Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0

Hospital Accreditation Program

New Accreditation for Private Hospitals offering Maternity Services

To help mother-to-be choose private hospitals which lays emphasis on supporting her choice to breastfeed her baby, a new initiative has been launched for accreditation of private hospitals offering maternity services.

Under this initiative, Breastfeeding Promotion Network of India, a 30-year-old organisation, for protection promotion and support of Breastfeeding in India, and Association of Healthcare Providers of India (AHPI), comprising 12,000 private hospital including maternity centres, has entered into a strategic partnership and launched ‘National Accreditation Centre for Breastfeeding Friendly Hospitals’.

Source :

https://www.newindianexpress.com/cities/chennai/2021/dec/18/new-accreditation-for-pvt-hosps-offering-maternity-services-2396809.html

Upcoming Training Programs

Upcoming Training Programs Calendar from QCI TCB Division

Programs Calendar Announcement from QCI TCB Division

Greetings from The Quality Council of India (QCI)! 

With pleasure, Training and Capacity Building (TCB) Cell, QCI informs that we have received an overwhelming response for our virtual training/courses scheduled in this quarter. As we have received registration in an abundance for the month of November 2021 thus, we had to close a few of our courses due to the limited availability of seats. Appreciating the response, we have decided to announce new batches of virtual training in December, January & February. Please check the list below- 

Requirements of ISO/IEC 17065:2012 for Product Certification Bodies 29-30 Nov 2021 Registration   Open INR 5000 +GST 
Requirements of ISO/IEC 17020:2012 for Inspection Bodies  20-21 Dec 2021 Registration   Open INR 5000/-   + GST (18%)
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017$$ 25-26 Nov 2021  06-07 Dec 2021 Registration Closed INR 5000/-   + GST (18%)  
28-29 Dec 2021 Registration   Open 
ISO/IEC 17025:2017 – Risk Management requirements & implementation in Laboratories 15 Nov 2021 Registration Closed INR 2000/-   + GST (18%) 
22 Dec 2021 Registration   Open 
Uncertainty of Measurement and Decision Rule as per ISO/IEC 17025:2017 16-17 Nov 2021  22-23 Nov 2021 Registration Closed  INR 3500/-   +GST (18%)  
13-14 Dec 2021 Registration   Open  
Medical Laboratory System and Internal Audit program as per ISO 15189:2012$$  03-04 Mar 2022 Registration   Open INR 5000/-   +GST (18%)  
Lean Six Sigma Green Belt Certification 10-12 Feb 2022 Registration   Open INR 9500/-   +GST (18%)  

 

$ We also have eLearning modules for these courses, available at www.equest.co.in to raise your further competence. Once you complete both courses, you will get an additional ‘Competence Certificate’

The courses are designed for professionals like quality & senior management professionals from Inspection Bodies, Laboratories, Certification Bodies, Regulators, Government Bodies, Industry, PSUs, Consulting Organizations, Consultants, Training Organizations, Trainers etc. 

As we do not compromise on quality, we believe keeping a limited number of participants for the training courses will give sufficient opportunities for you all to participate in discussions and clarify doubts. 

After the completion of the course, all the participants will be issued a certificate of participation. 

Grab this opportunity as registration is accepted on the one come one serve basis. 

For this summer, we have launched various other trainings in the general domain as well.  

Fundamentals of Digital Marketing  18 November’21 
Organizational Values, Ethics & Office/Work Place Etiquettes 4 December’21 

Register yourself at the earliest by clicking on the link- http://bit.ly/virtualequest 

On eQuest (www.equest.co.in )we have an array of courses on domains such as Environment, Laboratories, Quality, Agriculture, Healthcare, and Technology-related fields. 

We have recently launched a new course developed by NABL ‘Program for Potential / Accredited / Applicant Proficiency Testing Providers on ISO/IEC 17043:2010” – the program designed for PT Providers to know about standard ISO/IEC 17043:2010 “Conformity Assessment – General requirements for the proficiency testing”.  

For registration and payment related queries, please contact,  
Rohit Varshney, Associate, TCB, QCI, rohit.varshney@qcin.org, Ph- 9773500376 

For any other queries, please write to  
Alok Jain, Director TCB, QCI, ajain@nabl.qcin.org, Ph. 9811352698  
Ranvijay Bihari, Dy Director, TCB, QCI, ranvijay.nabet@qcin.org, Ph. 8800424788 

This information is shared here as information update and for the reference of the industry.

Medical Equipment Expo

India International Medical Equipment Expo – Invitation Dec 11th – Dec 13th 2021

Announcement from Andhra Pradesh Medtech Zone

Dr Jitendra Sharma, MD & CEO, AMTZ is inviting you to the IIME Expo, scheduled to happen from the 11-13th Dec 2021 , hosted at Kalam Convention Centre, Vizag, celebrating 3 years of completion of AMTZ.

A unique platform for Medical devices & Equipment manufacturers, Hospital Infrastructure and consumables to meet and network with the Medical Fraternity including Hospital Owners/Management, Consultants, Surgeons & Physicians, Speciality centres etc under one roof.

Exhibitor Product Profile

Profile of exhibit based on Sutures & Sealing Devices, Patient Monitoring Devices, 3D Printers, Machines / Systems, Medical Furniture, Surgical Equipment, Endoscopy Equipment, Dialysis Machines, Lab Equipment, Consumables, Uniforms/Garments, Autoclave, EtO, Drapes, Surgical Equipment, Endoscopy Equipment, Manikins, Gloves, Drug Delivery / Extraction disposables, X-ray, Ultrasound, Digital Imaging, Helicopters & Private Jets, EMS Technology Solutions.

The event will see dignitaries from the Government of India, champions of med-tech, business leaders and hospitals congregating to celebrate our collective success. 

Venue :
India International Medical Equipment Expo 2021
Sat, 11 Dec 2021 – Mon, 13 Dec 2021
Kalam Convention Center
Visakhapatnam, India

Kalam Convention CenterAMTZ Campus, Pragathi Maidan, Siddeswaram, Nadupuru Reserve Forest, Visakhapatnam, Andhra Pradesh 530032

Directions – https://maps.google.com/maps/dir//Kalam+Convention+Center+AMTZ+Campus,+Pragathi+Maidan+Siddeswaram,+Nadupuru+Reserve+Forest+Visakhapatnam,+Andhra+Pradesh+530032/@17.6297358,83.1590403,16z/data=!4m5!4m4!1m0!1m2!1m1!1s0x3a396d5bec015829:0xf36d219478d9473f

Looking forward to seeing you.

Book Your Booth Now : https://lnkd.in/gRAd8rBa

Downloads:

E- Brochure: https://lnkd.in/gZUE2v-H
Floor Lay-out: https://lnkd.in/g8WK3cZq
Branding Opportunities: https://lnkd.in/geXQqNbu

Contact Co-ordinate:

Mr Harish
Director- ICEXPO
+91 8977924225)

Organic Certifications

Organic Produce Certifications – European Commission’s decision to delist Five Certifications Bodies from India over high levels of ETO

ETO level higher than permissible limits – Reason for Delisting

The European Commission has decided to derecognise five certifying bodies (CBs) from giving clearance or ratifying exports of Indian organic products for their failure to meet the ethylene oxide (ETO) norms in consignments, particularly sesame (til/gingelly).

A draft of the European Union Committee on Organic Production (COP) on derecognising the five CBs or certifying agencies was issued in October for comments from various stakeholders. These comments were taken up last week before it took a final call.

With all the European Union (EU) members supporting the move, the COP decided to derecognise the five CBs – four from the EU and one from the US – on November 30.

The decision comes despite hectic lobbying by the EU, the US trade bodies and consultants against any action against the five. Instead, they sought action against the Agricultural and Processed Food Products Export Development Authority (APEDA).

The EU derecognised the five CBs, which certified over 80 per cent of the organic products exports to the EU, as they had certified some 90 shipments against which the EU Organic Farm Information System (OFIC) issued notifications for ETO level being excess than permitted level 0.1mg/kg.

The five CBs are ECOCERT India Pvt Ltd, CU Inspections Ltd, Indian Organic Certification Agency (Indocert), Lacon Quality Certifications Pvt Ltd – all based in EU – and the US-based OneCert International Private Ltd.

The blacklisting will come into force from January 1, 2022, and will be valid until APEDA removes them from the “high risk category” list they have been placed after being found at fault.

APEDA, which is the competent authority in India to supervise organic certification processes, has also suspended OneCert’s accreditation for one year, while ECOCERT, CU Inspections, IndoCert have been barred from registering any new processor or exporter.

In addition, APEDA has also asked Aditi Organic Certifications to not register any new processor or exporter. The five CBs have also been imposed ₹2-5 lakh penalties.

In its draft, the EU COP said, “Since October 2020, a large number of consignments totalling thousands of tonnes allegedly organic sesame seed contaminated with ethylene oxide have been imported from that third country, in particular from operators controlled by the control bodies supervised by India…”

ETO is considered carcinogenic for humans by the EU and a few other countries, and it is strictly monitored to ensure that shipment of any product conforms to the norms. In the case of India, the presence of the chemical exceeded far more than the permitted level, which the EU felt posed a health risk to its consumers.

The EU derecognition of the five agencies also means that their names should not appear in APEDA’s list of CBs recognised by it. The derecognition is unlikely to affect exports of organic products – as feared by the EU and US trade bodies – from India as there are 28 other CBs, Indian and foreign, that can fill in the void.

Source : https://newonnews.com/ec-ratifies-move-to-derecognise-five-agencies-certifying-organic-exports-from-india/

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe. Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Wellbeing is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure availability of Responsible Supply Chain as a Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe.

We, in India too are seeing a huge surge in exports as well as in imports of Products and Services and how do we ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

European Union is the largest market for Indian Exporters and businesses strive hard to create market space for their products and services. Earning and Retaining Customer Loyalty, Recognition and Reputation at market place is not an easy ride for any business. Its the reasonability and duty of industry bodies, industry associations to work in coordination with Regulators like APEDA and ensure that wrong trade practices by businesses, Certification Agencies should be questioned.

Regulators, Accreditation Bodies, Certification Agencies, Industry , Consultants are the key stakeholders to this process and all have to work in alignment , incordination to ensure that Responsible Supply Chains are made available for domestic as well as for global markets.

Issuance of Certifications is an Assurance to the market place that Products that are Certified for Quality are Safe for Consumption. When this process gets compromised, consumers faith and trust on Quality will erode.

Notification from NABH

NOTIFICATION FROM NABH – CGHS , ECHS EMPANELMENT

Announcement from NABH

NABH has released a notification about empanelment process for CGHS / ECHS by HCOs.

Start of NABH CGHS / ECHS Portal for acceptance of online applications for Central Government Health Scheme (CGHS) & Ex Servicemen Contributory Health Scheme ECHS

National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of Quality Council of India (QCI) is pleased to announce that the process of QCI inspections for ECHS & CGHS empanelment has now been digitised.

The Health care organisations will now be able to apply for and pay fee for empanelment through this online portal; guidelines for which are available on the NABH website at Steps to Apply for ECHS & CGHS Empanelment document.

Applicants desirous of getting their facilities assessed for CGHS / ECHS Empanelment are encouraged to apply online for prompt processing.

In case, the HCOs have any difficulty in applying, they may contact NABH Secretariat at E mail: nabh@nabh.co

Phone: 4260060

Download the notification and Step by Step Process to apply for the Empanelment Here

NABL Announcement

CLARIFICATION ON UNIQUE LABORATORY REPORT (ULR) NUMBER

Accredited testing laboratories, calibration laboratories and Reference Material Producers may note the clarification on the use of ULR number released by NABL recently.

Key Highlights about the announcement :

Government electronic Marketplace (GeM) accepts test reports issued by NABL accredited laboratories along with the products which are uploaded on the GeM portal.

Similarly for product / equipment which is to be used after calibration, the calibration certificates issued by NABL accredited calibration laboratories are accepted. RM document from NABL accredited RMP is required to be uploaded along with any (certified) reference material on GeM portal.

To authenticate the test reports / calibration certificates / RM documents, GeM has sought the co-operation of NABL in getting the data on reports mapped with the claim of the sellers. To facilitate such mapping, an 18-digit ULR number has to be mentioned on all reports issued by testing & calibration laboratories and RMPs. This number will be in addition to the report number of the laboratory / RMP and will have to be mentioned in all reports issued with accredited scope only.

This system is not mandatory for test reports issued by bulk petroleum product manufacturer’s laboratories, test reports of non-commodities like air, waste water and similar environmental parameters and results related to veterinary testing, dope testing & forensic testing.

For testing and calibration laboratories, discipline (example- Biological / Mechanical) and group (example- Water /

Dimension) as applicable needs to be mentioned before the product and parameters in the reports. (Please refer NABL 120)

For RMP, category and sub-category needs to be mentioned before the product / parameters in the document. (Please refer NABL 191).

It is reiterated that the ULR system has to be followed in line with the current version of NABL 133.

This system is not to be used in reports containing parameters outside the scope of NABL accreditation.

Read the full notification issued by NABL here :

Announcement

Announcement from NABL on CABs

Sharing the recent announcement from NABL on CABs.

There is a fast track focus at the market place to seek Certifications fast. This trend is more visible at the market place now. Fast tracking , resorting to various acts as listed in the announcement is not a healthy sign for the industry.

Certificates , Certifications are of no use, of no relevance when the users, payers, for the services don’t experience “the showcased Quality of Service”. There is a structure , methodology that needs to be followed while seeking Quality Systems Certifications.

The sudden rush for Certificates must be driving businesses to resort to unhealthy practices is what is understood from the notification !

Sharing this here to as information update for industry to take cognizance of the notification.

World Quality Month Programs

WORLD QUALITY MONTH – INDUSTRY CONNECT KNOWLEDGE SERIES – WEBINARS

Global focus on Product/Service Quality and Safety has undergone a dramatic change after the pandemic crisis across the globe.

Quality and Safety of Global Public Goods call for International Alignment of Standards, Certifications, Testing norms etc to ensure that Consumers Health, Safety and Well being is not compromised.

Responsible Production is the Global Call of Action and the it’s the Responsibility of the Global Markets to ensure Responsible Supply Chain as Consumer Welfare measure.  Global economy is moving towards Borderless Economy and many countries will have market access to global markets due to supply chain shortages. The countries which assure Authentic and Responsible Supply Chains will have strong acceptance across the globe. 

India too is seeing a huge surge in exports as well as in imports of Products and Services and how do to ensure that Consumers are assured of Quality and Safe Products and Services in domestic as well as in International Markets.

It is in this context that Consultants Consortium of Chennai (CCC) is rolling out series of Knowledge Sessions to Celebrate the November Month of Quality by connecting Industry and Stakeholders to various sessions which are the need of the hour programs.

CCC has scheduled 6 sessions spread , across the month of November, starting from November 11th 2021 till end of the month. Multiple sessions covering various sectors are scheduled.

CCC will keep communicating and inviting all stakeholders and industry to the sessions. Sessions will have the support of industry, academia, young entrepreneurs, innovators forums and various other stakeholder organizations.

This information is being shared to facilitate industry, academia, startups, Management Systems Consultants and various other stakeholders to register for the sessions . 

Sessions are conducted through Virtual Mode and there is NO REGISTRATION FEE.

SESSION 1 – NOVEMBER 11TH 2021, THURSDAY- 4 :00 PM – 5:30 PM

TOPIC – RESPONSIBLE QUALITY CERTIFICATIONS

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

SESSION 2 – NOVEMBER 13TH 2021, SATURDAY – 4 :00 PM – 5:30 PM

TOPIC – Accessing Global Markets – Role of Private Certifications in Food Sector

Delegate Registration Link :

Registered Delegates shall receive autogenerated registration link from Zoom id. Please check your spam folders too if you do not receive the mail in your in box.

For further assistance , email to – contact@ccc-consultants.org

WORLD QUALITY MONTH SERIES – SUPPORTING BY INDUSTRY ASSNS, CHAMBERS