In the healthcare industry, medical devices are crucial. The medical instruments are widely used in diagnosis, prevention, and many other purposes. But how do medical stores or hospitals ensure the safety standards of this equipment? Medical devices are required to undergo mandatory registration with the CDSCO. After getting verified by the CDSCO, the mark guarantees that the instruments have undergone the stringent testing procedure. Meanwhile, the businesses that are associated with medical device manufacturing license are required to obtain the CDSCO registration certificate.
A valid device license enables businesses to operate legally in India and also protects them from potential penalties. In this guide, we will explore the process for a medical equipment manufacturing license, its requirements, and its importance. Let’s explore it in more detail.
Why Medical Device Licenses Matter for Manufacturers?
Receiving verification from the CDSCO (Central Drugs Standard Control Organization) demonstrates a commitment to public health. CDSCO certificate verification for medical devices ensures the safety of products, regulatory compliance, and market access. Here is why medical device manufacturers are required to obtain a valid license:
- Ensure Safety and Quality: In India, the manufacturing license for medical devices is issued by the CDSCO, which guarantees that the product has met established safety and quality standards. Meeting specific standards is critical to protect the health of consumers from faulty or substandard devices.
- Regulatory Compliance: In several countries, including India, securing the CDSCO registration certificate is a legal requirement. Ensuring compliance with regulations is vital to prevent penalties. A valid license demonstrates that the manufacturer has adhered to national and international standards.
- Market Access: Acquiring CDSCO approval is necessary for the lawful sale of these products in India. It showcases adherence to the global standard, which directly enhances the brand’s reputation. It facilitates the route to international markets.
- Consumer Trust: Consumers and mostly healthcare professionals preferred the CDSCO-certified devices. They gain trust and confidence when they see a relevant license with a number on the product label. This approval can significantly influence market demand and share.
- Facilitating Innovation and Research: The authority has the mandate to secure the test license. It means that, before the products are commercialized, the manufacturers can test the products or conduct clinical evaluations. It is essential to ensure that devices are safe to use and will give excellent performance. By following the clinical research steps, the manufacturers gain knowledge on how they can create more effective and safer equipment, which leads to fostering innovation.
- Prevents Legal Issues and Recalls: Selling the products in Indian markets without a medical device manufacturing license can lead to potential legal penalties. Therefore, a valid license protects manufacturers from such conditions. The certificate offers a legal structure for aligning with safety and quality standards, minimizing risks of product defects and recalls.
Primary Factors to Consider When Obtaining a Device License
Medical Equipment Classification: Classifying the risk class of the medical devices is essential before applying for a license. Determine your equipment class (e.g, Class A, B, C, or D). Classification of the devices makes the registration process more accessible.
Document Accuracy: Ensuring the details of the document and their accuracy is vital to avoid delay due to mistakes. By ensuring the accuracy of the documents, you can increase license approval chances.
Regulatory Compliance: To get the medical license and handle manufacturing premises legally, it is important to comply with GMP and ISO 13485.
State vs. Central Licensing: For medical equipment classified as Class A and B, the State Licensing Authority will issue the license. Conversely, for Class A and B devices, the Central Licensing Authority is tasked with issuing the CDSCO registration certificate.
Step-by-Step Process for Medical Device Certificate Online
The certification process for medical device manufacturing encompasses multiple steps, which include registration with the CDSCO (Central Drugs Standard Control Organization). The following is an information highlight of the steps:
Step 1: CDSCO Application Registration
Evaluate the classification of devices according to their related risks. The manufacturers are required to select the right application, such as for Class A and B, and need to fill out the Form MD-3. Additionally, for Classes C and D, manufacturers must complete Form MD-7 and apply through the CDSCO online portal. Apply to the CDSCO online portal.
Step 2: Application and Documents
To avoid delay or rejection, fill out the application form accurately. Mention the essential information like the device, the medical equipment manufacturing process, and the quality management measures. As per the regulatory authority, gather the necessary documents like the Plant Master File (PMF), Device Master File (DMF), ISO 13485 certificate if required, and various other certificates as specified in the medical device rules.
Step 3: Application Review and Queries
The submitted application by you will be scrutinized by the officials of CDSCO to ensure compliance with specific standards. If the authority finds any mistakes or missing details, they raise queries and request you to clarify them. Manufacturers are required to address any inquiries from the authority.
Step 4: Audit of Manufacturing Premises
If required for the Class A, B, C, and D devices, the notified body might conduct an audit of your manufacturing premises. They visit the manufacturing unit to ensure the availability of production. Your facilities must comply with Good Manufacturing Practices (GMP) and ISO 13485 standards.
Step 5: License Issuance and Validity
Upon successful application verification, the notified body will issue the CDSCO manufacturing license for your medical device business. The license, indeed, is valid for a designated duration. A medical device manufacturing license is valid for 5 years.
Final Discussion | CDSCO Certificate for Medical Device
Obtaining a medical device manufacturing license in India is a legal requirement. By securing the license, the manufacturers can operate their business legally, enhance brand credibility, boost consumer trust, and also facilitate international trade.
Frequently Asked Questions | Medical Device CDSCO Certificate
1. How can I get a manufacturing license for medical devices?
Ans. To secure a certificate of medical equipment, you are required to register with the relevant authority, like CDSCO, gather the necessary documents, and submit after paying the prescribed fee.
2. What is the cost for a medical device license?
Ans. The manufacturers are required to pay Rs 50,000 to obtain the CDSCO registration certificate. The fee for each device is Rs 1,000.
3. What if I do not obtain a factory license?
Ans. Operating the medical equipment factory without a license can lead to potential penalties like imprisonment or fines up to Rs 100,000 under the Factories Act 1948.
4. What is the requirement of the MD-42 license?
Ans. MD-42 is provided in the license format for medical equipment. It is officially described as the medical device registration certificate.
5. What is the license for medical equipment manufacturers?
Ans. The MD-5 Manufacturing License is required for Class A and B devices, while for Class C and D, the MD-9 Manufacturing License is required.
