CDSCO Extends Import Deadline for Medical Devices
NEWS FLASH: According to the latest news, the Indian government has recently advertised the idea of a six-month extension to the importers or manufacturers about the risks associated with medical devices, including those, who have already applied for the licenses.
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In continuation to this news, the Central Drugs Standard Control Organization (CDSCO) has come forward with the stated deadline of October 1, especially for the Class C and Class D medical devices, inclusive of medical devices, imaging equipment, ventilators and surgical robots, as per the proposed regulation. Essentially, this new regulation oversees the medical devices in India, summoning devices under the following category that cannot be circulated or sold without a manufacturing license in accordance with the issued deadline.
The manufacturers have even raised issues regarding their advanced license applications and the resulting deadlines.
Know the Categories Of Medical Devices
We understand the categories of medical devices but fail to distinguish between their types. As we roll back to the year 2017, we discuss the list of medical devices that fall under this bracket of Class A, B, C and D, which are counted under the New Medical Device Regulations (MDR).
It depends upon the level of risk, posed by them that class A and B devices are categorized within low-risk categories or moderate-risk devices. Accordingly, Class C and D devices come under the category of high-risk devices, whereas Class C and D devices are classified as high-risk and extremely high-risk devices.
Now, if you wish to get it approved for a manufacturing license in India, the manufacturers belonging to class C and D devices are required to submit an application, mainly to the Central Drugs Standard Control Organisation (CDSCO). For instance, CDSCO undertakes the application process and even issues the import licenses, especially for the devices falling under the Drugs and Cosmetics Act of 1940.
To furnish the statement as per CDSCO Verdict, it said the following statement in a circular which highlighted-
It has been decided that, in case an existing importer/ manufacturer who is already importing/ manufacturing any of the above said Class C or Class D Medical Devices, has submitted an application to the Central Licensing Authority, for a grant of import /manufacturing licence in respect of the said devices) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) for up to six months. From the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, whichever is earlier,” said a CDSCO circular dated October 12.
AiMED Urges Timely Implementation of Inspection and Manufacturing License Issuance
Along with this, the Association Of Indian Medical Device Industry (AiMED), representative of the domestic medical device makers, even hinted at and requested for acquiring an extension of the deadline.
In a letter addressed to Health Ministry Mansukh Madaviya, dated September 25, AiMED accentuated the constraints subjected to CDSCO in coming up with the implementation related to the timely inspections as well as the issuance of the manufacturing license within the concerned deadline.
Whereas, as per the circular issued by the government dated 12th October, declares and allows manufacturers (all those, who have applied for licenses already to carry out manufacturing as well as importing of medical devices, within the relaxation provided for as much as 6 months, from the issuance of government's order, or until Central Licensing Authority makes a decision on the application.
In short, the decision is yet to be made, but within this tenure, the medical device industry is summoned to carry out the operations, until the license approvals are issued and communicated to the medical fraternity.
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