulatory compliance on time.

Client Feedback

Words from Our Clients

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David Patel
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David Patel
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Koria Morgan
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Michael White
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