Manufacturing of Class C and Class D Medical Devices in India: Procedure and Document

Overview of the Indian medical device manufacturing industry

India’s medical device manufacturing industry is growing rapidly and is expected to reach $50 billion by 2025. The Indian Government focused on supporting the manufacturing sector through several initiatives like ‘Make in India’ has given a boost to this industry. The government promoting the manufacturing sector and the availability of skilled labour provide a conducive environment for the growth of the industry.

The Indian government has implemented various policies and initiatives to promote the medical device manufacturing industry. This includes the rules on medical devices for 2017 which aim at improving the quality and safety of medicinal products sold in India. In order to support the development of the Indian medical device industry, the government has also set up a National Medical Device Promotion Council.

Understanding Class C and Class D medical devices

In India, medical devices are classified on the basis of their risk to patients and users. Medical devices are classified according to a classification system of four categories A, Class B, Class C and Class D which is the highest-risk category that requires more rigorous regulation than less risky ones.

In India, Class C medical devices are those which are used for a short period of time, typically less than 30 days, and have a moderate risk to patients and users.

Examples of Class C medical devices, such as surgical instruments, catheters and implants.

Class D medical devices in India are products that have been used for a long period of time, usually longer than 30 days and pose a high level of risk to patients and users.

Examples of Class D medical devices include pacemakers, heart valves, and other implantable devices.

Challenges faced by manufacturers in India, including infrastructure and regulatory barriers

Infrastructure challenges
Regulatory challenges
Access to financing and credit
High taxes and customs duties
Limited availability of skilled labour
Poor intellectual property protection
Inefficient bureaucracy and corruption

The role of the Central Drugs Standard Control Organization (CDSCO) in regulating medical devices

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India. The Commission shall be responsible for ensuring the safety, effectiveness and quality of medical devices in this country.

The CDSCO’s role is crucial to ensuring the safety and effectiveness of healthcare products for patients in India. It regulates the manufacture, import and sale of medical devices and establishes standards for testing, labelling and packaging of these products. The CDSCO also works closely with other national and international regulatory bodies to ensure that Indian medical devices meet global standards for safety and quality.

The regulatory process for medical devices in India is complex and multifaceted, and the CDSCO is responsible for overseeing each stage of the process. This includes:

Registration and licensing: All medical devices must be registered with the CDSCO before they can be placed on the market or sold in India. The CDSCO reviews applications for registration and issues licenses for the manufacturing and import of medical devices.
Standards development: The CDSCO created standards for the testing, labelling, and packaging of medical devices in India. Standards for testing, labelling and packaging of medicinal products in India shall be developed by the CDSCO. These standards help ensure that healthcare products comply with minimal safety and quality requirements.
Post-market surveillance: In order to ensure that they continue to comply with safety and quality standards, the CDSCO will monitor medicinal products which are now on the market including conducting inspections of manufacturing facilities and investigating complaints and adverse events associated with medical devices.
Enforcement: The CDSCO shall be empowered to take enforcement actions against producers and importers of medicinal products which are in breach of their legal requirements. This can include issuing warning letters, revoking licenses, or taking legal action against companies that are found to be in violation of the law.

Document required for manufacturing of class C and Class D medical device

The manufacturing of Class C and Class D medical devices in India is subject to regulatory requirements under the Medical Devices Rules, 2017. Below are some of the documents required for the manufacturing of Class C and Class D medical devices in India:

Manufacturing License
Device Master Record (DMR)
Design Control Documents
Quality Management System (QMS) Documents
Device History Record (DHR)
Clinical Evaluation Report (CER)
Labelling and Packaging Documents
Device Testing Report
Risk Management Report
Stability Testing Report
Non-clinical Study Report
Clinical Investigation Report
Import License
Test License

Procedure for obtaining a license for manufacturing of class C and Class D medical device

Step 1- The first step is to identify the Class C or Class D medical device that you want to manufacture.

Step 2- The next step is to establish a manufacturing unit that complies with the applicable standards and regulations including infrastructure, facilities, and equipment to manufacture the medical device

Step 3- Prepare the license application and the necessary documents

Step 4- Submit the application to the Central Drugs Standard Control Organization (CDSCO)

Step 5- The CDSCO will review the license application and conduct an inspection of the manufacturing unit to ensure compliance with standards and regulations.

Step 6- If the CDSCO is satisfied with the license application and inspection, it will grant a license to manufacture the medical device.

Conclusion

This blog is all about the manufacturing of class C and class D medical devices. Along with an overview of the Indian medical device manufacturing industry and an understanding of medical device class C and class D. Also the procedure and documents for manufacturing medical device class C and class D. Hope this blog will help you understand the class C and class D medical devices.

Posts, V. M. (2023, April 28). Manufacturing of Class C and Class D Medical Devices in India: Procedure and Document. Legal Compliance. https://legaladvisoryservice.wordpress.com/2023/04/28/manufacturing-of-class-c-and-class-d-medical-devices-in-india-procedure-and-document/

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