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March-April 2022

30th Year of Publication 

A Techno-Economic News Magazine For Medical Plastics, Medical Devices, Diagnostics And Pharma Industry

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Content Overview: March - April 2022

Cover Story

Importance of Physician Contribution to the Development of Medical Devices

To promote innovation and entrepreneurship at Medical, Dental, Para-Medical Institutes and allied Biomedical Research and Academic Institutions, ICMR and (DHR), has brought out National Policy Guidelines on Biomedical Innovation and Entrepreneurship...

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Innovation & Development In Medical Plastics/ Devices & Pharma Packaging

Mr. Kishore Khanna, Managing Director, Romsons Group Private Limited & Jt. Forum Coordinator, AiMeD

Medical polymers are an essential part of the modern healthcare system. The article highlights important innovations and developments in medical polymers, their applications and processing...

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Quality

Importance of Biocompatibility for Medical Polymers and Regulatory requirements

Dr. K. R. Navaneethakrishnan, MSc, ERT, Assistant Director, GLR Laboratories Pvt. Ltd.

Biocompatibility can be defined as the relationship between a material and the organism so that neither produces undesirable effects. Biological evaluation of medical devices is a mandatory regulatory documentation for medical device registrations...

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A Risk-Based Framework for Biocompatibility Assessment

The risk-based approach adds the harm resulting from regulatory non-compliance and bureaucracy. It is about weighing the likelihood and the consequence of the identified risks and adapting the expenditure of resources accordingly...

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Understanding Who Certify For ISO 13485

Anil Jauhri, Ex CEO, NABCB

The certificate should be from a CB accredited by NABCB or any IAF member AB like IAS (USA) or EGAC (Egypt) or JASANZ (Australia) or KAB (South Korea) or...

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Global Market : Medical Device

Rapidly changing regulatory scenario and its roll for the health care products

Mr. Amit Dave, M. Pharm, MBA, Former CEO – Brazil operations Zydus Cadila, Former Vice President Export - Zydus Wellness and Claris Lifesciences Ltd.,

Regulatory complexities for Medical Devices in the countries of the world run across a continuum with two extremes. This column will not only be regulations across the world but also on the export market for the Medical Devices...

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Global Trends

• About Biocompatible Fabric - The Future Of Medical Textiles?

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Event Report

• Seminar On Innovations And Developments In Medical Plastics/Devices & Pharma Packaging

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AiMeD & Regulatory Updates

• Need To Standardise Methodology To Evaluate Medical Devices: NITI Aayog Member V K Paul

• DoP Releases Approach Paper To National Medical Device Policy To Make India “Diagnostic Capital Of The World”

• DoP Releases Draft Uniform Code For Medical Devices Marketing Practices

• Govt Amends Rules To Allow Import License For Devices With Certificate Of Sale From UK, Without Clinical Investigation

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Industry News

• Himachal Pradesh: Rs 810 Crore MoU Signed For Medical Devices Park At Nalagarh

• S3V Vascular To Invest Rs. 250 Crore For Setting Up Medical Devices Manufacturing Unit In Hyderabad

• US-Based Medical Devices Firm Confluent To Set Up Manufacturing Pilot Unit In Hyderabad Soon

• SMT Opens Asia’s Largest Stent Manufacturing Facility In Hyderabad

• Solvay, MCAM Partner To Recycle End-of-Life Plastic Medical Parts

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Product Gallery

• New Line Of Luer Lock Connectors To Address Nylon Shortage

• Calcium Zinc Stabilizer

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Events

• Medical Fair India : May 20-22, 2022, Jio World Convention Centre, Mumbai, India

• Medicall : July 29-31, 2022, Chennai Trade Centre, Chennai, India

• Medicall : September 17-19, 2022, New Delhi

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Did You Know?

About Important Thermoplastics Used in the Healthcare Industry

While polymers have been used in the healthcare industry for decades, more recently industry leaders are embracing the benefits of using specialty compounds and thermoplastics in medical, biomedical, and pharmaceutical applications. Beyond single-use plastics, higher performance polymers, medical-grade plastics, and thermoplastics present long-term value to patients and to healthcare as a whole.

Following are the six most readily used materials.

Ultra-High Molecular Weight Polyethylene (UHMW-PE) is a medical-grade plastic with high-impact strength, good wear and abrasion resistance, excellent chemical resistance, and outstanding low temperature properties.

Polyether Ether Ketone (PEEK) is a unique engineering thermoplastic that also offers excellent chemical compatibility, low susceptibility to stress cracking, clinically proven biocompatibility, high dimensional stability, and good electrical insulation.

Acrylic, the common name for polymethyl methacrylate (PMMA), is a medical-grade thermoplastic used in the manufacture of medical devices and medical implants such as intraocular lens implants, bone cement, and cranial implants.

Acetal Copolymer (Polyoxymethylene) is a medical-grade thermoplastic with high mechanical strength, rigidity, and dimensional stability. It delivers good sliding characteristics and excellent wear resistance, as well as low moisture absorption.

Polypropylene (PP) is a thermoplastic manufactured by the catalytic polymerization of propene. PPs are universal standard medical-grade plastics with well-balanced properties providing excellent chemical resistance, high purity, low water absorption, and good electrical insulating properties.

Polyphenylene Sulfide (PPS) is a high-temperature thermoplastic polymer that is very chemically resistant with amazing mechanical strength, even at temperatures above 200°C (392°F), with low susceptibility to creep.

( https://www.cdiproducts.com/blog/the-top-6-thermoplastics-trusted-in-thehealthcare-industry )

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