To manufacture/import those medical devices which do not have predicate devices, one needs to fill out the form MD-26, whose permission is granted in form MD-27. Since these devices are of a new kind, the manufacturer/importer needs to have enough evidence to support that medical device is safe to use, have better quality, and are efficient.
When anyone decides to get manufacturing/import license for new medical devices in India, the predicate device is first to check. If there is a predicate device, it works on substantial equivalence; if not, it is considered a new medical device or medical device without a predicate device
Medical Device – As per the medical device rule,2017 Medical Device is defined as:
If the medical device falls under the category of a medical device with no predicate device and someone wants to manufacture or import it, then they must fill out l the form given below:
Application form | Permission from | Class | Fees | Licensing authority |
Form MD-26:Application to import/manufacture for sale or distribution of medical device that does not have predicate medical device. | Form MD- 27:Permission to import or manufacture for sale or distribution of medical device that does not have predicate medical device. | A, B, C, and D | Rs. 50k | CDSCO |
Predicate Device: As per the medical device rule,2017 predicate device means first of its kind device which was approved for the first time for manufacture, sale, or import by the Central Licensing Authority. Predicate devices have similar purposes, the same material used in construction, and design characteristics to the device being proposed for the license.
Step 1: Classify the device into a risk-based class
Step 2: Appoint the authorized agent (if the manufacturer is foreign-based)
Step 3: Check if it has a predicate device
Step 4: Fill out the form MD-26
Step 5: Pay the fees challan
Step 6: Submit the documents
Step 7: The CDSCO will review the documents
Step 8: Discussion Meeting to work upon the application.
Step 9: there are two scenarios now
Summary: For manufacturing/import license for new medical devices which do not have predicate devices, one needs to fill out the form MD-26, whose permission is granted in form MD-27. Since these devices are of a new kind, the manufacturer/importer needs to have enough evidence to support that medical device is safe to use, have better quality, and are efficient.
Conclusion – The Indian government is taking the rules and regulations related to medical device very seriously, especially if the device is new and do not have any predicate device. Thus, the manufacturer/ importers of new devices should thoroughly review the regulations and collect the documents mentioned. Because in case of any missing documents or half-submitted documents, the application will get rejected and thus will cause a delay in obtaining permission to market the devices.
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