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What Is The Process For Cosmetic Import & Medical Device Registration In India
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If you are a manufacturer or importer of an item that falls under the category of medical device in India, you should get the appropriate FSSAI State license to be able to introduce it into the market. Even if you are introducing a cosmetic product that falls under the category of medical device, you will have to complete the registration process. This guide will provide you valuable information as to how the process goes.
When it comes to medical device registration in India, it takes anything from 6 to 9 months for the process. You will have to submit the complete documentation along with the fees to get the registration certificate. Once you have obtained the registration, it will remain valid for a period of 3 years. It is important to submit the application of renewal 6 months before the registration expires.
The Drugs and Cosmetics Act, 1940 and Rules, 1945 are the relevant laws concerning medical devices. It regulates all aspects of introducing such a product in this market, including:
There are wide range of medical devices that should be registered before being introduced into this market. This includes items ranging from syringes and needles to something as complicated as spinal needles. You will have to register the device with the CDSCO. In fact, it is up to the authority to determine which item falls under the medical devices category and needs to be registered. So it is important to have the item reviewed before you plan to introduce it into this market. It can take anything from 1 to 3 months to complete this review process to determine whether medical device registration in India is required for the item or not.
If you plan to import cosmetic products into India, you will have to apply for appropriate licenses. Registration for cosmetic import India involves careful planning and review of the product and its ingredients. You will also have to be careful abut the labeling. The application for the registration should define the products against the appropriate categories.
If you want to manufacture and sell cosmetic products in India, you will have to apply for the following licenses:
• Form 32 license for the manufacture of cosmetics for sale and/or distribution.
• Form 32-A license if you want to get a loan license for the manufacture of cosmetics for sale and/or distribution.
• Form 37 license if you want to get approval for conducting tests on cosmetics, drugs or raw materials used in manufacturing.
So whether it is a medical device or a cosmetic product that you want to import or manufacturer in India, you should get the proper licenses. Applying for FSSAI State license can be a complex process. So it is always beneficial to get the help of an agency that can provide support with the process. It can take months or even a year for the process to complete, so you should seek professional aid to ensure that all the documentation is accurate to prevent any delays.
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