The medical device industry in India has witnessed very high growth in the past few years. As per the mentioned previous reports the size of the medical device industry has increased and it is estimated at ₹90,000 Crore (US $ 11 Billion) in 2022 it is expected to grow to US $50 Million billed by the end of 2030 with a CAGR of 16.4%.

So, if you are planning to manufacture medical devices in India?

This comprehensive guide will help you to navigate the licensing process. Through this, you can simply ensure that you meet the regulatory standards set by the CDSCO (Central Drugs Standards Control Organization). From understanding regulatory requirements to preparing essential documents, this step-by-step guide covers everything you need to know to get your medical device manufacturing license in India.

Glimpse Of Medical Device Industry For Manufacturer

Here are a few stats that show how the medical device industry is growing and making its own space in the market. Through this, you can simply figure out the scope of the medical device industry and how much regulatory compliance is important for the manufacturers.

• The size of the medical device market is estimated at ₹90,000 crore in 2022.
• US $50 Billion Expected growth by the year 2030.
• Indian medical device market share in the global market is estimated to be 1.65%.
• India is the 4th largest Asian medical device market after Japan, China, and South Korea.

Key Authorities Overseeing Medical Device Licensing

When you apply for the Medical Device Manufacturing License in India then you must understand the authorities that oversee medical device licensing services for the inspection and approval.

CDSCO (Central Drugs Standard Control Organisation)

The Central Drugs Standards Control Organization (CDSCO) is a national regulatory body. It is responsible for regulating medical devices and pharmaceuticals in India. It works under the Ministry of Health and Family Welfare. CDSCO plays a pivotal role in the approval of medical device manufacturing licenses.

Responsibilities Of CDSCO:

• CDSCO Regulates the production, sale, import, and distribution of medical devices.
• It ensures that manufacturers comply with guidelines, including ISO 13485 and Good manufacturing practices (GMP)
• Inspections of overseas manufacturing facilities.
• Issues and renews Medical Device Manufacturing License.

DCGI (Drug Controller General Of India)

The (DCGI) Drug Controller General Of India works under the CDSCO. It is the authority that is responsible for the approval and regulation of medical devices in India. The authority ensures that the medical devices adhere to safety and quality standards before they are manufactured, imported or distributed in the countries.

Role in Medical Device Licensing:

• Oversees the implementation of the Drugs and Cosmetics Act, of 1940 governed by medical devices.
• This will approve the high-risk medical devices licensing (Class C and Class D)
• Provide guidelines for clinical trials and testing of medical devices.
• The safety and efficacy of devices ensure Post Market Surveillance.

Drugs And Cosmetics Act Rules

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, govern the regulation of medical devices in India. The Act outlines the legal framework for ensuring that medical devices produced in India meet safety, efficacy, and quality standards.

Key Provisions:

• Share information about the regulatory requirements for medical device manufacturing.
• Specifies the role of CDSCO and DCGI in regulating medical devices.
• Classifies medical devices based on their risk factors (Class A to D).
• Mandates compliance with ISO 13485 and Good Manufacturing Practices (GMP).
• Enforces penalties for non-compliance and misconduct.

State Licensing Authority (SLA)

The State Licensing Authority (SLA) plays a vital role in regulating medical devices at the state level. While CDSCO manages the approval process for high-risk devices the other side SLA oversees the manufacturing of low-risk devices (Class A and Class B) within its respective state.

Responsibilities:

• This will issue the license for the manufacturing of low-risk medical devices (Class A & B)
• Conducts inspections and audits of manufacturing facilities.
• They will collaborate with CDSCO for the regulation of higher-risk (Class C & D)
• Ensure compliance with state-level rules and regulations.

What Is The Medical Device Classification According to The Risk Factor?

Risk factor classification plays a very crucial role in terms of medical devices. It helps in guaranteeing these devices’ efficiency and safety. In short, the risk posed by medical equipment to patients is considered while classifying them into various groups. Such As:

• Class A – Low Risk – Tongue depressors and bandages
• Class B – Low To Moderate Risk – Adhesives and Other Devices
• Class C – Moderate To High Risk – Pacemakers and implantable defibrillators
• Class D – High Risk – Heart Valve

Eligibility Criteria for Manufacturing License For Medical Devices

Before applying for the manufacturing license you must ensure that your facilities and business meet the CDSCO guidelines or criteria for eligibility. These include:

• Legal Entity – The applicant must be a legally registered entity such as a Private Limited, Company, LLP, or Public Limited Company.
• Facility Compliance – The manufacturing site should meet the standards for safety and quality control, as defined by CDSCO.
• Qualified Staff – Ensure you have a team of qualified technical and managerial staff to oversee operations and maintain product quality.

Documents Required For Manufacturing License For Medical Devices Registration

Here is the simplified list you have to attach to apply for a manufacturing license for medical devices look below as it is mentioned there:-

• TR6 Challan
• Power Of Attorney
• Application Form
• CE Design Certificate
• Declaration Of Conformity
• Schedule D (1)
• Master File Of Device
• Master Report Of Plant
• Certificate Of Free Sale
• Quality Assurance Certificate

Types of Licenses Issued by CDSCO For Manufacturing Licenses for Medical Devices

Depending on the nature of the medical device you intend to manufacture, CDSCO issues different types of licenses:

• Form MD-3: License for manufacturing for sale or distribution.
• Form MD-5: License for manufacturing for testing and clinical investigations.

Understanding which form applies to your business is important to avoid delays in the application.

Step-by-Step Application Process Of Manufacturing License For Medical Devices

What Is The Validity Period of Manufacturing License For Medical Devices?

Five Years is the validity period of the manufacturing license for medical devices. Instance if the manufacturing license of medical devices was not suspended or cancelled. Candidates can apply under 45 days from the target date.

Challenges Faced During the Application Process Of Manufacturing License For Medical Devices

The process of the medical device manufacturer registration can be challenging and the challenges include:

• Delays in Documentation: The missing and incorrect information in the application leads to the slowdown of the application.
• Facility Inspections: Failure to meet inspection standards can result in delays or even rejection of the application.
• Quality Management Compliance: ISO 13485 and GMP compliance is non-negotiable. Ensure your processes meet these standards before applying.

Costs Involved in Getting a Medical Device Manufacturing License

The costs associated with obtaining a manufacturing license include:

• Application Fees: Fees for submitting your application via CDSCO’s Sugam portal.
• Inspection Costs: Costs related to facility upgrades and meeting compliance standards during the inspection process.
• Consultancy Fees: If you need assistance in preparing documents or understanding the regulations, you may incur consultancy costs.

Common Mistakes to Avoid During the Medical Device Manufacturing Application Process

Here are some common mistakes applicants make that can lead to delays:

• Inaccurate or Missing Documentation: Ensure that all documents are correctly filled and submitted.
• Non-compliance with Quality Standards: Update your facility to meet all GMP and ISO standards before applying.
• Ignoring Risk Classification: Properly classify your device based on its risk to avoid rejections.

Conclusion

In conclusion, rigorous adherence to ISO 13485 standards and CDSCO requirements is necessary to get an Indian manufacturing license for medical devices. Safety measures are guided by risk factor categorization. Registration requires certain documents, such as a TR6 Challan and a Power of Attorney. The license has a five-year validity period, subject to renewal and compliance. Obtaining import and production permissions, as well as an IEC code, is necessary to begin manufacturing medical equipment in India. The CDSCO-mandated Form MD-1 provides information on the company and its adherence to quality management. By taking these precautions, medical device manufacture in India is guaranteed to be both legal and high-quality.

Frequently Asked Questions