Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

NHA issues hardware guidelines for effective implementation of Ayushman Bharat Digital Mission

NHA issues hardware guidelines for healthcare institutions at State/ UT level to facilitate effective implementation of Ayushman Bharat Digital Mission

The National Health Authority (NHA) issued hardware guidelines across States and Union Territories for healthcare institutions like hospitals, clinics and health and wellness centres to promote digitization in hospitals.

The guidelines provide a basic framework to States/UTs for planning, assessment and procurement of the IT hardware (including IT specifications of various hardware equipment) to operate applications compliant with Ayushman Bharat Digital Mission (ABDM).

The guidelines on the IT hardware specifications to support this ecosystem is available at https://abdm.gov.in:8081/uploads/Hardware_Guidelines_ABDM_e162cf7a7b.pdf. The document will help the States/ UTs in assessing the hardware requirements while planning and procurement of IT assets for healthcare institutions of all scales.

The guidelines published by NHA is suggestive and recommendatory in nature. States/UTs and the health facilities have the flexibility to modify these guidelines based on local requirements and circumstances.

Source: Posted On: 22 AUG 2022 4:17PM by PIB Delhi
source link: https://pib.gov.in/PressReleseDetailm.aspx?PRID=1853603

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Health Facility Registry

Ayushman Bharat Digital MissionHealth Facility Registry

Health Facility Registry is a comprehensive repository of health facilities of the country across modern and traditional systems of medicine.  It includes both public and private health facilities including hospitals, clinics, diagnostic laboratories and imaging centers, pharmacies, etc.

Registration will enable health facilities to get connected to India’s digital health ecosystem and allow their listing on a national platform

Who can Register

• Hospital and Clinic
• Diagnostic Laboratory
• Imaging Centre
• Pharmacy
• Cathlab
• Dialysis Center
• Blood Bank
• Modern Medicine ( Allopathy)
• Unani
• Dentistry
• Siddha
• Physiotherapy
• Homeopathy
• Ayurvedha
• Sowa – Rigpa

Benefits of Registration

 Unique & Trustable Identity – Facility ID for identification of health facilities across the ABDM ecosystem
 Ease of doing business – Digitisation of services
 Online Presence & Discoverability – Listing of health facilities on a national platform
 Unified Digital Services – Access to telemedicine, digital health records and HMIS solutions

How to Register?

Login to https://facility.abdm.gov.in/#

• Sign Up as a Facility Manager – Create your Facility Manager ID i.e your Healthcare Professional ID linked to Aadhaar (Your aadhaar must be lined to your mobile number to create your Health ID)
• Select type of facility to view Registration process – Government / Private / PPP
• Search your Healthcare facility
• Fill Registration Form – Enter Facility details, services offered and infrastructure details
• Review and Submit Form for verification
• Verification by District Verifier

User manual for Registration:

Workshop on Patient Safety and Quality Improvement

Education/Interactive Workshop on Documentation Requirement for Patient Safety and Quality Improvement

NABH is organising a Workshop on Documentation Requirement for Patient Safety and Quality Improvement on Sunday, July 17, 2022 between 2 pm to 6 pm.

Like all quality management systems documentation is an essential component of NABH accreditation. NABH standard require various documentation. Documentation which provides correct, complete, current, and consistent information and also effectively meet customer and stakeholder’ requirements should exist in an organisation who is aspiring to implement quality standards.

Who should attend?

1. Medical and Nursing professionals 
2. AYUSH  professionals
3. Administrators
4. Healthcare Management Students
5. Quality Managers

Why one should attend?
1.This training will provide knowledge with which one can create required documents for his / her organisation. This workshop is also going to equip the participant with knowledge about system documentation and how to create hierarchy of policy then procedure and then Work instructions or Standard Operating Procedures (SOP). All documentation moves from one level to the next. The first tier of documentation is the policy. This is the document that defines what will be done and why. Policy needs to be clear, precise and practical, and easy to understand. The second tier of documentation is procedures. Procedures describe the methods that will be used to implement and perform the stated policies. Work instructions or Standard Operating Procedures (SOP) are usually department, machine, service, or task oriented and describe how a job will be done. The instructions are the most detailed of the documentation hierarchy.

2. What constitutes Good Documentation? How to

·  Approve, review and update documents.
·  Changes & current revision status of documents identified
·  Keep relevant versions of applicable documents available at points of use
·  Ensure that documents remain legible and readily identifiable
·  Ensure that documents of external origin identified and their distribution controlled
·  Prevent unintended use of obsolete documents, and archiving.

3. This training will strengthen the understanding of quality principles hence enabling well trained professional to become “Champions” in quality and to apply them to improve quality & work flow.

4. Trained Professionals will learn how quality can reduce errors and hence increase patient safety.

Course material and certificate for participants

Each workshop participant receives course contents including learning and reference material. The workshop will be a combination of theory, demos and panel discussions and will involve active participation.

At the successful completion of workshop candidates will be provided certificate of participation.

Workshop Fee:

The registration can be done by filling the registration format at our web-site (www.nabh.co/login). Registration fee (non-refundable & non-transferable) is Rs. 4,000/- + GST@18% (Total Rs. 4720/). Fees concession of 10% is being provided for the members of Quality Council of India (http://www.qcin.org/nbqp/PMS/).  

Limited seats are available only first come first serve basis. To ensure your participation through online registration.

Programme Date : 17th July, 2022
Programme Timings: 02.00 pm to 06.00 pm

For registration and any other related query please contact      

Mr. Vikash Chaudhary
Administrative Officer
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor, 4 – A, Ring Road, I P Estate,
New Delhi – 110002
Tel: +91 11 42600622 
Fax: +91 11 233 23 415
Email: vikash@nabh.co