Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles -20 November 2023 (1430 onwards)
BIS, the National Standards Body of India was established for harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways, i.e., providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties, etc.
The Textiles Department, Bureau of Indian Standards is organizing an “Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles” on Monday, 20 November, 2023 at 1430 hrs onwards.
The main objective of the webinar is to spread awareness on product standards on Medical Textiles e.g. Sanitary Pad (Disposable and reusable), Baby Diaper, Bedsheet and Pillow Cover, Shoe Covers, Dental Bib, Coveralls, Facemask etc.
Webinar will not only talk about the salient features and importance of these standards but also disseminate valuable information on BIS conformity assessment/certification process for implementation of standards.
Through this webinar, it is envisaged to bring the manufacturers/stakeholders of Medical Textiles and BIS to a common platform for discussion on standards which are brought under Quality Control Order(QCO’s) by Ministry of Textiles (MoT) as well as its implementation related issues.
Considering the importance of the event we hope that you would make it convenient to participate in the above webinar. It is requested to confirm your participation by return e-mail.
Please note that there is NO REGISTRATION FEE for this webinar. You can join directly from the following link :-
Medical Device Regulations – Materiovigilance Program of India – News Letter from IPC
News Letter from IPC on Materiovigilance Program is shared below for information.
Since Medical Devices are brought under Full Regulations in the country, one of the mandatory Regulatory Requirement is Market Surveillance by Regulator .
Read the news letter shared below for more information
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
DoP releases strategy document to fine tune & implement National Medical Devices Policy
In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.
It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.
The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.
As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.
“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”
Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products
Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.
Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.
Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters
The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.
A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits
Holding the certificate can also help exporters in availing benefits with respect to customs and excise.
These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.
The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.
BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)
According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.
Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled
BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023
This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.
Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.
Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing
Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust
Who should attend?
Pharmaceutical manufacturers
Regulators
Government policy makers
Trade associations
Contract manufacturers
Hospital / healthcare systems sustainability procurement
Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing
Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments
Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.
The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments
In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :
Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
Manufacturing License of the product for Export purpose
Export Order
Representative sample from the export consignment
Thrice the quantity required for performing complete analysis of the sample
Qualitative composition of product including excipients
Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
Reference / Working standard (with traceability certificate) and placebo as applicable
Healthcare Textiles Processing Facility Certification Scheme Launched in India
On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse
While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.
The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).
Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.
The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.
The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.
