CDSCO stands for The Central Drugs Standard Control Organization. It is basically a National Regulatory Authority operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Medical devices are freely imported into India. To ensure the quality of the product being imported into the country Government of India has developed regulations and guidelines.
Let's first see what is Medical device.
Any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for helping in disease, injury or disability, replacement or modification of the anatomy or for providing information by in vitro examination, without pharmacological, immunological or metabolic.
Medical devices are broadly divided into two parts Notified and Non-Notified
The CDSCO also classifies the medical device as per the risk parameter and intended use i.e Class A, B, C, D.
Class A Medical devices are low risk Medical device
Class B is Medium risk
Class c is medium to high risk
Class D is High Risk
Medical devices entering into Indian Market must be in compliance with guidelines set forth by the #cdsco O
All medical devices imported into India #medicaldevices #import License is required. If any medical devices are imported into India without getting Registration.
There was an amendment in Medical Device Rule 2017 in February 2020 referred to as “Medical Devices (Amendment) Rules 2020 now all the devices whether notified or non notified requires CDSCO registration.
Now see the Application procedure as per CDSCO guidelines
• An Authorized agent having a valid license to manufacture for sale or distribution or wholesale License for same can apply for an application for grant of import License for Medical Device to the central licensing authority online in form MD14 on the portal of Ministry of Health and Family Welfare for obtaining a license.
• If the central Licensing authority has a reason to believe that the quality of the medical device has been compromised, then it is subjected to go through test & evaluation in the testing laboratory as specified by the Central Licensing Authority.
• After evaluation of the application form and documents, if the central licensing authority is satisfied, it will grant a License to import in form MD 15. If the authority is not satisfied, it may reject the application, and the reason for rejection is required to be recorded in writing within nine months from the date of application.
• If the application is rejected, an applicant can make an appeal to the Central Government within forty-five days from the date of rejection and the Government, after an enquiry in this matter, pass an order in relation there within ninety days from the date of appeal.
Moving forward let us understand Whether Components and accessories imported also require Registration as per CDSCO Guidelines.
As per CDSCO, components and accessories imported need not be registered separately. However, what separately means is not clear. All components and accessories should be registered because, in the registration form, details of components and accessories are required to be filled if any components and accessories are not registered as Medical Device for some reason, then they need to be registered as ‘Medical Device’ as per the definition of Medical Device mentioned in the Act.
The basic Documents required for Registration are
1 AN ISO 13485 certificate,
2 certificate to Foreign Government or Free Sale Certificate and
3 an undertaking stating that the information and documents submitted are true to their knowledge and are authentic.
Let see what are the Consequences of Non-Registration as Per CDSCO Guidelines
A device that is required to be registered cannot be imported into India without Registration after October 1, 2021. The importers need to get Registration done before they import medical devices to India.
Devices imported after October 1, 2021, if not registered, will invite penal action under The Drugs and Cosmetics Act, 1940.
In the last we can say with the increasing demand for import and export of medical device in & from India, Government has been coming up with new policies to make the such process easy and smooth. The Registration for import of Medical devices is mandatory to process, and it must strictly be as per Central Drugs standard control organization.
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