CDSCO Certification For
Medical Devices

This firm holds the responsibility for approving as well as regulating the medical equipment as well as clinical trials within the nation. Also, it sets the standards for the quality of imported medical devices, and coordinates the activity of State Drug Control Organizations.

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CDSCO Registration

1. Application Filling

On your behalf, we complete the CDSCO Application Registration form.

2. Payment

Make payment to our team.

3. Document Submission

Please send us the appropriate documents.

5. Registration Issuance

We will mail you a copy of your Registration Issuance.

What is CDSCO Registration

The medical equipment that is being imported into our country must adhere to the regulations laid down by the CDSCO agency. This firm holds the responsibility for approving as well as regulating the medical equipment as well as clinical trials within the nation. Also, it sets the standards for the quality of imported medical devices, and coordinates the activity of State Drug Control Organizations. It is mandatory for the medical equipment that is being imported to the Indian subcontinent to adhere to the legal medical device regulation that is being put forward by the authority CDSCO. This regulatory body holds the responsibility for the approval as well as regulation of medical equipment as well as the clinical trials within the nation and lays down the drugs& medical device control standards with respect to the quality, as well as the state drug control organization coordination.

Categories of medical device registration

Any Indian business that is either manufacturing or importing medical products registration as per the notified list of the 37 of the total medical equipment, is required to seek CDSCO Certification.Two distinct categories are specified for each type of licensing that the applicant is looking forward to. Here are two types of application forms:

Importer

This category holds for any Indian business looking forward to manufacturing and selling medical devices within the country. They are required to fill application for CDSCO import licensing under the application form, MD-14

Manufacturer

This is meant for businesses that intend to manufacture as well as further sell medical equipment in the country. They are required to fill out application form 3/ Form 7 for medical equipment manufacturing licensing under CDSCO.

Documentation needed for CDSCO Registration

Here is the paperwork which is needed for the CDSCO registration:

Identity Proof.

Proof of address.

BA/BE site registration copy( approved by the CDSCO under the condition of BA/BE approved site).

Undertaking secured from Governmental authority.

Manufacturing licensing under the condition of importer/ manufacturer of goods.

Procedure

1. Finding if your product needs registration

2. Appointment of authorized agent( Indian national)

3.Submission of regulatory Dossier( under Form 40)

4.Obtaining registration certification in Form 41

5.Seeking import licensing in form 10

5.Marketing Product in India

Process of CDSCO registration for medical devices

1. This step involves the determination of the product to be registered

Currently, there are 22 of the notified medical device import license, under the Drug & Cosmetic Act, 1940. So such devices need to be registered with the CDSCO authority.

2. Appointment of authorized agent( Indian)

As per the regulations in Indian, there is a need of foreign manufacturers for appointing authorized agents, Indians for registering themselves with CDSCO on their own behalf.

3. Submission of regulatory Dossier as per Form 40

A dossier list needs to be prepared for beginning the registration procedure. There is a need for the submission of documents & payment fee. The fee for CDSCO Registration for medical devices for single-unit manufacturing sites is US $ 1500. For a single device family fee is US $ 1000.

4. Seeking Registration Certification, Form 41

Once documentation submission is done, the CDSCO authority will get back to the Indian agent through their first query letter within 3 months of time. Once answers are received from the query, the authority will either be issuing another subsequent query letter or grant licensing.

5. Seeking Import licensing, Form 10

Form 10 needs to be applied at the CDSCO authority. The application needs to be filed through Form 8 and Form 9, with the mention of the registration certification number. This procedure will take 4-12 weeks.

6. Product Marketing in India

After the registration certification as well as the import licensing will be issued, the product can now be entered into the Indian market. The authorized agent from India will be reporting any sort of changes, adverse impacts, and recalls in other nations as & whenever it is taking place.

Testimonials

This company has helped me with my CDSCO registration fast! Everything is well coordinated and went smoothly! Thanks!

- ROHIT SHAKULA

I am glad i found this company. The staff is supportive and assisted me in securing the CDSCO licensing fast! Very satisfied with their service! Highly recommended!

- SAURAV VERMA

The company provided me with the best solution for my CDSCO licensing. I got end-to-end service with full support! I am thankful for their help!

- RAMESH KHUSHAL

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FAQ’S

Any individual/firm or company that is holding wholesale licensing or manufacturing licensing, with issuance under the Drugs & Cosmetic Act, 1940 & Rules, 1945 can apply for CDSCO Registration for medical devices.

A registration Certificate unless and until it gets suspended/ cancelled earlier shall hold validity for duration of 3 years from the date of issuance.

A fee amounting to US $ 300 shall be paid for securing a duplicate copy of the registration certification under the condition when the original document gets damaged/lost.

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CDSCO Certification For Medical Devices