Entering the Indian medical device market requires patience and long-term strategy – understanding the regulatory pathway and how much time from the time of submission of application to approval, it would take and also the kind of distribution partnerships is critical. These interconnected steps involve balancing commercial goals with regulatory compliance.
Morulaa HealthTech, one of India’s largest regulatory consultant for Medical Device Registrations with the CDSCO under Medical Device Rules 2017, specializes in guiding overseas manufacturers through this process. As Consultant in both regulatory compliance and distribution strategy, Morulaa helps manufacturers enter the Indian market, and navigate the complexities of medical device registration in India while identifying the right commercial partners.
Finding a Medical Device Distributor in India
Selecting the right distributor is important to build a medical device distribution network in India. The distributor not only drives sales but also acts as the local face of a manufacturer. Morulaa can support manufacturers in finding distributors who work in ENT, Diagnostic Imaging, Wearable Devices, and all healthcare segments in India. Here are the key factors to evaluate:
Turnover and Financial Health: Ensure the distributor has the financial stability and resources to invest in marketing and logistics.
Supply Chain Logistics: Determine whether they are stockists or full-service distributors handling supply chain and logistics.
Sales and Marketing Team: We need to evaluate whether the distributor has a team which know how to meet the doctors and explain the benefits of the devices. Also it is important to check whether they have the experience that matches the price range of products. For example, let’s say the distributor sells products which are typically in the price range of $100 to $500 – these distributors would not have the experience to selling/explain products above $5000 or capital equipment.
Geographic Reach: While it is very common for most distributors to mention that they have a Pan India presence typically in India medical device distributors, work via a sub dealer network. If you plan to partner with such a relationship, then it is important that the master distributor of the medical devices is willing to invest into holding stock. Otherwise, It is always important to see whether they have a direct office in the different cities, at least the major city’s of India such as Chennai, Bangalore, Hyderabad, Delhi, Mumbai.
Product Synergy: Product Synergy, similar to the experience of the marketing team, Product synergy is also important even within the specialisation. For example, a distributor who is dealing with hospital equipment specialising in ICU will be different from a distributor dealing with hospital equipment specialising in the operating theatre, so it is important to make sure that there is a good products energy when you choose a distributor for your devices in India.
Specialization: Indian distributors often specialize by product type or region. For instance, a distributor focused on ventilators may not deal with other ICU equipment, making it necessary to deal with distributors who have experience in working with your products.
Key Accounts and Decision-Makers: Evaluate the distributor’s relationships with key hospitals and their organizational structure to understand their communication with decision-makers.
Morulaa HealthTech offers distributor search services, leveraging in-depth market knowledge and network to identify an ideal partner for your medical devices. We can help manufacturers connect to distributors in Delhi, Mumbai, Bangalore, Hyderabad, Chennai, Kolkata who supply to private hospitals in India(catering to segments such as Respiratory, Gastroenterology, Pediatrics etc).
Regulatory Partner: The Role of an Authorized Indian Agent
While the distributor focuses on sales, the regulatory partner ensures compliance with Indian laws. The role of an authorized Indian agent in medical device registration is important for navigating complex regulatory requirements.
An Authorized Indian Agent Handles
Navigating CDSCO regulations for medical devices
Submitting applications for device registration and approvals
Managing post-market surveillance, adverse event reporting, and recalls
Ensuring compliance with NPPA pricing regulations, plastic waste, and electronic waste management
When selecting a regulatory partner for medical devices in India, consider the following aspects:
Post Approval Compliances: Post-market surveillance, adverse event reporting, and recalls
Import Related Compliances: Compliance with NPPA, waste management laws, and other Indian regulations
Experience with Similar Devices: Ensure the agent has successfully registered medical devices similar to yours.
In-House Capacity: Confirm if the agent has teams to manage imports, logistics, and regulatory submissions.
Long-Term Flexibility: Choose a partner that gives you the freedom to expand or switch distributors without any regulatory burdens.
Morulaa HealthTech, recognized as one of India’s largest regulatory consultant for Medical Device Registrations with the CDSCO under Medical Device Rules 2017. We provide regulatory support for compliance and avoid delays in your market entry. Our understanding of the steps and timelines to register medical devices in India,allow you to register the medical devices in the field of Urology, Neurology, orthopedics etc
Balancing Cost and Business Opportunity
One of the most significant considerations for medical device manufacturers entering the Indian market is balancing cost and expertise. While choosing a low-cost distributor or regulatory partner might seem economical initially, this approach often leads to challenges such as poor compliance and limited market reach.
Morulaa HealthTech strikes a balance between cost and value by offering customized solutions for both distribution setup and regulatory needs. Our in-depth knowledge guide manufacturers through the steps and timelines to register medical devices in India. Our role as consultant ensures that our clients receive precise guidance tailored to their specific needs
Why Partner with Morulaa HealthTech?
Morulaa HealthTech combines over 25 years of experience in regulatory and commercial strategy, making us the ideal partner for entering the Indian medical device market. With a strong local presence and understanding, Morulaa is the trusted partner for manufacturers seeking a smooth and profitable way to enter India’s medical device market. Our support extends to navigating the extremely competitive market in India for various industries such as Dental, Wearable Devices, Pediatrics etc. while providing insights on the impact of government policies on India’s Price Control policies (Eg. cardiovascular stents) in India.For more information, visit Morulaa HealthTech to understand your products market potential and how we can support your commercialisation into India.