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Pricing Summary :-
Market Price : ₹200000
OUR PRICE : ₹150000

25 25

Government Fee As Per Applicable

18%GST Applicable on Consultancy fees

You Save ₹50000 (25%)

PAY ONLY 50% i.e ₹75000
Rest you can pay Later

Or Ask an Expert :-
+91 7229903363

Process
1

Step1

1. Complete the Application Form

Process
2

Step 2

2. Document Processing, Preparation of form filing

Process
3

Step 3

3. Issuance of Certificate

Introduction:

The Indian medical device market is witnessing rapid growth due to an increasing focus on healthcare infrastructure and advancements in medical technology. To ensure the safety and efficacy of medical devices available in the market, the Central Drugs Standard Control Organization (CDSCO) has set specific guidelines and regulations for their registration in India. Medical device registration is a crucial step for manufacturers and importers to gain authorization to market their products in the country. In this regard, GST & IT Buddies has emerged as the best service provider, offering expert guidance, personalized solutions, and comprehensive expertise in facilitating medical device registration in India.

 

Understanding the Importance of Medical Device Registration:

Medical device registration is a regulatory process that ensures the quality, safety, and performance of medical devices available in the Indian market. It is governed by the provisions of the Medical Devices Rules, 2017, under the Drugs and Cosmetics Act, 1940. The registration is mandatory for manufacturers and importers who intend to market medical devices in India, regardless of whether they are used in diagnosis, treatment, or monitoring of medical conditions.

 

Challenges in Medical Device Registration:

The process of medical device registration in India is complex and involves multiple stages. It requires strict adherence to documentation, quality requirements, and compliance with Indian regulations and international standards. Additionally, manufacturers and importers must navigate through the classification and risk assessment of their medical devices, and any errors or discrepancies in the application can lead to delays or rejection.

 

GST & IT Buddies: The Premier Medical Device Registration Provider in India:

GST & IT Buddies stands as the best service provider, specializing in guiding companies through the process of medical device registration in India. Their team of regulatory experts possesses in-depth knowledge of the CDSCO guidelines and the Medical Devices Rules, 2017, ensuring a seamless and efficient registration process for medical device manufacturers and importers.

 

Key Features and Benefits:

  1. Expert Regulatory Counsel: The team at GST & IT Buddies comprises seasoned regulatory experts well-versed in the Indian medical device regulations. Their expert guidance ensures that companies meet all legal requirements during the registration process.

  2. Customized Solutions: GST & IT Buddies offers personalized solutions tailored to the specific needs of each medical device manufacturer or importer. They meticulously plan the registration process, ensuring compliance with the unique requirements of each medical device.

  3. Timely Execution: The medical device registration process involves multiple time-bound tasks. GST & IT Buddies ensures that all necessary paperwork and approvals are obtained promptly, minimizing any delays.

  4. Compliance Assurance: As compliance specialists, GST & IT Buddies conducts thorough checks to ensure that all regulatory obligations are met. Their proactive approach minimizes potential risks and ensures adherence to the relevant standards.

  5. Document Preparation and Filing: The registration process requires the preparation and filing of various legal documents. GST & IT Buddies assists companies in accurately preparing and filing these documents with the CDSCO.

 

Conclusion:

In conclusion, medical device registration is a critical process that ensures the safety and efficacy of medical devices available in the Indian market. Compliance with Indian regulations and adherence to international standards are paramount to gaining authorization for marketing medical devices in India.

GST & IT Buddies has emerged as the best service provider, offering expert guidance, personalized solutions, and unwavering commitment to compliance excellence in facilitating medical device registration in India. By collaborating with GST & IT Buddies, medical device manufacturers and importers can embark on this essential process with confidence, knowing that their medical device registration application is in safe hands.

As the leader in providing solutions for medical device registration in India, GST & IT Buddies continues to set the standard for compliance excellence. Their dedication to ensuring a smooth and efficient process reinforces their position as the preferred partner for companies seeking to enter the Indian medical device market responsibly and ethically.

Documents Required

1. Form 40.

2. TR6 Challan.

3. Power of Attorney.

4. Schedule D(I)

5. ISO 13485 Certificate.

6. Full Quality Assurance Certificate.

7. CE Design Certificate.

8. Declaration of Conformity

9. Free sale certificate

10. Other regulatory Approvals

11. PMS Reports

12. Plant Master file

13. Device master file


Pricing Summary :-
Market Price : ₹200000
OUR PRICE :₹150000

25 25

Government Fee As Per Applicable

You Save ₹50000 (25%)

PAY ONLY 50% i.e ₹75000
Rest you can pay Later

Or Ask an Expert :-
+91 7229903363

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