NABH Announcements

Announcements from NABH – Fee Remittance Norms & Communication Matrix to be followed by all Applicant / Certified / Accredited Healthcare Organizations

Announcement 1 – Fee Remittance Notification

Kind Attention : All applicant / Accredited / Certified Health Care Organisations under all programs of NABH

In continuation to the previous notice of NABH related to fee payments  issued  on February 16, 2021, many Healthcare Organisations associated with NABH, are still making direct payment to Quality Council of India – NABH. NABH is facing d i f f i cu l t y in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.

To avoid unnecessary wastage of time  and  manpower  in  tracking  the  payments, NABH advises its stakeholders to  make payments  only through  the online portal  using the Payment Gateway  so that the payments  are appropriately  tracked  for  convenience  of all the parties.

In order to facilitate the Healthcare  Organisations  to reconcile  the fee payment  status,  NABH is requesting all the HCOs to follow the below steps with immediate effect:

  1. The HCOs a r e advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
  • HCOs are advised to refrain from depositing cash/cheque/DD directly into  any  account of Quality Council of India.
  • In case the HCO has no other option but Bank Transfer (NEFT/RTGS), it shall be responsibility of the HCO to update the transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction Amount, etc  on  the NABH Portal under the Make Payment category and inform NABH that the Payment was done and get the receipts generated for the payments made.
  • The HCOs are also requested to ensure that the payment details with respect to fee payments of current and previous accreditation cycles have been updated on the NABH portal account of the HCO, if not done earlier.

QCI-NABH plans to stop direct payments into its accounts done through DD/Cheque/Cash Deposit/Offline Bank Transfer (NEFT/RTGS) by March 31, 2022 and is seeking the cooperation from HCOs in this regards.

Download the notification from NABH here

Announcement 2 – Communication Matrix Released for the benefit of all Applicant / Certified / Accredited HCOs

NABH has earlier issued NABH communication matrix – NABH/Notification/Communication/2020/2049 dated 25th September 2020

All the applicant and accredited/ certified HCOs that are listed in the NABH portal have the provisions for making communications with the officials of NABH through “REMARKS COLUMN”. All HCOs are requested to utilise “REMARKS” for communicating/ raising queries regarding status of their applications for accreditation/ certification to ensure transparency as well as for records.

HCOs are also requested to refrain themselves from communicating through emails or telephonically. It is practically not possible to reply to each mail or phone call individually. Moreover, neither your communication nor reply from NABH is captured for the case record purpose.

In case, the queries of the HCOs submitted through remarks on the portal are not replied within three working days, emails to Program Heads may be sent, along with contents of email copied at on-line portal remark column. The list of all programs of NABH and the responsible Program Head with contact details are listed in the notification released by NABH.

Download the notification from NABH

Source :

CDSCO Fresh Notification

Regulation of CT scan equipment, All Implantable Devices, MRI equipment etc. as
Drugs with effect from April 1st, 2021
– Fresh Notification from CDSCO

Notification from CDSCO – Released on 3rd Nov 2021

Notification Highlights : CDSCO

Stakeholders have now represented their concerns that due to Covid-19 disruption there is unpreparedness in complying with regulatory requirements within the prescribed timelines, which may lead to disruption of supply chain & access to patients.

Therefore, in order to ensure smooth transition of manufacturers/importers, continuity of supply chain and access to the patients, with the approval of MoHFW, it has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of those devices, and whose application has been submitted to the Central License Authority or State License Authority, as the case may be, for grant of import/manufacturing license in respect of the said device(s) under provisions of MDR, 2017 by 18.04.2021, the said application shall be deemed to be valid and the importer/manufacturer, can continue to import/manufacture the said device(s) up to 30.06.2022 or till the time the Central License Authority or State License Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Further, the applicant, in case has submitted an incomplete application (submitted by or before 18.04.2021), is required to ensure submission of all the necessary documents to the concerned Authority, by 31.03.2022

Central Licensing Authority or State Licensing Authority, as the case may be, shall dispose of these applications within three months from the date of receipt of complete application.

Further, the importer/manufacturer of above said medical devices has to obtain import/manufacturing license for the above said devices by or before 30th June, 2022. The importer/Manufacturer shall necessarily be required to print the import/manufacturing license number on the label with effect from 1st of July 2022.