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.

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

Abhisshek Singlla

Abhisshek Singlla

Partner

Anish Jaipuriar

Anish Jaipuriar

Partner

Ankit Bhasin

Ankit Bhasin

Partner

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

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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