The growth story of India is well-known while manufacturers understand the opportunity that the large growing population possesses along with the increase in GDP. On the other side, the cultural nuances of the different regions of India make it difficult for an overseas manufacturer to establish themselves in the market. Partnering with Morulaa HealthTech, a leading medical device consultant in India, we can provide the guidance needed to navigate these challenges. Morulaa is one of the largest Indian medical device consultant with a combined experience of over 25 years in medical device regulatory approval and distribution in India.
Here are some key factors to consider before entering the Indian medical device market:
1. Regulatory Compliance for Medical Devices in India
Our Consultants at Morulaa HealthTech go through your product details and check if the products meet India’s regulatory requirements as the first step. The Central Drugs Standard Control Organization (CDSCO) is the Indian Regulatory body under which Medical Devices are registered as per the Medical Device Rules, 2017.
For manufacturers who are looking to enter India, this process can be time consuming without the right partner. Morulaa HealthTech, known for its expertise in medical device registration processes in India, can help you streamline the application for import licenses (MD-14) through the CDSCO’s SUGAM portal. With its experience in managing regulatory compliance for various medical device classes, Morulaa ensures your product meets all necessary requirements efficiently, making it well-positioned for success in the India medical device market for European, US, UK, Japanese, Korean, Asian, and other global manufacturers. Medical device revision applications with the CDSCO on the SUGAM portal via MD14 Application apply to all classes of devices—Class A, B, C, and D—and include sectors such as Dermatology, Aesthetic, Wearable Devices, Pediatrics, and Rehabilitation. This process ensures compliance with regulatory standards for medical devices in India.
2. Market Presence of Similar Products
Do similar medical devices already exist in the Indian market? If yes, you’ll need to assess what sets your device apart—whether it’s better quality, unique functionality, or competitive pricing.If no comparable products are available, manufacturers need to prepared to invest in local clinical trials for medical devices in India to demonstrate the safety and efficacy of their product in the local population. Morulaa HealthTech can guide manufacturers in the local requirements needed for clinical trials if required.
3. Pricing Strategy for Medical Devices in India
India is a highly price-sensitive market, where the affordability of medical devices often determines their success. Conducting a cost analysis of your product versus competitors becomes important.
Morulaa HealthTech supports manufacturers in pricing strategy development for the Indian market, helping manufacturers to ensure that their device is competitively priced while maintaining profitability. Our market research services provide insights to help you position your product effectively, including Market analysis for hospital equipment and medical devices such as surgical equipment in Orthopedic, Cardiology, etc to ensure informed decision-making.
4. Building a Long-Term Presence in India
Establishing a foothold in the Indian medical device market requires patience, dedication, and significant investment of time and resources. A short-term approach will not yield results. Manufacturers must be willing to invest 2-3 years in building relationships, establishing a distribution network, and gaining trust in the market.
With an extensive network of over 125 business houses, Morulaa HealthTech supports in finding distributors for medical devices in India. Our distributor search services help you connect with reliable partners who are in alignment with your business goals. Additionally, Morulaa provides ongoing support for the Indian medical device market, offering specialized services for European, US, UK, Japanese, Korean, Asian, and other global manufacturers – purchase order management, marketing support, etc even after an agreement is signed for continued business in India.
Why Partner with Morulaa HealthTech?
Hence, targeting India has its own sets of unique challenges while it has huge opportunities. It also requires an understanding of the regulatory documentation. The Patience in compiling detailed files which is typically not asked in many other Asian markets and building personal relationship and rapport with distributors and sales people where you are used to working over Email over here, WhatsApp face-to-face meetings, and phone calls, go along way and developing business Morulaa HealthTech, a trusted name among medical device consultants in India, offers end-to-end solutions—from regulatory compliance and market research to distributor search and pricing strategies. We also specialize in In Vitro Diagnostics (IVD) registration, ensuring that you meet all regulatory requirements for your product category.
If you’re considering India as your next market, reach out to Morulaa HealthTech for expert support tailored to your business needs.