How To Apply For Medical Device Registration In India?

A medical device can be an instrument or anything as unexpected as a software. It may be used alone by itself or along with some other device. It may be used for treatment or preventative functions. Whatever the kind of device it is, before you can manufacturer or import it for selling or distribution, you will have to apply for Medical Device Registration in India. This guide covers the registration process and requirements.

Registration or NOC

There are around four dozen medical devices which require registration in India. So you should check whether the device you plan to introduce requires registration or an NOC. If it doesn't require a registration, you will have to apply for a No Objection Certificate (NOC) with the appropriate authority. This NOC will state that your product doesn't require Medical Device Registration in India and you can import it into the country.

Regulatory Authorities

There are different types of medical devices and drugs. You will have to apply to the following authorities for Medical Device Registration in India:

• CDSCO – The Central Drug Standards Control Organization is the primary regulatory authority for medical devices and pharmaceuticals.
• DCGI – The Drug Controller General of India is a part of the CDSCO that regulates the approval of manufacturing of drugs and medical devices in the country.

The import, manufacturing, sales and distribution of medical devices in India is regulated under the Drugs and Cosmetic Act and Rules. Even when you need a license for cosmetic import India, you will have to follow a similar process and apply to the same authority.

Registration Process

It will be helpful if you already know the basic steps involved in the registration process. However, it will be best to get the help of a Pharma regulatory consultant India to ensure that the documentation and other requirements are complete and that there are no delays.

• You should apply for registration with the DCGI
• If you are introducing a new medical device, it will be required to get prior approval even before you can apply for registration
• Once your application for Medical Device Registration in India is received along with the fees, the authority will evaluate it
• The authority may ask for clinical testing
• The authority may also visit your manufacturing facility

The term ‘medical device’ can be quite complicated. Anything can be considered as a medical device, even a software used for treatment, diagnosis or prevention of a condition.

Cosmetic Products

Even when you want to register a product meant for cosmetic import India, it will be required to apply for appropriate license with the DCGI. There are a wide range of application forms for different types of products, so it is best to get the help of a consultant to ensure that you meet the documentation requirements. Usually, it takes 6 months for the registration certificate to be issue, but it can take longer based on the product and any delays.

So whether you want to register a medical device or a cosmetic product for import or manufacture, you will have to apply to the CDSCO. Such a product can be classified under a specific category. It is best to get the help of a Pharma regulatory consultant India to ensure that you are well prepared for the registration process and that there are no delays.