Medical device regulations and FSSAI license in India.

In the coming years, the medical device market will achieve tremendous growth because of enhanced health awareness among Indian citizens. Therefore, many Medical Device Regulations in India have been imposed by the Indian government which are regulated by the Central Drugs Standard Control Organization.

Similarly, another important initiative by the government for keeping a check on the food industry business and food safety is FSSAI license. A person who wants to start a food business must obtain the respective FSSAI license. This initiative helps in decreasing food adulteration, and sale of sub-standard food products in India.

You must be wondering what the Medical Device regulations are and how they are implemented?

Medical devices in India are classified into four different categories depending upon the use of the device and the risk it carries. The regulations for each class is different and higher the risk difficult is the process of getting the approval for the device. Now let’s have a look at a different class of medical devices:

Class A-Low risk devices

Class B-Low moderate risk devices

Class C-Moderate high-risk devices

Class D-High risk devices

For obtaining a medical device license, the concerned person has to apply using the government of India online portal, following which the respective third-party entities of government will do the required verification of the devices and their manufacturing sites to confirm whether they fulfil the standards set by the Quality Management System and Bureau of Indian Standards. After proper verification and formalities license will be issued.

However, for a medical device which is new to Indian market, should undergo proper clinical investigation for getting the license.

Food License

As we all know a person who is intending to start a food business must obtain an FSSAI license, then let’s discuss a little on two major types of FSSAI license and how they differ?

Well! An FSSAI license is categorized depending on the total turnover of the business. A business whose annual turnover is less than 20 crores must obtain a FSSAI state license and it is governed by state government authorities. Similarly, a business whose annual turnover is more than 20 crores must obtain FSSAI central license to start his food business. This license is governed by the central government. The applicability of these license also depends on the food activity conducted by the Company filing for license.


Now let’s throw some light on the process to obtain FSSAI license.

For a person thinking of starting a food business, should obtain the FSSAI license first. For that, he has to go through a systematic process of applying in government website along with submission of documents following which a detailed verification will be done by government authorities and then the license is issued. This takes a long time. But with FSSAI license consultant you can easily get the license within 15-20days. All you have to do is submit the required documents.

Thus, if you are in a hurry to start your food business OR want to sell and distribute medical devices, then one of the better options is to hire a license consultant who can help you in getting your license more rapidly that too without much of your involvement.

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