Procedure to Get manufacturing/import license for new Medical Devices India

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:

• Those substances which are used in the in-vitro diagnosis and surgical dressings, bandages, staples, sutures, ligatures, blood, and blood components collection bag with or without anticoagulant covered under sub-clause (i).
• Substances including mechanical contraceptives (condoms, tubal rings), disinfectants, and insecticides under sub-clause (ii).
• Device notified from time to time under sub-clause (iv).

Manufacturing/Import License for New Medical Devices

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:

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.

Steps to apply for manufacturing/import license for new medical devices that do not have a predicate device:

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

• Identify the similar product
• The manufacturer/importer must check if the proposed device has the same technology, intended use, etc., with respect to the device they have taken as the predicate device.
• If there is no substantial equivalence between the predicate and the proposed device 

Step 4: Fill out the form MD-26

Step 5: Pay the fees challan

Step 6: Submit the documents

• Design analysis (whichever is appliable)
• Design input and output documents
• Mechanical, Electrical, and Reliability test
• Software validation relating to the function of the device
• Any performance tests
• Biocompatibility tests, reports of the tests with rationale for selecting these tests, a summary report of the biocompatibility test including study conclusion.
• Data on Risk-management
• Study data on animal performance study
• Data on Pilot or Pivot clinical investigation, including the data carried out in other countries
• The applicant should submit data supporting the claim if the clinical investigation waived off the device.
• Regulatory status, restrictions on use in other countries (if applicable)
• Proposed instructions for use and label

Step 7: The CDSCO will review the documents

Step 8: Discussion Meeting to work upon the application.

Step 9: there are two scenarios now

If the documents are okay, then the applicant will get permission to manufacturing/import license for new medical devices in form MD-27

• The permission holder of Form MD-27 shall submit a periodic safety report update report to the CLA from the date of launch in the market.
• Such reports shall be submitted every six months for two years, followed by annual submissions for the two years.
• The permission holder of form MD-27 shall submit the suspected unexpected serious adverse events within 15 days of the awareness of the event to the CLA.

If documents are not okay, the application for permission to import or manufacture new medical device will be rejected within 120 days, not exceeding 30 days from the date of application.

• It is the responsibility of the CLA; they shall share where the information is insufficient with respect to the requirements as per sub-rule (1) and shall inform the applicant in writing within 120 days, not exceeding more than 30 days, for reasons to be given in writing, the conditions shall be satisfied.
• The applicant will have 90 days to respond to the required information shared by the CLA from the date of initiation. If the applicant fails to give the justification within the given time or if CLA is not satisfied with the information provided by the applicant within the given time, then CLA has the right to reject the application.
• The applicant has the right to appeal against the decision given by the CLA to the central government, and the government, after the inquiry, as they consider necessary, can pass orders in relation within 60 days from the date of appeal.

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.