Apply Now – Assam Medical Device Sell, Stock, Exhibit Registration Certificate in Assam

Application for Registration to Sell, Stock, Exhibit, or Distribute Medical Devices, including In Vitro Diagnostics in Assam

Are you looking to sell, stock, or exhibit medical devices in Assam? Ensure compliance with regulatory requirements and apply for a registration certificate through Sewa Setu.

Benefits

• Legitimacy and credibility
• Compliance with Medical Device Rules, 2017
• Enhanced reputation
• Streamlined application process
• Increased transparency and accountability
• Patient safety assurance

Eligibility Criteria for Registration Certificate to Sell a Medical Device in Assam

• Business registration certificate
• GST certificate
• PAN card
• ID proof (Aadhaar card, Passport, etc.)
• Medical device certification (ISO, CE, etc.)

Documents Required

1. Self certificate of compliance with respect to Good Distribution Compliance
2. Identity Proof, such as, Aadhar card or PAN Card.
3. An undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied.
4. Details of the applicant or firm including its constitution
5. Documentary evidence in respect of ownership or occupancy on rental of the premises.
6. Brief description on other activities carried out by applicant namely, storage, of drugs , medical items , food products , stationeries etc. or any other activities carried out by the applicant in the said premises.
7. Details of competent technical staff, under whose direction and supervision the sales activity of medical devices shall be undertaken who shall possess the following educational qualification and experience namely-
   • a) Hold a degree from a recognized University / Institution: or
   • b) Is a registered Pharmacist.
   • c) Has passed intermediate examination or its equivalent examination from a recognized Board with one –year experience in dealing with sale of medical devices.

Step-by-Step Guide Application for grant of registration certificate to Sell a medical device

1. Visit Sewa Setu Assam website (Click Here)
2. Click on “Public Services” and select “Medical Device Registration Application”
3. Register/login with your credentials (Aadhaar number)
4. Fill the online application form
5. Upload required documents
6. Pay the applicable fee online (if any)
7. Submit and print the acknowledgment

Stipulated Time Limit :

• Not Mentioned

Fees:

• Rs. 3000/-
• ONLINE: The requisite fees to be paid through EGRAS payment gateway only.
• OFFLINE:The Head of Account is “0210-Medical and Public Health, 04- Public Health, 104-Fees and Fines”.

Common Mistakes to Avoid

• Incomplete or inaccurate information
• Insufficient documentation
• Delayed application submission

Additional Tips and Contact Information

• Ensure compliance with Medical Device Rules, 2017
• Maintain accurate records
• Update product information regularly
• Verify the authenticity of documents
• Sewa Setu Assam website: (Click Here)

Conclusion

Apply for your Assam medical device registration certificate online through Sewa Setu and heal your business.

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Frequently Asked Questions (FAQs)