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

Heal in India

Heal in India – Govt plans interpreters, special desks at 10 airports for ease of overseas patients

‘Heal in India’ – Government is likely to announce the initiative on August 15 2022.

The ‘Heal in India’ initiative aims to positioning the country as a global hub for medical and wellness tourism.

Interpreters and special desks at 10 airports, a multi-lingual portal and simplified visa norms are going to be the highlights of the government’s ‘Heal in India’ initiative to boost medical tourism.

The government has identified 44 countries, predominantly African, Latin American, SAARC and Gulf countries from where a large number of people visit India for medical purposes. The 10 identified airports — Delhi, Mumbai, Chennai, Bengaluru, Kolkata, Visakhapatnam, Kochi, Ahmedabad, Hyderabad and Guwahati — see higher footfalls of patients from these 44 countries

The Health Ministry, in collaboration with the National Health Authority, has developed a multi-lingual portal which would be a one-stop shop for services provided by medical travel facilitators and hospitals with an interface for foreign patients. The portal is also likely to be launched on August 15.

The portal will display standardized package rates based on the classification of hospitals and different systems of medicines including modern and traditional systems. It will also have a grievance redressal section as well as an option to submit patient feedback.

There will also be a mechanism to track patient journey by creating a unique health ID under the Ayushman Bharat Digital Mission framework and monitor service delivery in identified health facilities in India

Source:https://m.timesofindia.com/business/india-business/heal-in-india-govt-plans-interpreters-special-desks-at-10-airports-for-ease-of-overseas-patients/articleshow/93408941.cms

NHA Joins hands with QCI to Accredit ABDM Compliant Healthcare Solutions

National Health Authority (NHA) joins hands with Quality Council of India (QCI) to accredit ABDM compliant healthcare solutions like HMIS/LMIS

The National Health Authority (NHA) has onboarded the Quality Council of India (QCI) for six months to accredit and rate HMIS (Health Management Information System)/ LMIS (Laboratory Information Management System) solutions that have integrated with Ayushman Bharat Digital Mission (ABDM).

NABH will undertake the responsibility of accrediting and rating the ABDM compliant solutions on various parameters, including ease of usage, user interface, pricing, number of modules/features and value for money/pricing so that prospective purchasers may get credible information.

The purpose of this initiative is to encourage innovations by streamlining delivery of health tech services in a significant way. To develop a framework to ensure that ABDM compliant digital healthcare solutions are accredited and rated and to adequate information is available to consumers for choosing one solution over another.

Accredited health tech solutions will help healthcare organizations manage their patient journeys and business more methodically in accordance with ABDM standards. And ultimately, this initiative will help the citizens of India get better and more timely healthcare and help India become one of the leaders in digitization of healthcare in the world”

This accreditation exercise will be conducted in a phased manner. Phase I shall focus on accreditation and rating of HMIS solutions successfully integrated with ABDM. Subsequent phases shall include other subjective parameters and other categories of healthcare solutions like LMIS, Health Lockers, Health Tech,PHR (Personal Health Records) apps etc.

Source : Posted On: 04 AUG 2022 6:12PM by PIB Delhi

Regulatory Updates for IVDMD

Recent Regulatory Updates from CDSCO for IVD Medical Devices in India

Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.

In a review meeting held last week, Union Health Minister Mansukh Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.

He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action

The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness.

A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year,  while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

IVDs are also Medical Devices and are subject to the same regulatory framework.

In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc5Mw==

PCR Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mg==

Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mw==

Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software – 2022-May-05

Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit – 2022-May-05

Classification in IVD medical devices under the provision of MD Rules 2017 -2021-Jul-23

Source – https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/

CDSCO Notification

Central Drugs Standard Control Organisation – Notification dated 11th July 2022

In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class A & Class B categories are scheduled to enter licensing regime with effect from 01.10.2022

The Manufacturers are required to register their products on the portal (https://cdscomdonline.gov.in/NewMedDev/Homepage#) established for the purpose by CDSCO and to affix the registration number on the label of such registered medical devices.

All manufacturers are advised to apply for obtaining manufacturing license for Class A & Class B medical devices through CDSCO’s on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay.

CDSCO has also clarified that the quality certificates issued by any other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All manufacturers shall have to comply with the licensing requirement and obtain the license as per MDR, 2017, as the said rules do not recognize any such certificates which are not mentioned in it or part of it.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3MA==

Food Safety and Standards Regulations, 2022

Food Safety and Standards Regulations, 2022 – Notification – 34456/2022/REGULATION-FSSAI

FSSAI has issued a Notification (34456/2022/REGULATION-FSSAI) containing draft of certain regulations which the Food Safety and Standards Authority of India proposes to make in super session of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

Articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.

Categories covered under these regulations include: (a) Health Supplements (HS) (b) Nutraceuticals (Nutra) (c) Food for Special Dietary Use (FSDU) (d) Food for Special Medical Purpose(FSMP) (e) Prebiotic food and Probiotic food (Pre-Pro)

The draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation@fssai.gov.in

Source link: https://www.fssai.gov.in/upload/uploadfiles/files/Draft_Notification_Health_29_06_2022.pdf

Advisory from National Medical Commission

Advisory from National Medical Commission ( Administration Section )

National Medical Commission has issued an advisory note on 27th July 2022 to all Medical Colleges and Institutions to install cameras in their Institute premises at prescribed locations with the suggested specifications given in the advisory note.

Source link: https://www.nmc.org.in/MCIRest/open/getDocumentpath=/Documents/Public/Portal/LatestNews/20220727062249.pdf

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: