How can I get BIS Certificate for an Overseas Manufacturer?

Fill out the regular application form first, and then attach all required paperwork. The next step is to designate an AIR—an authorized Indian representative—using the standard nomination form. Finally, submit these documents and the customary charge to the BIS headquarters in New Delhi.

Who Requires BIS Certificate?

Manufacturing Units effectively receive BIS Registration Certificates. But eligible goods importers and traders can also obtain this certification on behalf of their specific Manufacturing Units.

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ISI Registration Certification

ISI stands for Indian Standards Institution. ISI certification refers to the scheme under which Bureau of Indian Standards ( BIS ) grants ISI mark to Indian and Foreign manufacturers on the basis of the Indian Standard ( IS ) applicable on their product.

Advantages of ISI Certification

Who can Apply

All the Manufacturers, either Indian or foreign can apply for the licence.
In case of foreign manufacturer the licence will be granted in the name of manufacturer and it’s Authorized Indian Representative combined.

The Indian representative of the manufacturer must have a valid state drugs licence under Form 20-B/21-B or Form 41 as per the latest guidelines

Different Divisions of CDSCO
Divisions of CDSCO are as below:

1.) Medical device division ( Drugs )
2.) Drugs
3.) Cosmetics
4.) Clinical Trial on medical devices division
5.) Vaccines
6.) BA/BE

Vital Documents Required for CDSCO Registration

Documents that are required for CDSCO licence / registration completely depends of the type of application that has to be submitted i.e. they are different scheme-wise and product wise, but below are some basic documents that are to be submitted for an application of class B, C and D products for procurement of import / manufacturing licence:

You can reach our experts for complete checklist of documents required for FREE .!!

How does SunConsultants help you in CDSCO Registration ?

From collection of documents to getting the final registration / licence is an exhaustive and tedious procedure, and requires technical know-how and experience, this is exactly where Sun Consultants and Engineers come into the picture.

With over 7 years of experience in this field and after providing assistance to numerous manufacturers and importers we can help you in smoothening of this process, by complete hand-holding solution, right from the beginning of the procedure to the grant of registration/licence.

We are medical devices certification consultants based in Delhi and we assist our clients worldwide in obtaining the certifications required on medical devices in India on their variety of products.

Not only assistance in collection of documents, our experts can help you in preparation of the documents or providing with draft formats of those documents so that the application can be filed smoothly.

Timeline – Procedure

Though the timeline differs on the basis of the licence that has to be applied and the level off documentation that the Indian/Foreign manufacturer has, after submission of the application the import licence for medical devices with out assistance can be obtained in approx.6 weeks and after submission of documentation for the registration procedure we can get the registration withing the same day as that of application.

Validity

The licence is initially granted for 5 years and can be renewed after a certain time frame. There is no such validity of registration of Class-A products ( Non-measuring and Non-sterilized ) and other registrations

FREQUENTLY ASKED QUESTIONS -(CDSCO)

I. What is CDSCO

CDSCO stands for Central Drugs Standard Control Organisation (which comes under the Ministry of Health and Family Welfare), which is headquartered in Delhi, This body is responsible for all the certifications and licenses related to the above-mentioned products.

II. Where can you get a medical device import license

Medical device import licence is granted from CDSCO Headquarter which is in Delhi. An online application is to be submitted and after approval of the same the licence is grated.

III. How do I get a CDSCO certificate?

The primary stage is to see in which class ( A, B, C or D ) your products are lying and what documents are required for your product, then the application has to be filed, queries have to be resolved (ifany) and then the licence is granted. If you are an Indian manufacturer (Audit of the firm may be required)

IV. How do I register my medical device on CDSCO?

Registration of Medical devices has to be done online on CDSCO portal. Note: Registration is only applicable to medical devices which are under class A ( non- measuring and non-sterilized ), if they are class A products which measure something or are sterilized, then they will require licence.

V. Is CDSCO mandatory?

Products under class A and class B are under mandatory CDSCO certification from 1st October 2022 and products under class C and D will be under mandatory certification from 1st October 2023

VI. Which cities have zonal offices of CDSCO?

CDSCO has 6 zonal offices in India namely at Mumbai, Kolkata, Chennai, Ghaziabad, Hyderabad and Ahmedabad and various other sub-zonal offices.

VII. What type of drug applications can be submitted in CDSCO?

All types of drugs are to be certified from CDSCO, and as per the latest notifications, all medical devices are also drugs, therefore all the medical related products have to be registered or take licence from CDSCO.

ISI Registration Certification

FREQUENTLY ASKED QUESTIONS -(CDSCO)

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