Medical Devices entering to India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations.
As per the new Guidance of CDSCO, suspension and cancellation of the Class A & B medical devices may happen if importer fails to meet the deadline specified by CDSCO. CDSCO has set a complete procedure for granting license for medical devices imported in the country. This procedure is applicable when we import medical devices from other countries to India. However, they need to be classified according to CDSCO notified devices list, Earlier manufacturer were able to sell their medical device in India without following any specific rules and regulations but from 2006, medical devices entering to India need to follow specific import guidelines set by CDSCO.
Pre-requisites for registration process:
CDSCO Import license for medical devices is regulated in India that any industry or an individual having license (wholesale and/or manufacturing license issued under central drug standard control organization (CDSCO), Drugs and cosmetics act, 1940 and can import medical devices into India.
Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued.
After applying Client will have an active account on CDSCO online registration portal. An authorized agent (who must have wholesale license for local distribution) having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license.
Procedure of phase 1
This license is required to have permission to import medical device for commercial purpose.
Procedure of Phase 2
Lockene is the leading medical device regulatory consulting company. We help our clients in making technical dossier for the import licensing of medical devices in India, we also solve the queries raised by the regulators, and we also providie turnkey services, system implementation, training, licensing, regulatory approvals and certifications.
Many times, rejections or need of re-submission has been seen due to incomplete information or wrongly submission, to avoid rejections and delay in projects get expert guidance and follow a correct procedure for better results.
In India, the cosmetic industry is rapidly growing, with a massive market for cosmetic and personal care products. The import of cosmetics in India should be regulated to ensure the quality, safety, and performance of cosmetics being imported into India needs CDSCO Cosmetic Import Registration Certificate from the Ministry of Health & Family Welfare as prescribed under Rule 21 Of Drugs And Cosmetics Rule 1945. The certificate is required from the primary regulatory authority for CDSCO Cosmetic Import Registration in India, which is obtained from the Central Drug Standard Control Organisation (CDSCO). With this registration, import activities and sales of cosmetic items can be carried out in India without any hassle. In India, CDSCO Cosmetic Import Registration in India is governed under the Drugs and Cosmetics Act, 1940.
Cosmetic means any substance which is aimed to be scrubbed, sprayed, poured, or introduced into the human body which is used for altering, cleansing, or beautifying the appearance, which also includes any article used as a part of cosmetic products.
According to the Drugs & Cosmetic Act, 1945, CDSCO has listed the applicants who are eligible to apply for CDSCO Cosmetic Import Registration in India:
Following are some vital documents required at the time of CDSCO Cosmetic Import Registration:
*Note: All The Documents Are In The English Language.
Following is the step by step procedure for CDSCO Cosmetic Import Registration in India:
Step 1: Determination Of Cosmetics Classification: When a manufacturer decides to register their products in India, then the manufacturer must check the Gazette Notification of CDSCO prior to making a final determination of a device’s regulatory status & classification.
Step 2: Appointment Of An Indian Agent: The manufacturer should appoint an authorised Indian agent to interact with the CDSCO. The agent will be granted a Power of Attorney to assist in cosmetic approvals and manage registration & importation in India.
Step 3: Fill Out The Application Form For CDSCO Cosmetic Import Registration: After appointing an agent, the importer or manufacturer of cosmetics shall be required to submit the Registration Form along with all the documents and prescribed fee on the CDSCO website to the Drug Controller General Of India (DGCI) by simply logging on to the online website of CDSCO and signing into the website.
Step 4: Issuance Of CDSCO Cosmetic Import Registration Certificate: Once the application form along with documents & fee is submitted on the website of CDSCO, the DGCI Registration Authority may send a query via an inquiry letter to the manufacturer or from the certified representative of the importer. Once the authority is fully satisfied with the application, then they may issue a Cosmetic Import License.
Lockene assists in applying CDSCO Cosmetic Import Registration Certificate. The applicant may find it difficult to comply with documentation and requirements, as we mentioned above. So in such a case, it is recommendable to contact Lockene, who will definitely guide you on each step of the procedure.
cdsco | cdsco registration | cdsco website | cdsco certificate | cdsco office | cdsco license | cdsco import license | cdsco online registration | cdsco import license | cdsco certification| cdsco official website | cdsco registration certificate | cdsco medical devices| cdsco medical device registration | medical device certification | cdsco license consultant| cdsco approved medical devices | cdsco medical device online| cdsco registered medical device | cdsco registration of medical devices