FAQ
Of course. To make your compliance journey easier, Tacit Medtek provides end-to-end assistance with documentation, regulatory submissions, and communication with CDSCO and other regulatory bodies.
Yes. The Medical Devices Rules of 2017 mandate that, depending on the device's risk class, all medical devices must have a license before being manufactured or imported.
No, ISO 13485:2016 is not required to obtain a manufacturing license under MDR-2017; nonetheless, it is highly advised because it complies with regulatory requirements.
Yes, it is not required to indicate a device's expiration date or shelf life if it is given in a non-sterile state.
Technical paperwork, clinical evaluation, conformance assessment, and adherence to EU MDR/IVDR are all part of CE marking. Startups can get help from Tacit Medtek during the whole CE certification procedure.
It is necessary for devices that interact with the human body directly or indirectly. ISO 10993 requirements must be followed when conducting tests, and they must be revalidated if materials or procedures change.
Yes, if the materials, processes, and suppliers are unchanged, and supported with justification and a biological risk assessment.
Yes. If you are a foreign manufacturer, you are required to designate an Indian Authorized Agent to manage communication and regulatory submissions.
No, a separate application, supporting documentation, and costs are needed for each actual manufacturing site.
If your company's constitution changes, you must notify the licensing authority and reapply for a license within the allotted time (usually 180 days).
A medical device that has undergone processing to eradicate all microbiological life and is packaged
to
remain sterile until it is opened or damaged is considered sterile. The device's sterility must be
explicitly stated on the label, along with the sterilizing technique that was
employed.
However, a
non-sterile medical device is one that is provided without being sterilized. The label of the devices
must
explicitly say that it is "non-sterile" and provide instructions for correctly sterilizing it before
use
if that is the plan.
No, Chapter XI of MDR-2017 exempts Class A non-sterile and non-measuring medical devices from wholesale licensing.
In addition to clearly stating that the equipment is non-sterile, the package must reduce microbiological contamination and contain instructions for sterilizing appropriate for the planned approach prior to patient use.
Yes. Any changes must be reported to the licensing authority within 45 days, and the licensee has 180 days from the date of the constitution change to submit an application under MDR-2017. In these cases, unless a new license is granted or the application is rejected by the licensing authority, the current license will be considered valid.
Yes. Within 45 days of the constitution change, the licensee has 180 days to file an application under MDR-2017, and any modifications must be communicated to the licensing authority. In these situations, the existing license will be deemed valid unless a new license is issued or the licensing body rejects the application.
In order to indicate that a medical device is sold freely in the countries of Australia, Canada, Japan, the European Union, the United Kingdom, or the United States of America, the Free Sale Certificate (FSC) granted to the legal manufacturer must include brand names (registered under the Trade Marks Act, 1999) for the device in Form MD-14. If the brand name is not listed in the FSC, it should be listed on Form MD-14 as "Not Applicable."