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What is the (MDR) Medical Device Rule 2017 in India?

In India, medical devices are regulated by CDSCO (Central Drug Standard Control Organisation), and it has two licensing authorities. The CLA and the SLA. The CLA (Central Licensing Authority) is responsible for all the class C and class D medical device manufacturing, loan and wholesale licenses, and import device licensing in India. On the other hand, the SLA (State Licensing Authority) is responsible for Class A and Class B medical device manufacturing in India and loan and wholesale licenses. As you scroll downward, you will be able to find different types of medical devices in India along with their approval process.

Medical devices that are imported from outside of India, that follow international regulations and have already received approval from other countries like- the European Union (EU), the U.S , Japan, Canada, Australia, etc., can apply for their their regulated medical devices to be legally sold in India. As per the Medical Device Rule- The medical devices have to go through clinical investigations and have to provide an appropriate intended use for the investigational clinical studies in India.

Medical Device Approval in India

The expansion in commercialisation of bio-science technology has led to a boosted ecosystem in the healthcare industry. The medical device manufacture for sale market in India is expected to grow up to 5 billion dollars by 2025. Corpbiz has been a pioneer in the Indian medical device registration and approval process for years. Our consultants are behind some of the most innovative and essential medical device approvals in India by helping them cope with all the intricacies and compliance of the approval process. Corpbiz has a team of 50+ medical device registration consultants in India. Gone are the days when there were no rules and regulations related to medical devices in India. Today, India not only has an advanced medical regulatory system but also has proper guidelines and Acts that have been passed to help uplift this emerging industry.

Medical Device Classification in India

In India, medical devices are classified into five essential segments-

  • Diagnostic Imaging- X-rays, MRI, Ultrasound, etc.
  • Consumables and Disposables- Syringes, needles, etc.
  • Dental Devices and Products: Braces, dentures, etc.
  • Prosthetic and Orthopedic Devices- artificial joints, knee implants, etc.
  • Patient Aids- Pacemakers, Hearing Aids, etc.

All the above-mentioned device categories require registration from CDSCO. SLA or CLA may be approached for the same.

Services for Medical Device Registration and Approval

Services can be availed by both manufacturers and importers for registration in India and are mentioned below-

Services for Manufacturers of Medical Devices

Various rules and regulations have been put in place by the government in the context of manufacturing medical devices in India. Classification of these medical devices determines the licensing authority that regulates them. Corpbiz provides medical device approval services for both classes A, B, and Class C and D medical devices.

Class A&B Medical Device Approval Services

  • License application advisory- Our experts will provide advisory support in the process of applying for the license to manufacture these devices.
  • Compliance- Our team will make sure that the device adheres to all the regulations and the manufacturing has been done compliantly.
  • Application filing- Our team will make sure that the application form has been filled out without any errors.
  • Necessary Paper Collection- Our team will assist you in assembling and gathering all the necessary necessary papers, affidavits, etc., required for the process.
  • End-to-End Support- Throughout the entire process, our experts will make sure that all your needs and queries are attended to by us.

Class C&D Medical Devices Approval Services

  • License application advisory- Our experts will provide advisory support in the process of applying for the license to manufacture these devices. Form MD 7 is to be filled for this process.
  • Compliance- Our team will make sure that the device adheres to all the regulations and the manufacturing has been done compliantly.
  • Application filing- Our team will make sure that the application form has been filled out without any errors. Form MD 9 is to be filled out for this process.
  • Necessary Paper Collection- Our team will assist you in assembling and gathering all the necessary necessary papers, affidavits, etc., required for the process.
  • End-to-End Support- Throughout the entire process, our experts will make sure that all your needs and queries are attended to by us.

Services for Foreign Manufacturers & Importers of Medical Devices

With this fast-paced and boosting Indian economy, international firms are now trying to enter the Indian medical device market. To regularise this aspect, the Indian government has revised the laws governing the import of these devices and made them friendlier towards importation. The process has been further simplified, but that does not mean it is not complex in terms of scrutiny from the regulators. The list of services offered by Corpbiz are-

  • Classification of the Medical Device- Our experts will help classify your medical equipment as per the Indian classification system.
  • Authorised Agent Support- As per the new regulations, a new medical device can enter the Indian market only with the help of an Authorised agent or registration Holder. Corpbiz is fully equipped to provide support in this step.
  • Import License- Form MD-14 is used to obtain an import license. Corpbiz will file the application on behalf of the importer.
  • Test License- To obtain a test license form, MD-16 has to be filed. Corpbiz will file the application on the behalf of the importer.
  • End-to-End Support- Our experts will offer their services and support from the initial days to the final days of the registration.

Services for New Innovations in the Medical Devices Industry

When a new medical device arrives with features that aren’t present in other alternatives available in the market, then appropriate tests have to be conducted to make sure that the device is safe to be distributed in the market. The services offered by us are-

For Importers

  • Application to conduct an investigation- Corpbiz will file the application to conduct the investigation of the new device; only the devices that fall in the category C & D are subjected to this investigation. For this, Form MD-23 has to be filed.

  • Application for test license- Companies who wish to import new devices to India will have to first get a test license. The test license can be availed by filing Form MD-17 and MD-16. Corpbiz will file the application on your behalf.

  • Application to import a new medical device- Corpbiz will file the form MD-22 on your behalf to aid you in importing a new medical to India.

For Manufacturers

  • Application to conduct a medical investigation- Corpbiz will file the application to conduct the investigation of the new device; only the devices that fall in the category C & D are subjected to this investigation. For this, Form MD-23 has to be filed.
  • Application for test license- Corpbiz will assist the manufacturers in filing the application to obtain a test license. For this, Form MD-12 and Form MD-13 have to be filed in order to avail the license.
  • Application to manufacture new medical device- Corp will file Form MD-26 on your behalf to manufacture a new medical device in India.

What are Notified Medical Devices?

Notified devices are the type of list of devices that are regulated under the Medical Device Rule (MDR), 2017. Notified devices in India refer to the requirements or gadgets specified by government authorities for mandatory registration compliance with safety standards.

Choose Corpbiz for India Medical Device Registration and Regulatory Approval Process

Corpbiz has a big network of associates and offices in Pan India and is fully equipped to provide support to the importers and manufacturers of Medical Devices. We will fill out all the applications and forms on your behalf with the respective state FDA authority. Our team will provide end-to-end support in filing, submitting, and obtaining required necessary papers for medical device approval in India. Our team of experts works diligently, and the services they offer are professional and proficient.

Medical device approval and Registration Process

The steps for medical device approval and compliance are listed below-

Studying the Regulatory Status

The DCGI, or the drugs controller general of India, is responsible for overseeing the medical devices and IVDs. It is a part of the Ministry of Health and Family Welfare's Central Drugs Standard Control Organisation (CDSCO). It is important to read and consider all the important notifications as well as amendments before determining the final regulatory status of the device. Experts at Corpbiz will conduct thorough research to determine this aspect.

Authorized Representative

In this step, the importer or the manufacturer will have to choose an authorised representative to follow the processes in accordance with CDSCO on their behalf. The power of attorney and wholesale license will be given to this representative. Corpbiz will provide appropriate assistance in this step. We are connected with many wholesale distributors in Pan India.

Testing the Device

Now, the device has to go through a thorough testing phase; the instruments falling in the category C & D are to be tested by a recognised facility or the National Institute of Biological Sciences (NIB). Corpbiz will provide advisory for the same.

Compilation of Application

The applicants must submit the application for medical device registration. After testing the device, the application forms for the same have to be compiled. The form will have to include all the details related to the manufacturing and technical specifications of the device. Corpbiz will provide end-to-end support for the same.

Import License Submission

After filing the form, the license of import or registration has to be availed from the CDSCO. To do that, a form has to be filed, and an association fee has to be paid. Corpbiz will fill out the form on your behalf.

Technical Presentation

Almost 25% of medical devices are called for a technical presentation in a face-to-face manner. A new device will also be reviewed by a subject expert committee. On successful demonstration, the device will be cleared. Corpbiz will help in making an appropriate necessary paper for the same.

Import License

The CDSCO issued the import license instead of a registration certificate. Form MD-15 has to be filled out in order to receive an Import license in India for medical devices.

Compliance to Register Medical Devices in India

The compliance related to registering a medical device is stated by the CDSCO. The guidelines issued by them are listed below-

  • No animals were harmed in the process.
  • No heavy metals were used in the device or cosmetics
  • No toxins were used in the manufacturing
  • Only the devices that have received approval from CDSCO are to be imported.

Compliance with ISO- 13585 for Medical Devices

A certified importer or manufacturer of a medical device must always adhere to the requirements of ISO 13485. Established quality management systems must undergo required changes with periodic independent audits. The changes must also be made as per ISO 13485.

Benefits of Medical Device Regulatory and Approval Process

There are many benefits of the medical device approval and registration process in India. Some of the major benefits are listed below-

  • Compliance with medical device regulations makes sure the device is safe to use, hence ensuring that the machine is there to benefit the patients.
  • The process also aids in a smooth auditing process for medical devices in India.
  • The process also leads to regulating the prices of these medical devices.
  • Patients will be offered compensation if they're injured or harmed because of these medical devices.
  • Uniformity in the standards allows quality standards to be maintained throughout the export as well as import process.
  • The process helps keep non-compliant, low-grade products out of the market.
  • It boosts the domestic production of these devices.

Need for Medical Device Approval and Compliance

The Indian healthcare industry has rapidly become one of the biggest industries in the country. With a market worth $200 Billion as of 2023, it has been forecasted that it will grow to $370 billion by 2025. The Indian government has made efforts over the years to renew the focus as well as cater to the rising demand for medical devices and goods in India. Today, India has more than 900+ manufacturers of pharmaceutical equipment and products, comprising the fact that India currently is the 4th largest manufacturer of pharmaceuticals. The operations and workings of this industry are regulated by the Central Drug Standard Control Organisation (CDSCO), which comes under the Drug Controller General of India. Previously, only 15 categories of these medical devices were covered and subjected to Indian clearance procedures. While the rest of the market stayed unregulated, the majority of the market’s income was captured by global med-tech companies. With the introduction of uniform standards, the medical equipment available in India is on par with global standards.

Challenges in the Medical Device Approval Process and Compliance

Just like any other industry, the import and export of medical devices and the approval process come with its own challenges. Medical device manufacturers, too, face many challenges in areas like the supply of raw materials, operations, and testing. Here are some of the major challenges in the medical device approval process and compliance-

Vendor Management

It is not always easy to find a reliable vendor who delivers quality goods. The parts used in these medical devices have to qualify for a certain set of criteria and quality standards. Hence, maintaining the quality is the biggest issue when it comes to vendor and vendor management.

Quality Control

Stringent quality standards are to be maintained by taking adequate and effective quality control measures to ensure all the components are working as they should. It is important to monitor this process, and many companies struggle in this area.

Regulatory Compliance

As we already know, medical device approval requirements in India are large and heavily regulated. When it comes to family welfare, to ensure safety and effectiveness, the regulations and compliance for Medical devices in India are long and tedious.

Strict Safety And Efficacy Standards

medical devices must meet strict safety and efficacy standards to gain approval in India. Ensuring that a device complies with these standards requires extensive testing and paper works, often extending the time and resources needed for approval.

Clinical Trial and Execution

The design and execution of clinical trials represent a critical phase in the approval process. Designing studies that generate robust and meaningful data, recruiting suitable patient populations, and effectively managing trials are formidable challenges.

Data Collection and Analysis

Accurate data collection and analysis are paramount for demonstrating a device's safety and efficacy. Challenges may arise in obtaining comprehensive data, especially for long-term outcomes.

Resource Intensive Process

The medical device approval process demands substantial resources, including financial investments, personnel, and time. Small or emerging companies may face particular difficulties in navigating these resource-intensive requirements.

What are the Advantages of hiring a service provider for Medical Device Approval and compliance?

There are many advantages of hiring a service provider like Corpbiz for intricate and heavily regulated processes like medical device approval and compliance. Some of the advantages are listed below-

Fast Approval Process

Working with an experienced consultant can significantly speed up the process of getting approval for your medical device. These consultants have extensive knowledge and expertise in navigating the various regulatory requirements, developing strategies, attending meetings, submitting applications, and more. Testing is crucial to ensure that your device meets regulatory standards. A seasoned consultant can provide access to advanced technology-enabled tools that can streamline the testing process, ultimately leading to faster approval.

Domain Expertise

Consultants bring valuable prior experience and knowledge to your team, enabling you to overcome obstacles quickly without lengthy learning curves. They come equipped with all the necessary tools to help you meet compliance requirements in less time while reducing risk and costs. These professionals are well-versed in identifying potential slowdowns and mistakes in your processes, allowing you to address them before they cause any significant issues.

Awareness and Current Knowledge

Our consultants always make sure that they stay up to date with the latest FDI and ISI regulations in India. They are well-versed in the processes, and they always make sure that they are updated with the latest tech, tools, compliance guidelines, etc., available in the market. Connect with our consultants today to make sure you don't stay behind in this med-tech revolution.

Frequently Asked Questions (FAQs)

In India, the CDSCO regulates and approves medical devices to enter the Indian Medical Device Market.

CDSCO is the FDA Equivalent in India for medical devices.

The Medical Devices Policy in India aims to streamline the regulations, incentivise the manufacturing industry, and increase the efficiency of R&D for medical devices.

A licence for manufacturing facilities to sell, export, and import Medical devices has to be obtained from the Central Drugs Standard Control Organisation in India.

Yes, compliance with ISO 13485 is mandatory in India for Medical device approval and registration.

To get your hands on the CDSCO, you have to follow the step-by-step process of medical device approval in India. The steps include-

  • Submitting ID Proof
  • Submission of Undertaking
  • A hard copy of the Address Proof
  • Filing of the Application form

In India, the Drug and Cosmetic Act regulates the manufacturing, import, and distribution of drugs.

A Clinical assessment or investigation in India means testing to check the safety and performance of the medical devices for sale or for distribution in the Indian Market.

The conformity assessment is testing the technical specification as well as the design of the medical devices as per the guidelines.

The function of the Health and Family Welfare Ministry is to implement various health and family welfare related programmes on a national level in India. They conduct the Materiovigilance programme of India as well.

As per officials, there are about 21 authorised medical devices in India.

The demand for medical devices in India is a $5 Billion market, and the demand in India must increase in the future as well.

The medical devices imported into India are-

  • Ultrasonic Scans
  • PCR (Polymerase Chain Reaction) Test Tech.
  • Medical Imaging
  • Cancer Diagnostics, etc.

Since January 2018, the CDSCO has been the force control on medical devices in India.

Some of the examples of medical devices in India are-

  • Spinal needles
  • dental Implants
  • Catheters
  • Cardiac Stents, etc.

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