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.
On your behalf, we complete the CDSCO Application Registration form.
Make payment to our team.
Please send us the appropriate documents.
We will mail you a copy of your Registration Issuance.
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.
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:
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
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.
Here is the paperwork which is needed for the CDSCO registration:
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.
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.
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.
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.
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.
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.
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