CDSCO Procedure for Medical Device Import License in India

The importation of goods and services serves as the most efficient method to enhance international trade. Suppose India wants to import medical devices; it first needs to align with the national authority. While this is not only mandatory in India but also in other countries. Talking about the medical device import in India, the business is required to register with the national body, which is the CDSCO in India. 

This signifies that the medical device business cannot trade internationally without the CDSCO certificate. But what is the procedure for a device import license, and how can importers obtain it? No worries, because in this blog, we are going to shed light on the steps of the CDSCO certificate for import to regulate the business of medical devices. Let’s explore it in detail.

Why CDSCO License required for Medical Devices? 

The CDSCO license is crucial for pharmaceutical products in India. The registration for medical devices ensures the standards of safety and quality. Before importing products in India, they need to meet specific regulatory standards. The aim is to establish the rules and regulations to protect consumers from unsafe and substandard equipment. Here is why the medical device CDSCO registration certificate is required in India:

• Public Health Protection: The method of product licensing was introduced to protect the health of the public. The certification only allows safe, effective, and high-quality equipment. The unregistered equipment can cause potential injury or infection. 
• Regulatory Compliance: The medical device registration is a legal formality that is required to be followed by all importers. Whoever wants to trade in India should adhere to the regulatory authority requirements. The registration determines that the manufacturer and the importer are aligning with specific standards. 
• Accountability and Traceability: Licensing serves as a mechanism to oversee the operations of importers. This means they themselves are responsible for device safety and performance. CDSCO has access to track the market operations, including the manufacturing process and importation. 
• Market Access and Credibility: To participate in government tenders as well as private ones, you need to obtain the CDSCO certificate for import. The registered medical device importers can trade independently in competitive markets. It further enhances a company’s credibility. 
• Promoting Ethical Manufacturing: By encouraging the importers to comply with the best practices in production, design, and control, improve the ethical manufacturing practices. 

Step-by-Step: Process for Medical Device Import License

The CDSCO registration for a medical device involves several steps. You need to follow:

Step 1: Application Registration 

Register your medical device import business with the CDSCO official online website. To obtain the import license, it is necessary to complete Form MD-14.

Note- For application registration, visit the CDSCO’s SUGAM online portal.

Step 2: Documentation

Gather the specified and necessary documents, including a wholesale license copy (Form 20B or 21B or MD-42), a free sale certificate, and other major required certificates. Make the online payment and keep the payment receipt as proof.

Step 3: Application Review 

The submitted import license application with documents will be reviewed by the CDSCO. If required, the official will conduct a premises inspection or a foreign manufacturer’s facilities. They will ensure your manufacturing process, storage facilities, and other compliance.

Step 4: Import License Issuance

If CDSCO is satisfied with the application accuracy and the certificates, a CDSCO certificate for medical device import will be issued in Form MD-15. 

User Query: Mistakes To Avoid During Medical Device Manufacturing Certification

What are the Key Considerations?

• If a foreign manufacturer wants to monitor the importation of medical devices in India, they need to appoint an authorized Indian agent. You can also contact a distributor who has a valid wholesale license.
• As devices are divided by their risk factors, determine your medical device (e.g., Class A, B, C, or D). 
• The license approval typically takes 3 to 6 months. However, it depends on the application accuracy and device complexity.
• The medical device import license, recorded in Form MD-15, is valid for only five years. Before its expiry, you need to apply for license renewal. 

Final Words | Medical Device Import License in India

To obtain the CDSCO certificate for the import of medical devices, importers need to register with the relevant authority. Following the CDSCO certificate apply online process for medical device import, reduce the time wasted and physical visits to the authority offices. The guidance and support of a consultant can reduce the hurdles of registration steps.