FSC Free Sale Certificate | Free Sale Certificate Medical Device India

FSC Free Sale Certificate India, FSC Free Sale Certificate, Free Sale Certificate Medical Device India

If you are looking for FSC Free Sale Certification service in India, Eurotech Certification Body can Help you! Eurotech one of the Best FSC Free Sale Certification Consultant in India, if your Buyers Demanding for FSC Free Sale Certificate, you can feel free to contact us. Call: 08196980555

Free sale certificate is basically a document for certain commodities like pharmaceuticals required in certain countries. This document particularly specifies the certification that the imported goods are normally & freely sold in the exporting country's open markets and are approved for export.

The WHO induced certification for Free sale certificate scheme on the quality of pharmaceutical products so that the imported pharmaceutical products should encounter a trust of safety, effectiveness & adequate quality.

Usually WHO certification scheme includes good practices in the manufacture & Quality control of drugs.

Free Sale Certificate Scheme should enroll UPTO date list of manufacturers complying with GMP by the exporting countries.

Health Authorities of exporting countries must have the issuance of batch certificate.

There are various WHO type certificate which includes:

• Certificate of pharmaceuticals WHO (1975)
• Certificate of pharmaceuticals WHO (1988)
• Certificate of pharmaceuticals WHO (1992)
• BATCH Certificate etc.

Sually FREE SALE CERTIFICATE processes various procedures:

Example: If any country wants to export any item like any food material so it should follow these processes:

Rural payment agency should produce certificates like is it suitable for human consumption and animal consumption as well.

Human consumption must provide assurance that the product they are exporting should be safe and approved. It should not provide any harmful effects on the health.

For Animal consumption again assurance must be there in order to provide product free from radioactive elements.

Several Requirements must be followed in order to attain certification of Free sale Certificate:-

Companies must submit copies of invoices showing the sale of each product so that if in future any problem arises due to any circumstances there must be a proper submission of copies.

Manufacturer must given a written declaration to prove that its product is safe, secured and approved.

Specification of country name must be there so that no problem could be raised in future.

Documents which need to be submitted for the FSC are:

Check or verification of payment, unless a credit on account facility has been set up with the HPRA.

Proof of manufacture in the form of a notarized document.

Subsequent changes to the product listing do not need to be notarized.

 A copy of the current notified body certificates for the relevant devices.

Applications of this free sale certificate include a Secretary who can issue export certification for goods for therapeutic use in humans with the guarantee of safe and approved products.

Sometimes inspection programs are conducted in this to inspect any mistake or doubt and in return it is good program to check whether all the things that are listed must be correct.

Validity for Free Sale certificate must be included as an important part and it is 5 years from the date of issue.

Free Sale Certificate is basically a good option for the imported countries as what they want to have they can demand with proper certification and safe sight approval.

If Your Buyers Demanding for FSC Free Sale Certification Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form

all Us On: 0896980555

CE Marking Certificate for Orthopaedic products

CE Marking Certification for Orthopaedic Products in India

If you are looking CE Marking Certificate for Orthopaedic products, If your client Demanding For CE Marking Certification, or If you want to Export your product in european countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking Certification for Orthopaedic products.

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form

11 Steps in the US FDA Medical Device Approval Process | US FDA Registration Process for Medical Devices India

US FDA Registration Process for Medical Devices

Eurotech And Meddevices Certification Body Providing US FDA Certification and Registration service in India. If your client Demanding for US FDA Certification Registration, you can feel free to contact us.

All The Manufacturers, Traders, Suppliers, Exporters companies planning to sell a Medical Devices in the United States of America need to register their product with the US FDA Registration. Most Class 1 devices can be self-registered but most Class 2 devices require a 510(k) submission. For Class 3 devices, a Pre-Market submission is needed. The steps below provide a brief overview of how the PMA & (Food and Drug Administration) FDA 510(k) process work. The chart shown illustrates the (Food and Drug Administration) FDA approval process in USA.

Step 1 US FDA Medical Device Approval Process

Using the (Food and Drug Administration) FDA classification database, determine the classification of your device by researching Predicate Medical Devices already registered in the US market. Pay special attention to the three letters Device/ Equipment Code and 7 digits Regulation Number associated with the predicate Medical Equipment you identify. If no predicate found, use 513(g) / De Novo process. US FDA Medical Devices classification is made up of Class I, Class II and Class III.

Step 2 US FDA Medical Device Approval Process

Implement QMS which meets the (Food and Drug Administration) FDA Quality System Regulation found in 21 CFR Part 820. This is also commonly known as (Food and Drug Administration) FDA GMP.

Step 3 US FDA Medical Device Approval Process

Innovative Class II, and all Class III, Medical Devices will likely require clinical studies. Get Pre-Submission feedback from the (Food and Drug Administration) FDA.

Step 4 US FDA Medical Device Approval Process

If clinical studies will be required, apply for an Investigational Device Exemption. Develop clinical trial protocol and conduct studies.

Step 5 US FDA Medical Device Approval Process

For Class II Medical Devices, prepare & submit 510(k) Pre-market Notification application. Pay 510(k) / PMA submission fee. For Class III Medical Devices, prepare & submit Premarket Approval application. Pay PMA submission fee to (Food and Drug Administration) FDA.

Step 6 US FDA Medical Device Approval Process

For Class III Medical Devices, (Food and Drug Administration) FDA conducts facility inspections of all major Manufacturers /suppliers/ Exporters involved in the design & production of your Equipment. All parties must be compliant with (Food and Drug Administration) FDA QSR.

Step 7 US FDA Medical Device Approval Process

For Class II Medical Devices, the FDA (Food and Drug Administration) issues 510(k) clearance letter & posts it online. For Class III Medical Devices, the FDA (Food and Drug Administration) FDA issues PMA approval letter & posts it online.

Step 8 US FDA Medical Device Approval Process

At this time, you must be in full compliance with QSRs. The (Food and Drug Administration) FDA will not inspect Class I or II Medical device Manufacturers /suppliers/ Exporters for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance..

Step 9 US FDA Medical Device Approval Process

If you have no local presence in the US, appoint an (Food and Drug Administration) FDA US Agent representative as a local point of contact with the (Food and Drug Administration) FDA..

Step 10 US FDA Medical Device Approval Process

List your Medical Devices & register your company using FURLS system on the (Food and Drug Administration) FDA website in accordance with 21 CFR Part 807 contract /suppliers/ Exporters & sterilizers must also register & list. Specify your appointed US Agent. Your (Food and Drug Administration) FDA Establishment Registration and Listing must be renewed on a yearly basis.

Step 11 US FDA Medical Device Approval Process

You are now able to sell your device in the US. The FDA (Food and Drug Administration) listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use.

Please give us the following information to quote you:

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for US FDA Certification Registration Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form below:

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