Summary :
-The ministry of health and family welfare has decided to extend the date of implementation of the unique device identification (UDI) of medical devices, which was to come into effect from January 1, 2022, till further orders.
Under the Rule 46 of the Medical Devices Rules, the Centre has earlier decided that “With effect from 1st day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.”
For the purpose of the rule, device identifier means a global trade item number and production identifier means a serial number, lot or batch number, software as a medical device version, manufacturing and expiration date.
In the proposed amendment, the government decided not to fix any date of implementation of the UDI and also skipped the implementation of production identifier.
Health ministry extends date of implementation of UDI for medical devices
In a draft amendment, notified by the Ministry on December 23, this rule is proposed to amend as “With effect from the date as may be specified by 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.”
The proposed amendment was published for information of all persons likely to be affected and issue notice to all concerned that the said draft rule shall be taken into consideration on or after the expiry of a period of five days from the date on which the copies of the Gazette of India containing the draft rule is made available to the public.
Objections and suggestions received within this period will be considered by the Central Government.
Globally, a UDI is expected to improve patient safety by a source for identification of medical devices through distribution and use and help to solve problems rapidly by identification of the device in case of an adverse event. It is also expected to reduce the 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 harmonised UDI system.
The United States Food and Drug Administration (FDA) 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 obtain 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 US FDA provides device labellers with two options for submitting the data to the GUDID, the manual data entry through a web application for entering data for one device at a time and another through the FDA Electronic Submissions Gateway for bulk uploads.
This information is searchable, to access details such as the device identifier on the label, device name, company name, safety status and pre market submission numbers, accessible to stakeholders including patients, care givers, healthcare providers, hospitals and industry.