Taking a step further to strengthen the quality and standards of ‘Medical Devices’; Ministry of Health and Family Welfare (MoHFW) in consultation with the Drugs Technical Advisory Board (DTAB) has suggested an amendment to the Medical Devices Rules, 2017. A draft published in the Gazette notification dated December 23, 2021 suggested the amendment to Rules 46 of the Medical Devices Rules, 2017- for Rule 46, the following rule shall be substituted: “46. Unique device identification of the medical device — 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.” It has been notified that the said draft rules shall be taken into consideration on or after the expiry of a period of five days from the date on which copies of the Gazette of India containing these draft rules are made available to public.

 

The objections and suggestions were invited till December 28. Now, the MoHFW 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 January 1, 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. 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.