Report Overview

India Medical Device Testing and Certification Market – Industry Trends & Forecast Report - 2029

India medical device testing and certification market size was estimated at USD 1,674.9 million in 2022. During the forecast period between 2023 and 2029, the India medical device testing and certification market size is projected to grow at a CAGR of 5.2% reaching a value of USD 2,388.4 million by 2029. Increasingly stringent government requirements, an increase in the number of small medical device companies without in-house expertise, and rising demand for medical device verification and validation are some of the market-driving drivers.

India Medical Device Testing and Certification Market – Overview

Medical device testing and certification are crucial processes that ensure the safety, efficacy, and regulatory compliance of medical devices before they are allowed to be marketed and used by healthcare professionals and patients. These processes are vital to guarantee that medical devices meet the required quality and performance standards and do not pose unnecessary risks to patients or users.

India Medical Device Testing and Certification Market

Growth Drivers

Increasingly High Needs for Medical Devices in India

India's healthcare infrastructure is expanding to cater to the needs of a growing population. This includes the establishment of hospitals, clinics, and medical facilities across the country. The increased use of medical devices in these facilities necessitates rigorous testing and certification. Lifestyle-related diseases such as diabetes, cardiovascular diseases, and respiratory disorders are on the rise in India. These conditions often require the use of medical devices for diagnosis, treatment, and monitoring. India's elderly population is growing, leading to a higher demand for medical devices such as pacemakers, joint implants, and home healthcare equipment. Ensuring the safety and efficacy of these devices is essential.

Restraints

High Testing and Certification Costs

Small and medium-sized manufacturers of medical devices may find it financially challenging to bear the high costs associated with testing and certification. This can deter them from entering the market or developing innovative devices. High certification costs can restrict access to cutting-edge medical device technologies and innovations. This limitation can hinder the introduction of advanced healthcare solutions in India. The expenses incurred for testing and certification are often passed on to consumers in the form of higher product prices. This can make medical devices less affordable for patients and healthcare facilities.

Impact of COVID-19 on India Medical Device Testing and Certification Market

The pandemic created a surge in demand for medical devices, such as ventilators, diagnostic equipment, personal protective equipment (PPE), and other medical equipment. This increased demand necessitated swift testing and certification to ensure product quality and safety. To address the urgent healthcare needs during the pandemic, regulatory authorities in India, such as the Central Drugs Standard Control Organization (CDSCO), expedited the approval and certification processes for critical medical devices, including COVID-19 diagnostic kits and ventilators. Disruptions in the global supply chain due to lockdowns and transportation restrictions led to a shortage of certain medical devices. This increased the demand for domestic manufacturing and the need for prompt certification.

India Medical Device Testing and Certification Market

Segmental Coverage

India Medical Device Testing and Certification Market – By Service Type

Based on service type, the India medical device testing and certification market is divided into Testing Services, Inspection Service, and Certification Services segments. The testing services segment holds the largest share by service type. Patients and healthcare providers in India are increasingly aware of the importance of using certified and safe medical devices. This awareness drives the demand for thorough testing and certification. Some medical device manufacturers are establishing in-house testing facilities to streamline the certification process and reduce time-to-market. These facilities may require third-party testing services for validation.

India Medical Device Testing and Certification Market – By Sourcing Type

Based on sourcing type, the India medical device testing and certification market is split into In-House and Outsourced segments. The in-house segment is expected to grow at a higher CAGR over the forecast period. In-house facilities allow manufacturers to have more control over the testing and certification process. This control can lead to faster turnaround times, which are crucial in getting products to market quickly. Over time, having an in-house facility can lead to cost savings, as manufacturers will not need to rely as heavily on external testing and certification services, which can be expensive.

India Medical Device Testing and Certification Market – By Device Class

Based on device class, the class 1 segment is expected to grow during the forecast period. The healthcare industry in India is growing, along with the facilities and infrastructure that support it. An increasing demand for a variety of medical devices, particularly Class 1 devices, is a result of this expansion. Simple bandages for portable surgical instruments are all considered to be class 1 products. The market for these devices is driven by the variety of healthcare applications and needs. Despite being low-risk, Class 1 devices must still adhere to regulatory compliance requirements established by organizations like the Central Drugs Standard Control Organisation (CDSCO). A certification is required to prove conformity.

India Medical Device Testing and Certification Market – By Technology

By technology, the India medical device testing and certification market is divided into active implant medical device, active medical device, non-active medical device, in vitro diagnostic medical device, ophthalmic medical device, orthopedic & dental medical device, and other segments. The active implant medical device is expected to grow in the forecast period. The prevalence of chronic diseases, such as cardiac conditions, neurological disorders, and diabetes is on the rise in India. AIMDs like pacemakers, neurostimulators, and insulin pumps are crucial for managing these conditions, driving demand. India's aging population is more susceptible to age-related diseases and conditions that require implantable medical devices. This demographic trend is contributing to the growth of AIMDs. Advances in medical device technology have led to the development of more advanced and sophisticated AIMDs. These devices often require specialized testing and certification.

India Medical Device Testing and Certification Market – By Region

Based on region, the India medical device testing and certification market is divided into North India, South India, East India, and West India. North India is expected to grow during the forecast period. The region has witnessed substantial growth in healthcare infrastructure, including hospitals, clinics, and medical facilities. This expansion has led to increased demand for a wide range of medical devices that require testing and certification. Some states in North India, like Haryana and Punjab, have become prominent manufacturing hubs for medical devices. The presence of manufacturing facilities has naturally led to a higher demand for testing and certification services to ensure product quality and compliance.

Competitive Landscape

Major players operating in India medical device testing and certification market include SRL Limited, Bureau Veritas India, SGS India Private Limited, Intertek India Private Limited, UL India Private Limited, Asia Quality Focus, Micom Laboratories India Pvt Ltd, Toxikon India Pvt Ltd, Cliniminds, and RMS Healthcare. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

Recent Developments

• In January 2022 - To increase the scope of its assurance programmes for medical devices, DNV, a leading provider of certification, assurance, and risk management, acquired MEDCERT.

Scope of the Report

By Service Type

• Testing Services

• Inspection Service

• Certification Services

By Sourcing Type

• In-House

• Outsourced

By Device Class

• Class I

• Class II

• Class III

By Technology

• Active Implant Medical Device

• Active Medical Device

• Non-active Medical Device

• In Vitro Diagnostic Medical Device

• Ophthalmic Medical Device

• Orthopedic & Dental Medical Device

• Others

By Region

• North India

• South India

• East India

• West India

1. Research Framework
   1. Research Objective
   2. Product Overview
   3. Market Segmentation
2. Executive Summary
3. India Medical Device Testing and Certification Market Insights
   1. Industry Value Chain Analysis
   2. DROC Analysis
      1. Growth Drivers
         1. Rising healthcare needs due to a growing population and increasing lifestyle-related diseases
         2. Stringent regulations and compliance standards set by government bodies
         3. Rapid technological advancements and innovations in medical device manufacturing
      2. Restraints
         1. High testing and certification costs
         2. Complex and evolving regulatory frameworks
      3. Opportunities
         1. Government initiatives promoting domestic manufacturing and supporting medical device companies
         2. Collaboration between testing laboratories, manufacturers, and research institutions
      4. Challenges
         1. Risks associated with intellectual property theft or infringement during the testing and certification process
   3. Technological Advancements/Recent Developments
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of New Entrants
      4. Threat of Substitutes
      5. Intensity of Rivalry
4. India Medical Device Testing and Certification Market Overview
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Service Type
         1. Testing Services
         2. Inspection Service
         3. Certification Services
      2. By Sourcing Type
         1. In-House
         2. Outsourced
      3. By Device Class
         1. Class I
         2. Class II
         3. Class III
      4. By Technology
         1. Active Implant Medical Device
         2. Active Medical Device
         3. Non-active Medical Device
         4. In Vitro Diagnostic Medical Device
         5. Ophthalmic Medical Device
         6. Orthopedic and Dental Medical Device
         7. Others
      5. By Region
         1. North India
         2. South India
         3. East India
         4. West India
5. North India Medical Device Testing and Certification Market
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Service Type
      2. By Sourcing Type
      3. By Device Class
      4. By Technology
6. South India Medical Device Testing and Certification Market
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Service Type
      2. By Sourcing Type
      3. By Device Class
      4. By Technology
7. East India Medical Device Testing and Certification Market
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Service Type
      2. By Sourcing Type
      3. By Device Class
      4. By Technology
8. West India Medical Device Testing and Certification Market
   1. Market Size & Forecast, 2019–2029
      1. By Value (USD Million)
   2. Market Share & Forecast
      1. By Service Type
      2. By Sourcing Type
      3. By Device Class
      4. By Technology
9. Competitive Landscape
   1. List of Key Players and Their Offerings
   2. India Medical Device Testing and Certification Company Market Share Analysis, 2022
   3. Competitive Benchmarking, By Operating Parameters
   4. Key Strategic Developments (Mergers, Acquisitions, Partnerships, etc.)
10. Impact of Covid-19 on India Medical Device Testing and Certification Market
11. Company Profile (Company Overview, Financial Matrix, Competitive Landscape, Key Personnel, Key Competitors, Contact Address, Strategic Outlook, SWOT Analysis)
    1. SRL Limited
    2. Bureau Veritas India
    3. SGS India Private Limited
    4. Intertek India Private Limited
    5. UL India Private Limited
    6. Asia Quality Focus
    7. Micom Laboratories India Pvt Ltd
    8. Toxikon India Pvt Ltd
    9. Cliniminds
    10. RMS Healthcare
    11. Other Prominent Players
12. Key Strategic Recommendations
13. Research Methodology
    1. Qualitative Research
       1. Primary & Secondary Research
    2. Quantitative Research
    3.  Market Breakdown & Data Triangulation
       1.  Secondary Research
       2.  Primary Research
    4.  Breakdown of Primary Research Respondents, By Region
    5.  Assumptions & Limitations

*Financial information of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable.

List of Figures

Figure 1       India Medical Device Testing and Certification Segmentation

Figure 2       India Medical Device Testing and Certification Market Value Chain Analysis

Figure 3       Company Market Share Analysis, 2022

Figure 4       India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Figure 5       India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Figure 6       India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Figure 7       India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Figure 8       India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Figure 9       India Medical Device Testing and Certification Market Share, By Region, By Value, 2019–2029

Figure 10     North India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Figure 11     North India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Figure 12     North India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Figure 13     North India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Figure 14     North India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Figure 15     South India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Figure 16     South India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Figure 17     South India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Figure 18     South India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Figure 19     South India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Figure 20     East India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Figure 21     East India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Figure 22     East India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Figure 23     East India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Figure 24     East India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Figure 25     West India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Figure 26     West India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Figure 27     West India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Figure 28     West India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Figure 29     West India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

List of Tables

Table 1        India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Table 2        India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Table 3        India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Table 4        India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Table 5        India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Table 6        India Medical Device Testing and Certification Market Share, By Region, By Value, 2019–2029

Table 7        North India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Table 8        North India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Table 9        North India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Table 10      North India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Table 11      North India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Table 12      South India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Table 13      South India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Table 14      South India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Table 15      South India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Table 16      South India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Table 17      East India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Table 18      East India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Table 19      East India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Table 20      East India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Table 21      East India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Table 22      West India Medical Device Testing and Certification Market Size, By Value (USD Million), 2019–2029

Table 23      West India Medical Device Testing and Certification Market Share, By Service Type, By Value, 2019–2029

Table 24      West India Medical Device Testing and Certification Market Share, By Sourcing Type, By Value, 2019–2029

Table 25      West India Medical Device Testing and Certification Market Share, By Device Class, By Value, 2019–2029

Table 26      West India Medical Device Testing and Certification Market Share, By Technology, By Value, 2019–2029

Table 27      SRL Limited Company Overview

Table 28      SRL Limited Financial Overview

Table 29      Bureau Veritas India Company Overview

Table 30      Bureau Veritas India Financial Overview

Table 31      SGS India Private Limited Company Overview

Table 32      SGS India Private Limited Financial Overview

Table 33      Intertek India Private Limited Company Overview

Table 34      Intertek India Private Limited Financial Overview

Table 35      UL India Private Limited Company Overview

Table 36      UL India Private Limited Financial Overview

Table 37      Asia Quality Focus Company Overview

Table 38      Asia Quality Focus Financial Overview

Table 39      Micom Laboratories India Pvt Ltd Company Overview

Table 40      Micom Laboratories India Pvt Ltd Financial Overview

Table 41      Toxikon India Pvt Ltd Company Overview

Table 42      Toxikon India Pvt Ltd Financial Overview

Table 43      Cliniminds Company Overview

Table 44      Cliniminds Financial Overview

Table 45      RMS Healthcare Company Overview

Table 46      RMS Healthcare Financial Overview