A Beginner’s Guide to Regulatory Approval for Indian MedTech Startups

Part 1 — Writing a Compelling Cover Letter for MD12 Application

Photo by Piron Guillaume on Unsplash

Many innovators excel in the technical aspects of creating medical devices. However, navigating the complex regulatory path to commercialization can be daunting. This blog cuts through the confusion and equips innovators & startup founders with the essential first step: obtaining a Test License to Manufacture a Medical Device. This license, granted by the Central Drugs Standard Control Organisation (CDSCO) through an MD12 application, is crucial for responsible development.

For medical device manufacturers, securing a test license before the actual manufacturing license prioritizes patient safety. It ensures a controlled environment for initial exploration, minimizing potential risks during later clinical trials or widespread use. Regulatory bodies require this license to verify preliminary safety assessments before broader approval.
Furthermore, a test license facilitates the collection of valuable data on the device’s performance and potential side effects. This data plays a critical role in refining the device before larger trials, allowing for significant improvements.

Additionally, obtaining a test license demonstrates adherence to established regulatory frameworks, streamlining the path to future commercialization approvals. This compliance builds trust with regulatory bodies and accelerates the process.

Finally, testing under a test license promotes cost-effectiveness. By enabling early identification of potential issues, it saves resources compared to encountering problems during larger trials.

In essence, a test license fosters a responsible development process, building investor confidence and paving the way for a safe and successful medical device. By taking this crucial first step, innovators can ensure their groundbreaking creations reach patients effectively, while also providing safe and controlled environments for training healthcare professionals on their proper use.

The CDSCO requires a comprehensive set of documents for licensing. This guide delves into the details of regulatory submissions:

Step 1: Classify Your Innovation based on Indian Medical Device Classification System

The classification system plays a crucial role in determining the regulatory pathway a medical device needs to follow for market approval in India. Lower-risk devices generally require less stringent regulatory requirements compared to higher-risk devices. This includes the type of documentation needed, testing procedures, and the length of the approval process.

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India based on their potential risk to patients. This risk-based approach categorizes devices into four classes:

• Class A: Low-Risk Devices: These are the simplest medical devices with minimal potential for harm. Examples: Urinary Drainage Unit, Pharynscope
• Class B: Moderate-Risk Devices: These devices are more complex than Class A and may cause moderate harm if they malfunction. Examples: Angioscope, Aspiration Needle and Syringe
• Class C: High-Risk Devices: These devices can cause serious injuries or even death if they malfunction. They require more stringent regulatory controls compared to Class A and B devices. Examples: Vein Ablation Device, Injector Type actuator syringe
• Class D: Highest-Risk Devices: These are the most complex devices with the highest potential for causing serious harm or supporting critical life functions. They undergo the most rigorous regulatory review before being granted market authorization. Examples: Cardiovascular Catheter, Occlusion Catheter

A thorough understanding of India’s medical device classification system empowers manufacturers to develop streamlined regulatory strategies and accelerate the time it takes to bring their life-saving technologies to market. To achieve efficient regulatory navigation, accurately classify your device within the established risk categories (Class A, B, C, or D) based on its potential risk profile.

The No.DCG (I/Misc./2017 (68) document dated June 29th, 2017 offers a reference point for similar device categories and additional relevant information to aid in classification under the section “LIST OF MEDICAL DEVICES ALONG WITH THEIR RISK CLASS”.

Additional Considerations

• The classification of a medical device can sometimes be subjective and may require clarification from the CDSCO.
• Manufacturers should consult with regulatory experts to ensure their devices are classified correctly to avoid delays in the approval process.

This DCG Notice is not an exhaustive list of all medical devices within each class. New and innovative devices may require a risk assessment by the CDSCO to determine their appropriate classification.

Step 2: Checklist for MD12

Submitting an application for a test license requires specific documents. CDSCO website provides a comprehensive checklist outlining all the necessary documents. To access the checklist, simply search for “MD12” as the form and “MD” as the category. You can then download the checklist, which details the essential documents required for your license application. This blog dives into key practices for writing a standout cover letter, including both good starting points and best practices for maximizing the impact of your medical device company and device.

Mastering the Covering Letter — Making a Stellar First Impression

The initial checklist item requested by the CDSCO for your test license application is a cover letter. This document is an opportunity to make a positive first impression on the reviewing body. As the very first document they encounter, a well-written and informative cover letter is instrumental in securing a successful application. Here are the key elements that will contribute to a winning cover letter:

1. Draft a Compelling Introduction:

A captivating introduction sets the stage for your entire application and grabs the reviewer’s attention. Here’s what you can present in this section:

• Start with a brief: Briefly introduce your company’s mission and its focus on developing innovative medical technology solutions. Highlight your planned location of manufacturing.
• Showcase your passion: Express your enthusiasm for developing this groundbreaking device and its potential to improve patient care.

Example: “We XYZ (company name), a leading medical technology innovator dedicated to developing angioscopes and related accessories that revolutionize patient care. We are driven by a relentless pursuit of innovation, translating groundbreaking ideas into tangible solutions that address unmet medical needs. We are based out of ABC (address)”

2. Outline Your Medical Device:

• Technical Specifications: Firstly, outlining your device’s technical specifications and functionalities demonstrates your company’s deep understanding of the technology. This expertise instills confidence in the CDSCO as they evaluate your application.
• Patient Benefits: Secondly, by clearly articulating the intended use and potential patient benefits, you directly address the CDSCO’s focus on patient safety and well-being. Highlighting how your device addresses unmet medical needs or improves existing treatments showcases your alignment with regulatory goals. Furthermore, explaining these benefits justifies the need for testing, strengthening your case for obtaining a test license.
• Impact Quantification (Optional): Finally, including quantifiable data like preliminary study results or projected improvements in healthcare outcomes (if available) strengthens your claims and adds credibility to your application. This data-driven approach provides the CDSCO with a clearer picture of the device’s potential impact, ultimately increasing your chances of a successful test license application. Here’s what you can present in this section.

Example: “Our innovative product, XYZ Angioscopes, falls under the Class B device classification, allowing for visual examination of blood vessel interiors. These ultrathin, flexible angioscopes boast high-resolution miniature cameras at their tips. Inserted through a minute incision, they grant doctors direct visualization of the vasculature. This minimally invasive procedure offers substantial advantages. By providing a clear view, angioscopy facilitates the diagnosis of blockages, abnormalities, and vascular damage. This leads to more accurate diagnoses and optimized treatment plans. Furthermore, our angioscopes can be used to guide procedures like angioplasty and stent placement, enhancing their effectiveness.”

3. State Your Purpose Clearly:

A clear and concise statement outlining your purpose in the cover letter is critical for a successful test license application. This demonstrates two key aspects: professionalism and understanding of the process. Stating your request for a Test License (MD12) showcases your preparedness and familiarity with the regulatory pathway.

• Specify the intended use of the license: Secondly, specifying the intended use, whether for clinical investigations, internal testing, or training, ensures your application aligns with the appropriate regulations. This clarity helps the CDSCO reviewers assess your application efficiently and within the correct context. Ultimately, a well-defined purpose statement avoids delays in approvals.

Example: “In conjunction with the commencement of the manufacturing process for our innovative medical device, Everlast, we formally request a Test License to Manufacture. This license, obtained through Form MD12, would enable us to produce a limited quantity of ten (10) devices for the express purpose of conducting essential technical studies and pilot clinical trials. We have attached all relevant supporting documentation to this letter for your review.”

4. Finish with an Effective Closing Remarks:

The closing section of your cover letter for a Test License application serves several important purposes:

• Professional Courtesy and Respect: Expressing gratitude for the CDSCO’s time and consideration demonstrates professionalism and respect for their role. It sets a positive tone and establishes a foundation for a collaborative review process.
• Completeness and Transparency: Mentioning that you’ve attached all required documents as per the MD12 checklist assures the CDSCO that your application is complete and fulfills all regulatory requirements. Highlighting your commitment to transparency fosters trust and confidence in your application.
• Review Request and Open Communication: By politely requesting the CDSCO’s review, you encourage them to begin the evaluation process. Additionally, offering your willingness to provide further information or clarify any aspects of your application reinforces your commitment to transparency and demonstrates a proactive approach. This can help streamline the review process by addressing any potential questions or concerns upfront.

A well-crafted closing section fosters professionalism, ensures application completeness, and promotes open communication. This fosters a positive working relationship with the CDSCO and increases the chances of a smooth and successful review process for your Test License application.

Example: “We thank the CDSCO for considering our Test License application for Everlast. We’ve attached all required documents (MD12 checklist) and are committed to transparency. Should any clarification be needed, please don’t hesitate to contact us. A prompt license issuance would expedite Everlast’s development, allowing internal and third-party validations. Everlast has the potential to significantly improve patient care, and we’re eager to collaborate with the CDSCO to bring this innovation to life.”

5. Other Etiquettes:

Maintain a clear and professional tone throughout your cover letter. Proofread meticulously to eliminate any grammatical errors or typos. Utilizing your company letterhead adds a polished touch. Tailor your cover letter to the specific medical device you are developing. This demonstrates a deep understanding of your product and its potential impact on the healthcare landscape.

By following these guidelines, you can craft a compelling cover letter that effectively communicates your company’s dedication to patient safety and innovation, and the promising potential of your medical device. This will undoubtedly strengthen your application and increase your chances of securing a Test License.

Bonus: A Template to Get You Started — MD12- Coverletter Template

To wrap things up, the following blogs in this series will unpack the key strategies for building standout documentation that complements the rest of your checklist items.

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