Setting up a Medical Device Business in India

Starting a medical device company in India can be a complex process. We specialize in providing legal counsel tailored to entrepreneurs embarking on the journey of starting a medical equipment business in India.

  • From company formation to regulatory compliance, we provide legal solutions to start your medical equipment business journey in India
  • Stay ahead of import regulations and customs requirements, minimizing delays and ensuring smooth operations for your medical equipment importation activities.
  • Navigate the complexities of obtaining necessary licenses and permits with our support throughout the application process.
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Procedure for Setting Up a Medical Device Business in India

Incorporate Business Entity

Begin by incorporating your business entity through the appropriate legal structure, such as a Private Limited Company, Partnership or Sole Proprietorship. This involves registration with the Registrar of Companies (RoC) under the Companies Act, 2013.

Setting Up Manufacturing Facilities

Businesses intending to manufacture medical equipment in India need to set up manufacturing facilities compliant with relevant regulations. This includes identifying suitable premises, obtaining necessary approvals from local authorities for construction and operation and ensuring compliance with environmental and safety norms.

Intellectual Property Protection

Protecting intellectual property rights related to medical equipment through patents, trademarks, or design registrations is crucial for safeguarding innovation and preventing unauthorized use or replication by competitors. Enforcing legal measures against the infringement of intellectual property rights ensures the exclusivity and value of intellectual assets in the market.

Compliance with Medical Device Rules

Ensure compliance with the Medical Device Rules, which include guidelines for manufacturing, import, and sale of medical devices in India. All medical devices need to be classified and registered as per these rules.

Obtain Industrial License​

To set up a medical device repair business in India, it is crucial to obtain several licenses and registrations. Start by acquiring a manufacturing license and an import license from the Central Drugs Standard Control Organization (CDSCO). Appoint an authorized person as per the Drugs and Cosmetics Act requirements. Secure a warehouse license for distribution and storage, and apply for an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT). Additionally, register your manufacturing unit under the Factories Act, 1948, if applicable. Obtain tax registrations such as VAT, CST, PAN, TDS, and GST from the Income Tax Department and relevant state authorities. Ensuring compliance with these regulatory requirements is essential for legally operating a medical devices repair business in India

Certificate of Compliance

Obtaining a Certificate of Compliance with ISO 13485 is not mandatory for registering a newly notified medical device in India, adhering to ISO 13485 criteria can provide several benefits. As a registered importer or manufacturer, ongoing adherence to ISO 13485 criteria is crucial. Implementing ISO 13485 requirements for setting up, documenting, and executing a quality management system is imperative.
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Documents required for setting up Medical Device Business in India

  • Certificate of Incorporation (for companies)
  • Partnership Deed (for partnerships)
  • Proprietorship Certificate (for sole proprietorships)
  • Application Form (Form MD-3 for manufacturing license)
  • Plant Master File and Device Master File
  • Layout plan of the manufacturing site
  • Details of the manufacturing process and quality control procedures
  • List of equipment and machinery
  • Qualification certificates and experience details of technical staff
  • Application Form (Form MD-14 for import license)
  • Details of the medical devices to be imported
  • Free Sale Certificate from the country of origin
  • Device Master File and Plant Master File of the manufacturing site
  • Authorization letter from the manufacturer (if applicable)
  • Authorization letter designating a responsible person
  • Identification proof and address proof of the authorized person
  • Application Form
  • PAN card of the business
  • Bank certificate or a cancelled cheque
  • Address proof of the business
  • Application Form
  • Layout plan of the factory
  • Consent from the State Pollution Control Board
  • Details of safety measures and equipment
  • PAN card of the business
  • GST registration certificate
  • VAT and CST registration certificates (if applicable)
  • TAN (Tax Deduction and Collection Account Number) registration

These documents provide technical details and evidence of compliance for each medical device. They include device descriptions, specifications, test reports, and certificates showing conformity with relevant standards and regulations. Product registration is necessary to legally market and sell medical devices in India.

These documents establish the legitimacy and suitability of the manufacturing facility or office premises. They include proof of ownership or lease agreements, along with a site master file detailing the infrastructure and facilities available for medical device manufacturing.

Why Choose Us?

Innovative Legal Solutions:

Leveraging our legal expertise and industry insights, we offer innovative and pragmatic legal solutions designed to help medical equipment businesses navigate regulatory complexities, mitigate legal risks, and seize growth opportunities in the Indian market.

Client-Centric Approach

 By truly understanding our client’s business goals and challenges, we develop customized legal strategies and solutions that address their specific needs and help them achieve their desired outcomes.

Legal Expertise

We offer unparalleled expertise in navigating the intricate legal landscape governing medical equipment businesses in India.

Our Team

Ketan Makhija

Senior Partner

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Abhisshek Singlla

Abhisshek Singlla

Partner

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Anish Jaipuriar

Anish Jaipuriar

Partner

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Ankit Bhasin

Ankit Bhasin

Partner

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Work Highlights

Facilitated Multinational Medical Device Company’s Manufacturing Setup in India

Burgeon Law successfully guided a multinational medical device company through the complex regulatory landscape in India, facilitating the seamless establishment of its manufacturing facility. By providing comprehensive legal advice and assistance, including regulatory compliance assessments, licensing procedures, and quality management system implementation, Burgeon Law ensured that the client met all necessary requirements to commence operations in compliance with Indian laws and regulations.

Secured IP Rights for Medical Equipment Manufacturers in India

Burgeon Law assisted a medical equipment manufacturer in protecting their intellectual property rights in India. Through comprehensive IP audits and strategic planning, Burgeon Law identified critical patents, trademarks, and trade secrets vital to the client’s business success. Burgeon Law then implemented robust IP protection strategies, including patent filings, trademark registrations, and confidentiality agreements, safeguarding the client’s innovations and proprietary technology from infringement and misappropriation.

Resolved a Contractual Dispute for a Medical Equipment Manufacturer

Burgeon Law represented a medical equipment manufacturer in resolving a contractual dispute with a local supplier in India. Utilizing their litigation expertise and negotiation skills, Burgeon Law advocated for the client’s interests and pursued swift and favorable resolutions through alternative dispute resolution mechanisms. By providing strategic legal counsel and representing the client’s interests effectively, Burgeon Law helped mitigate potential risks and safeguard the client’s reputation and business interests.

Client Testimonials

Your professionalism, attention to detail, and dedication to ensuring our interests were safeguarded did not go unnoticed. Throughout the process, your team, comprising of Ms Khushboo Jha and Mr Shorya Singhal, demonstrated exceptional communication skills and maintained regular follow-ups with the counterparty. This proactive approach not only expedited the completion of the work but also minimized our involvement, allowing us to focus on other important aspects of our business.

We were particularly impressed by Mr Ketan Mukhija’s ability to handle complex negotiations and legal matters with such ease and efficiency. Your expertise and guidance were invaluable, and we are grateful for the positive outcome achieved.
Mr. Rajesh JainVice President, Swach
Working with the Burgeon Law team was an exceptional experience. They have been our legal advisors ever since the Hocco journey began. Their proficiency in deal management, negotiation skills, insightful counsel and proactive approach to problem-solving were pivotal in ensuring the smooth and timely closure of our investment round. They are not just legal advisors but also strategic partners who bring a wealth of expertise to the table.
Nirali SoniHead - Chona Family Office
Working with Burgeon law as always was a terrific experience. On this deal, Anish and his team demonstrated an unparalleled level of professionalism and dedication in getting the deal done. Their prompt responses and steadfast assistance at every stage of the process were pivotal in ensuring a seamless and timely closure of our investment round. Beyond adeptly managing deal complexities and negotiations, they provided invaluable guidance in navigating critical commercial decisions with sound legal advisory.
Mr. Sanil Sachar Managing Partner - Huddle Ventures
With the expert guidance of Burgeon law, the investment deal was successfully closed. their proficiency in managing the legal paperwork and facilitating discussions among multiple stakeholders was crucial. Their dedication ensured a smooth and efficient process, marking a significant milestone for all parties involved.
Mr. Vijay Sharma Founder - Fabriclore
Roma and her team at Burgeon Law blend business practicalities within legal boundaries and create implementable outcomes. They keep a professional, yet thorough and balanced approach while negotiating with an Investor. Their availability and ability to think on their feet sets them apart from other firms. They are always mindful of the kind of assistance required by businesses at different stages, which makes their advice bespoke and highly customized. Working with them was an evolving exercise and we look forward to more future projects together.
Ashish KashyapFounder - INDMoney
I have worked with Ketan in Srei Equipment Finance Limited on a range of legal challenges related to our business of equipment leasing and receivables purchase. Ketan had an exceptional ability to balance between retaining our legal advantages and providing a solution for practical business and commercial deadlocks. I look forward to working with him again.
Vineet Pasari Founder and CEO at Assetz Finanz
I have worked with Roma and her team over 100 different transactions over the last decade. Burgeon Law with a team of maestros who understands the requirements of both startups and investors. They have a blend of Legal and Technology with deep knowledge of the tech ecosystem and have experience of managing transactions of different sizes and complexities.
Rajesh SawhneyFounder & CEO - GSF Accelerator
Biryani By Kilo has immensely benefited from our association with Burgeon Law. Other than great legal advice, Roma and her team with their sensitivity and understanding of legal challenges of our industry assisted as a great partner in the growth of Biryani by Kilo. Best wishes for great success to them.
Vishal Jindal Founder -Biryani By Kilo
I have known Ketan to be a proactive solution oriented counsel who is known for his ability to offer balanced advice in a deal which makes him a preferred counsel not only for his clients but also amongst other parties in the deal. His ability to foresee the risk parameters and to provide for a mitigation mechanism is definitely praiseworthy.
Varun KhandelwalDirector at Buller Capital Pvt Ltd
Roma is able to look at the issues both at macro as well as micro level; and has always been able to come up with implementable strategies. Her understanding of tech space is deep and nuanced, which is reflected in the strategic inputs she provides. We have the confidence of reaching out to her because she is dependable and has a robust team to provide end-to-end support. They are our go-to support system and we found their assistance during the fund-raising process absolutely trustworthy, proactive and forward moving with a remarkable turnaround.
Radhika GhaiFounder - Kindlife, Ex Co-Founder - Shopclues
AngelList India’s experience with Burgeon Law has been nothing short of spectacular. The way they’ve handled our fast-paced deal-making and took over our entire legal process including entrepreneurial approach towards transactions, tracking, negotiation, immediate feedback loops, and diligent turnarounds. I’d recommend them to anyone who wants in on our secret to quick closures.
Utsav SomaniPartner - AngelList India
Ketan is one of the most efficient and thorough corporate legal counsel who would provide an expert and articulate advice across a plethora of business situations.
Sourav DaspatnaikChief Executive Officer, Swach Environment Private Limited
The team at Burgeon Law works with an outcome-oriented approach, which helps them plan the course of action and strategy from the very beginning. Especially for start-ups, they understand their specific issues extremely well. Once we started working with them, they have advocated and protected our interests - both from the perspective of a startup organization as well as in individual capacity of the founders. We have been satisfied with the way they have negotiated effectively with investors and at the same time recommended solutions and workarounds to make sure the process keeps moving forward. They are super quick which is much needed for any startup or investor.
Sachin BhatiaFounder - BulBul, Ex Co-Founder - MakeMyTrip
Throughout our transactions, Burgeon Law provided practical solutions rooted in sound law that also made complete commercial sense and acted as a catalyst to the transaction. The firm also has an undisputed penchant for delivering on consistently efficacious timelines, again saving considerable amounts of cost on the transaction. I can see that it taps into its reservoir of experience working with a large volume of growth stage start-ups. They are able to anticipate the life cycle of issues that will arise, and act to be one step ahead always.
Samir SoodFounder - Venture Highway
I have no hesitation in recommending Ketan Mukhija. The legal support Ketan has provided to Vikram Solar has been excellent. Ketan works extremely hard, is responsive to all requests no matter the deadline, and is very detailed and thorough in his approach. He not only gives constructive and expert legal opinion, but also grasps the business implications of his counsel and as such his work is particularly significant in ensuring best value for VSL in contract negotiations and other legal matters. Ketan has been a pleasure to work with and I look forward to continuing the partnership with VSL.
Anil LadhaHead - Corporate Finance, Vikram Solar Limited
Roma has been doing spectacular work to build a strong legal ecosystem and culture for the startups and funds across multiple jurisdictions. Her team at Burgeon Law has contributed to the evolution of the startup sector and have earned a formidable reputation for being preferred service providers for market-leading venture capital & growth equity investors, as well as pioneering founders and companies.
Rishab Malik, Venture PartnerJungle Ventures, Ex-Co-founder - Droom.in
Roma with her team is one of the finest law firms for Startups and Investors in the country. I have had the pleasure of working with them! They bring in-depth understanding of the tech/start-up ecosystem market and advise with a focus to get the deal done. They are extremely responsive, flexible and have the mindset of a start-up entrepreneur. I highly recommend Roma and the team for start-ups and funds at all stages!
Ashish TanejaPartner - growX Ventures
Ketan is an astute corporate lawyer. He has a deep understanding of corporate law and data privacy law. He is also a start-up enthusiast and actively involved in the ecosystem. He is also always up for pro bono service to NGO, entrepreneurship bodies, or any other social causes. I wish him all the best!
Wasim KhanCo Founder, Zotalabs
Roma and her team at Burgeon Law have advised Lumikai on several transactions over the course of the last 18 months. As transaction lawyers, they are able to maintain a fine balance in providing pragmatic commercial advice alongside sharing sound legal judgment, which is so valuable. We have always been impressed with their methodical, high-quality work product, personalized attention, and prompt turn-arounds especially in time-sensitive matters.
Salone SehgalFounding General Partner - Lumikai Fund
Deal Making is complex and time consuming. Having a partner like Burgeon Law by your side makes the entire process streamlined and hassle-free, including legally structuring deals, negotiating legal nuances within contracts, and supporting with full range of documentation. Since 2015, Burgeon Law has been a true partner to Powerhouse.
Sri PedduManaging Director - Powerhouse Ventures
Burgeon Law with an exceptional team have always been very responsive and make sure to keep the balance of Investors and Founders need and demand.
Manu Rikhye Partner - Merak Ventures
The Burgeon team has a deep understanding of the nuances of startups. They solve problems with a practical mindset, something that is still missing in the current ecosystem. We’ve had a great experience working with them across multiple transactions.
Nandan VenkatachalamPrincipal - Axilor Ventures
Kae has been delighted to have Burgeon Law as its transaction advisor. Very professional approach and highly responsive team. They provide end-to-end advice and support on any transaction. With their practical approach, many deal-breaker situations are sorted out easily.
Madhura SardarLegal Head - Kae Capital
Over the years, we have worked with Burgeon Law for various transactions, corporate commercial requirements, and strategic legal advisory. We are a high-growth company always working with aggressive deadlines and the Burgeon team has always made sure to complete the project as per our timelines even if it required them to align with multiple stakeholders to make it happen. We are always pleased with the quick & strategic support and feedback we get from them to safeguard our long-term interests in our company. Rusk and the team will definitely be working with the same team for our next fundraiser, hopefully very soon!
Mayank Yadav CEO - Rusk Media
Working with Burgeon Law was an excellent months-long lesson "101 on how to invest in India". Burgeon Law not only guided us through legal issues, but also helped us navigate problems we didn't know existed
Sasa VucinicManaging Partner and CoFounder, North Base Media Fund
Roma is one of the best corporate lawyers that I have ever worked with. Not only is she a legal eagle but she is a master business negotiator often pacifying both sides to reach a suitable understanding. Backed by a super team, her firm provides reliable and efficient services.
Ashish ChandFounding Partner - Nueva Capital
Extremely happy with the Burgeon Law Team. They have been diligent with the paperwork and making sure all the compliances/ Statutory requirements are fulfilled. This makes it easy for us as a Company.The team was very prompt during our Transaction Process and while the drafting of the contracts. We did not have to follow up and the Burgeon team provided everything on time.They have been very clear with their drafting skills which made it simple and uncomplicated throughout the process.
Sangmesh JattiCFO - Heads Up For Tails
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FAQs

When considering setting up a medical equipment business in India, Burgeon Law emerges as the premier choice due to its unparalleled expertise, client-centric approach, and proven track record of success in the healthcare sector. With a deep understanding of the complex regulatory landscape governing medical device businesses in India, Burgeon Law offers comprehensive legal solutions tailored to meet the unique needs and challenges of its clients.
Starting a medical equipment business in India requires obtaining licenses from regulatory bodies like the CDSCO and protecting intellectual property. Additionally, drafting commercial agreements, conducting due diligence, and maintaining ongoing regulatory compliance are crucial. Expert legal guidance is essential for navigating these requirements and ensuring a smooth and successful establishment in the Indian healthcare market
We can assist with the registration process for a Medical Equipment business by providing comprehensive legal guidance and support at every step. Our team of experienced professionals specializes in navigating the complex regulatory landscape governing the medical device industry in India. We begin by conducting a thorough assessment of your business requirements and objectives, identifying the specific licenses and approvals needed from regulatory authorities such as the Central Drugs Standard Control Organization (CDSCO). We then assist in preparing and submitting all necessary documentation, including license applications, quality management system certifications, and product registration materials.
Absolutely, we specialize in assisting Medical Equipment businesses with securing intellectual property (IP) rights in India. Our team of legal experts is well-versed in the intricacies of Indian IP laws and regulations, offering comprehensive guidance tailored to your specific needs and objectives. We begin by conducting a thorough assessment of your innovations, technologies, and brand assets to determine the most appropriate IP protection strategies. This may include filing patent applications to protect novel inventions, registering trademarks to safeguard your brand identity, and implementing measures to protect trade secrets and proprietary information.
We provide comprehensive support to Medical Equipment businesses with their ongoing legal and compliance needs, ensuring continued adherence to regulatory requirements and industry best practices. Our dedicated team of legal professionals offers proactive guidance and assistance across a range of areas, including regulatory compliance, quality management, and contractual obligations. We help businesses stay up-to-date with evolving regulations and standards, conducting regular assessments to ensure compliance with laws governing medical devices in India.

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