The Indian Medical Device Regulation established by the CDSCO must be complied with by medical devices entering India. The CDSCO is in charge of setting drug standards, monitoring the quality of imported medicines, and coordinating the work of state drug control organizations. It also approves new treatments and oversees clinical trials across the nation.
According to CDSCO's recent guidance, if the importer misses the deadline, CDSCO may suspend or terminate the Class A and B medical device licenses. For the purpose of awarding licenses for medical equipment brought into the nation, CDSCO has established a thorough process. This process is applicable when we bring medical equipment into India from another nation.
However, they must be categorized in accordance with the CDSCO's list of notified devices. Previously, manufacturers could sell their medical devices in India without having to adhere to any particular laws or rules, but as of 2006, CDSCO's import regulations for medical devices into India are mandatory.
License Procedures for Medical Device Imports
· The following requirements must be met before registering:
· Name of the Generic, Brand, and/or Objective
· Application techniques and building materials
· assessing the item's details and categorizing it in accordance with the CDSCO-notified product list.
Phases of Import License Registration
CDSCO Any company or individual with a license (granted under the Central Drug Standard Control Organization (CDSCO), Drugs and Cosmetics Act, 1940) and possessing a wholesale and/or manufacturing license may import medical devices into India.
Foreign producers are now required to apply for registration certificates for both their manufacturing facilities and the specific pharmaceuticals they intend to import. Authorized agents of international companies are permitted to submit the applications in India.
The modifications make clear what paperwork is needed for registration certificates. From the moment they are issued, registration certificates are valid for 3 years.
Phases in CDSCO Import License Registration:
Phase I – Applicant Registration
Phase II – Import License application
· Phase I – Applicant Registration:
After submitting an application, a client will have an active account on the CDSCO online registration portal. The Central Licensing Authority must receive an application for grant of import license for medical devices through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14.
The authorized agent (who must have wholesale license for local distribution) must have license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules.
Procedure of phase 1:
Submitting forms online.
The delivery of the necessary papers.
Consent from CDSCO.
If a request is denied, CDSCO will explain the situation and, if required, request another application.
· Phase II – Import License Application:
Import License Application: To be able to import medical devices for commercial use, this license is necessary.
Procedure of Phase 2:
Submission of an online form with all relevant information, such as the device's categorization, brand, intended usage, and product description.
Putting the files online.
To be paid fees.
A change in the application's status.
If there is a question, the correct response or updated papers must be uploaded.
ACPL helps their clients in making technical dossiers for the import licensing of medical devices in India, we also solve the queries raised by the regulators, and we also provide system implementation, training, licensing, regulatory approvals and certifications.
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