Unleashing the Power of Medical Devices Repair Business in India

Are you ready to tap into India's booming healthcare industry by launching your medical devices repair business in India? 

Look no further - we've covered you with our comprehensive guide to successfully launching and growing medical devices repair business in India. But before doing so, Let us understand the scenario and status of the medical devices industry.

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According to the Ministry of Chemicals and Fertilizers, the medical devices sector in India is a sunrise sector that is growing at a fast pace. The market size of the medical devices sector in India is estimated to be $11 billion (approximately ₹ 90,000 Cr) in 2020, and its share in the global medical device market is estimated to be 1.5%.

The medical devices industry in India has proven to be essential in the healthcare sector, particularly during the COVID-19 pandemic. The production of medical devices, including diagnostic kits and Rapid Testing Anigen Test Kits, became increasingly popular and necessary during this time. Clearly, the sector's contribution to the healthcare industry in India is significant and continues to skyrocket for the entrepreneurs of this industry. However, navigating the complexities of the market and building a successful business can be challenging without the proper guidance. 

From conducting market research and identifying your target audience to creating a solid business plan and building strong relationships with suppliers, we will provide you with the insights and strategies you need to succeed.

What does Medical Devices Mean?

According to the most recent notification of the Medical Devices Amendment Rule 2021 in India, medical devices are defined as "Devices utilized in general medical practice, including medical apparatus, instruments, implants, appliances, etc. These devices can be used individually or in combination and are specifically designed for human beings or animals. Their purpose is to achieve the intended function as specified below, but they are not intended to fulfil the following requirements." 

The primary intended action on the human body or animals by any pharmacological immunological or metabolic means-  

• Analysis, prevention, observation, treatment, or mitigation of any disease or disorder;
• Analysis, observation, treatment, mitigation, or support for any injury or disability;
• Examination, replacement or alteration or support in findings of the anatomy or a physiological process;
• For supporting or sustaining life;
• Decontamination of medical devices; and
• Conception-related equipment & devices.

Salient Features of National Medical Devices Policy 2023

The National Medical Devices Policy of 2023 is a program designed to support the advancement of the medical device sector and address objectives such as access, innovation, and quality. By creating a manufacturing ecosystem that fosters innovation and establishes a strong framework for capacity-building programs, this sector of the economy can reach its full potential while meeting industry requirements and available resources. The policy aims to encourage domestic investments and the production of medical devices that align with the government's "Atmanirbhar Bharat" and "Make in India" initiatives.

As per the Ministry of Steel and Fertilisers, it accelerated its growth path with a patient-centric approach and emerged as the global leader in the manufacturing and innovation of medical devices by achieving a 10-12% share in the expanding global market over the next 25 years.  Policy is expected to help the Medical Devices Sector grow from the present $11 Bn to $50 Bn by 2030

Basic Requirements for Setting up Medical Devices Repair Business in India

The basic requirement for setting up a medical devices repair business in India consists of the following factors, which include-

• Manufacturing License 
• Import license
• Authorization of a person, under the D&C Act
• Warehouse license for distribution and storage
• IEC Code
• Factory License/ Registration 
• VAT & CST Registration
• Income Tax- PAN & TDS
• Shops & Establishment
• Professional Tax management 

Who Regulates the Medical Device Repair Business in India?

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the supervision of the Directorate General of Health Services.

India's medical device manufacturers or importers must register their products following the Drugs and Cosmetics Act of 1940. Failure to comply may lead to legal consequences, such as penalties and prosecution. The CDSCO and state drug control organizations have the authority to issue licenses for various types of drugs.

With the rise of health consciousness and the implementation of government health initiatives, it is expected that the Indian medical device market will continue to expand.

Step-by-Step Guide to Establishing Medical Devices Repair Business in India

It is acknowledged that a medical devices repair business in India might be a prospective venture, as it caters to the invincible demand for healthcare services along with the necessity to maintain medical equipment. But before you think of setting up a medical device repair business in India, you need to ensure and take care of the following factors, which revolve around the following-

• Step 1:- Conduct in-depth research and identify the market opportunities

Before aiming to establish any business venture, you need to undergo comprehensive market research to discover and identify the needs that come with it. Speaking of which, you should be able to gauge your competition, identify the market trends, and figure out the customer base. Without this, your business plan to establish a medical devices repair business in India would be incomplete.

Allow your research to assist you in having a detailed business plan while making informed decisions.

• Step 2:- Envision a detailed business plan 

Having a plan of action is crucial, which would shape your medical device business and pave the way for a lucrative venture. As per its ingredients, you may include the details based on the target market, offered pricing, marketing plans, and financial projections. The story does not end here, and you need to highlight the requirements, ranging from staffing requirements to paying heed to the needed permits or licenses.

• Step 3:- Obtain necessary permits and licenses

If a medical devices repair business in India lacks permits or licenses, it will be unsuccessful. Therefore, it is necessary to reach out to the local health department or regulatory authority to understand the necessary permissions on a broader scale. Maintaining compliance is essential to avoid doubts about trust or credibility with clients.

Ensure compliance with all applicable laws to maintain the credibility and trust of your clients.  

• Step 4:- Obtain funding for your medical devices repair business 

Before you begin with the medical devices repair business in India, you must create a detailed financial plan that would encourage you to seek funding options, including investors, personal savings or bank loans. In addition, you can estimate the capital requirements, revenue stream, and any startup costs as an idea to potential investors or lenders.

• Step 5:- Building strong relationships with suppliers

Maintaining professional contact with medical device manufacturers is a crucial marketing tactic that can significantly impact the success of your business. Take the time to sort through and identify suppliers who can offer you the equipment and spare parts you need at reasonable prices. Don't hesitate to take advantage of partnership opportunities that offer training and valuable information to help your business thrive.

Therefore, all these factors are necessary when setting up a medical device repair business in India.

Challenges faced by Medical Devices repair business 

The challenges faced by medical Devices Repair business in India are as follows- 

• Advisory for product quality

It is important to maintain the quality and safety of medical devices, such as pacemakers and coronary stents. This involves undergoing a thorough reliability process to ensure that the product is of high quality. It cannot be compromised with or left unattended. Failure to do so may not only damage the reputation of the brand but also raise serious concerns about the quality of the product in circulation. 

• Regulatory Compliance

Maintaining the quality of medical devices is essential for legal operation, manufacturing, or selling. This is a prerequisite for starting a medical device repair business, and following compliance regulations and obtaining licenses is crucial. It is necessary to adhere to these strict regulations and ensure the safety and effectiveness of the products.

In particular, medical devices repair business in India must comply with regulations and avoid any issues that could hinder their operations. To address this challenge, one must comprehensively understand the requirements within this jurisdiction. This knowledge will enable the establishment of robust quality management systems and facilitate the auditing process to ensure compliance. Therefore, staying updated on regulations and any changes is essential to avoid potential challenges.

• Rapid Technological Advancements

One of the potential hurdles to the medical devices repair business in India is maintaining the pace of rapid technological advancement. For instance, it is rapidly changing, and it becomes laborious for the technicians to adapt to them every now and then. 

To cater to this hurdle, you require investing in training and education for repair technicians to help them stay updated with the latest technology and techniques so they can better diagnose and fix any issue that might prevail with medical issues.

• Customer Expectations 

For medical devices repair business in India, it is evident how they must adhere to customer expectations and requirements. The individuals are primarily keen on repairing their media devices accurately and efficiently. 

To cater to this challenge of India's medical devices repair business in India, you must ensure effective communication and adhere to the deadlines and timelines. Accordingly, investing in quality control measures might ensure that the repairs are done wisely, accurately and in real-time.

Final thoughts: The Medical Devices Repair Business in India

Hence, establishing a medical devices repair business in India can be done smoothly provided you follow certain factors such as conducting thorough research, creating a detailed business plan, and acquiring the necessary permits and licenses. The COVID-19 pandemic has resulted in the growth of this business. Furthermore, the Government of India has implemented supportive policies that align with its objectives and continue influencing the medical devices industry today.