How to Successfully Complete the CDSCO Registration Process for Your Products?

A valid license plays a crucial role in any business, whether you are in India or another country. For a specific product to sell legally, the business is required to register its service with the relevant authority. In the case of medical devices, cosmetics, or drugs, the manufacturers need to register with the Central Drugs Standard Control Organization (CDSCO). For the drug license, medical device certificates, and cosmetics, the authority acts as India’s national regulatory body. Both the DCGI and CDSCO collaborate to oversee the regulation of pharmaceuticals and medical devices throughout India.

This signifies that whoever engages in specific business as a manufacturer, importer, or distributor, obtaining the CDSCO certificate is mandatory. Still confused about the CDSCO registration steps for your product? No worries, in this guide, we will explore how you can complete the registration process, steps, fees, and much more. Let’s explore it in more detail.

What is the CDSCO Certificate in India?

For the pharmaceutical and cosmetic businesses, the CDSCO registration certificate acts as an official document. The Central Drugs Standard Control Organization allocates the certificate to product operators. The valid certificate signals to the customers that the products they are purchasing meet the specific regulatory standards and are safe to use.

In addition, the CDSCO certificate application online is also a compulsory legal requirement, as without a license, you cannot work in the Indian markets. In the case of a drug license, the manufacturers also need to register with the CDSCO. 

Easy Process- CDSCO License Apply Online 

The online registration makes the process smoother and simpler. With a one click, you can obtain the relevant license without any hurdles. However, before moving for certification, you need to understand the requirements of the authority, including document preparation, application submission, and many more. Here is step-by-step guide:

Determine the Regulatory Pathway

Whether it is cosmetics, medical devices, or drugs, determine their specific compliance with standard requirements. As per the CDSCO guidelines, classify your product and understand applicable rules.

Hire an Authorized Indian agent.

An authorized representative manages the CDSCO registration process for a foreign manufacturer. The agent will represent you in India if you are a foreign business dealer.

Prepare the Application

According to your product, fill out the application correctly. Prepare the necessary documents to attach to the application form.

1. Medical device: Form MD-14 for import license, Form MD-7 for manufacturing license
2. Cosmetics: Form 32 is required for cosmetics sales or distribution. 
3. Drugs: Depending on the specific activity, Form 20 for the sale of allopathic drugs, Form 20 B for a wholesale drug license, and Forms 21 and 21B are also necessary.

Submit the application

After preparing the required documents and completing the application form, submit it on the CDSCO online portal. Ensure that all documents are written in English and also follow the specified format. Pay the mandatory application fee and also keep proof of payment receipt.

Application review and Inspection

 An official of CDSCO will review the application form along with the provided documents. They can raise queries for additional requirements; therefore, stay active and respond to all queries promptly. To ensure compliance with the standards of the premises, the inspector may visit your manufacturing unit. 

CDSCO Certificate Granted

If your submitted application is approved by the authority, they will allocate to you a CDSCO registration certificate. Now, you are legally eligible for your products. 

Supported Documents for CDSCO Registration

• Device Master File (DMF)– Determines the technical and regulatory details of your product.
• Plant Master File (PMF)- Contains the details of the manufacturing facility.
• ISO 13485 Certificate—Outlines the compliance with quality management system standards.
• BA/BE site—Must be approved by CDSCO

Other general documents are

• Applicant identity proof
• address proof
• power of attorney
• Corporate address proof
• Manufacturing/ wholesale license
• Site and key plane of the premises

“Tips for a Smooth CDSCO Registration for Your Product”

Consult with experts: Contact a CDSCO consultant who has the knowledge and experience in the relevant subject. Their support and guidance will streamline the registration steps.

Comply with all requirements: Go through the guidelines CDSCO and align with their requirements for a seamless registration process.

Maintain accurate records: According to CDSCO guidelines, keep accurate and clear records of your business activities. 

Stay informed: Keep active with CDSCO’s new guidelines and follow their other social media pages for new updates.

Be patient: The CDSCO registration process is lengthy, and the timeline can be increased due to document errors; therefore, be patient and persistent. 

Final Words | CDSCO Consultancy for Successful Registration

To avoid legal penalties, enhance brand credibility, and boost the trust of customers, register your products with the Central Drugs Standard Control Organization (CDSCO). While the registration process can be made smoother by connecting to the CDSCO consultancy in India. For your manufacturing business, LegalRaasta can be the best choice for consultation.