Last Updated on January 2, 2024 by The Health Master
The Drugs Technical Advisory Board (DTAB) has ratified the ministry of health and family welfare’s rule amending the medical devices rules to remove the specific deadline for the manufacturers and traders to implement unique device identification, leaving the decision to the central government to decide on when to start mandating it.
The DTAB, in its latest meeting, deliberated on the Ministry’s amendment to Rule 46 of Medical Devices Rules, 2017, through a notification at the end of December 2021.
“The Board ratified the amendments to the Medical Devices Rules, 2017 made vide GSR 918(E) dated December 13, 2021,” according to the meeting minutes.
Through the amendment, Rule 46 was substituted to read, “With effect from the date as may be specified by the Central government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be determined.”
Prior to this, the Center required that all medical devices that were approved for manufacture, sale, distribution, or import bear a unique device identification that contained both a device identifier and a production identifier. This was stated in Rule 46 of the Medical Devices Rules.
For the purposes of the rule, a production identifier is a serial number, lot or batch number, software as a medical device version, manufacturing date, and expiration date. A device identifier is a global trade item number.
It may be noted that through the amendment, the government decided not to fix any date of implementation of the UDI and also skipped the implementation of production identifiers.
A UDI is anticipated to increase patient safety globally by serving as a source for the identification of medical devices during distribution and use and by aiding in the quick resolution of issues by identifying the device in the event of an adverse event.
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It is also expected to reduce medical errors by integrating the information on the device which is used, into the medical records of the patients, according to experts.
It would be of better benefit if the stakeholders use a globally harmonized UDI system.
The United States Food and Drug Administration (USFDA) has established the UDI system to adequately identify medical devices sold in the US from manufacturing through distribution to patient use.
It has also established a Global Unique Device Identification Database (GUDID) administered by the FDA that will serve as a reference catalog for every device with a Unique Device Identifier.
It contains only the device identifier portion of the UDI, which serves as the key to obtaining device information in the database.
While it does not include the product identifiers (PI), the database contains PI flags to indicate which PI attributes are in the UDI, says the regulator.
The USFDA’s system makes the information searchable, to access details such as the device identifier on the label, device name, company name, safety status, and pre-market submission numbers, making them accessible to stakeholders including patients, caregivers, healthcare providers, hospitals, and the industry.
The DTAB, during the meeting, also ratified the Ministry’s amendment of the Medical Devices Rules, 2017, to provide registration numbers to the applicants who submitted applications for ISO 13485 certificates before February 28, 2022, till May 31, 2022.
The amendment added that if the applicant does not obtain the certificate before May 31, the provisional registration shall be deemed to have been canceled for all purposes without any notice.
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