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Association of Indian Medical Device Industry

29-31 July 2022
Chennai, India

28th International Exhibition and Conference
Pragati Maidan,
New Delhi, India
27-29 April 2023

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September-October 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: September - October 2022

Cover Story

Sterilization Technologies For Medical Plastic Products And Devices

All materials used in medical devices, including the plastics used in them, are essential to be capable of being sterilized without loss of performance. The article includes : A comparative analysis for various sterilization methods and Radiation Stability of Various Plastics...

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Indian Medical Device Manufacturing Industry: Evolving Ecosystem

Mr. Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd. & Forum Coordinator, Association Of Indian Medical Device Industry (AiMeD)

Indian medical devices manufacturing Ecosystem is evolving for the better. A Parliamentary Committee on Health has made very useful and relevant recommendations for manufacturers of Medical Devices and related shareholders as analysed in details in the article along with various other important components of the ecosystem...

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E-beam Sterilization : A Unique Opportunity For Indian Medical Device Industry

V C Petwal, Radiation Processing In-charge, ARPF & Head, Radiation Processing Lab, Department of Atomic Energy, Govt. of India, Raja Ramanna Centre for Advanced Technology, Indore

In a free-wheeling interview to “Medical Plastics Data Service", apart from introducing the first e-beam sterilization facility in the country, the process of sterilization, Medical Devices that can be sterilized by this technique, its comparative advantages as well as how the Indian Medical Device Industry can take benefit from this facility...

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Plasma Technology

Disinfection and Sterilization Using Plasma Technology

The potential of plasma technology in medical and dental applications is extremely broad. Along with disinfection / sterilization of medical and dental devices, the technology could be used to treat beds, desks, and floors. Plasma technology may also have therapeutic potential...

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Global Market - Medical Device

International Market Exploration For Medical Devices

Mr. Amit Dave, M. Pharm, MBA, Former CEO - Brazil Operations/ Vice President Export - Zydus Cadila/Claris Lifesciences

The article highlights the commercial aspects of the international market - starting with the market selection (or country selection). The article explains the logical reasons about why one should choose and go for a market outside India rather than sticking to India market only...

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Global Trends

• Sterilization Services Market by Method

• Freudenberg Introduces Silicone Sanitary Ends For Bioprocessing

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AiMeD & REGULATORY UPDATES

• Medical Devices Industry Asks Govt To Define And Bring Clarity On Online Sale Of Devices In New Drugs Bill, 2022

• DoC Approves Setting Up Of Separate Export Promotion Council For Medical Devices

• DoP Invites Eligible Medical Devices Firms To Apply For Newly Formed Category B of PLI Scheme

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Industry News

• Plastic product maker TekniPlex rebrands The updated brand structure unites all business units under two divisions: Healthcare and Consumer Products

• MTaI Expects Record FDI Growth In MedTech Space In 2022

• Siemens Healthineers Ties Up With IISc, HCG, Narayana Health

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Corporate News

• Carclo receivesExport Excellence Award by (FKCCI).

• Ground-breaking ceremony for new manufacturing facility of Nu-Vu Conair Pvt. Ltd.

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Event

• Medical Fair India Applauds The Formation Of The Medical Devices Export Promotion Council

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Product Gallery

• Class VI Tubing Portfolio for Single-Use Medical Device and Bioprocess Applications

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Did You Know?

About Importance of ISO 13485 for Medical Plastic Materials & Components Suppliers

Regulatory requirements demand making sure that Medical Device Manufacturers take responsibility for every supply-chain link to meet Good Manufacturing Practices.

Medical Polymers and Components: Quality Requirements

Plastics Materials & Components used for medical applications need consistent performance, including resistance to sterilization, chemicals and lipids. They often must also meet standards for biocompatibility and toxicity, where even slight changes in the ingredients in the plastics used could affect the acceptability of the finished device. Regulatory authorities require that the plastics are “well-characterized” with detailed information on the material ingredients and formulation, manufacturing processes, and extensive supporting data with respect to physical and mechanical properties, biocompatibility and toxicity.

Any material or formulation change over the lifetime of the product, and at any point in a sometimes highly complex supply chain, can invalidate previous approvals.

Importance of ISO 13485

This is why ISO 13485 certification is becoming more and more important. ISO 13485-2016 is the standard governing organizations involved in the design, production, and installation and servicing of medical devices. If upstream suppliers, like plastics processors, are also certified to the standard, they provide their customers with the assurance that they have invested in and understand the medical-device risk-management principles that are core to the standard. Also, that quality control and testing procedures have been applied to the raw materials they use in the components they provide and that they have the documentation to prove it.

Materials & Components suppliers should have a thorough understanding of the end-use application requirements, medical-device regulations that OEMs must meet, risk-management practices, and they will have put change-control measures in place. Usually this involves enhanced GMP and probably certification to an advanced quality standard such as ISO 13485-2016.

Colorants and additives must also be just as tightly controlled as the polymer. They are often subject to frequent changes, both major and minor ingredients such as pigments, stabilizers, plasticizers, lubricants etc. Careful sourcing procedures at each level of the supply chain are increasingly necessary to ensure that materials come with the necessary assurances, and that controls are in place.

The regulatory compliance and quality of a medical device is only as good as its weakest link.

In medical plastics processing, it’s all about minimizing risk.

Suppliers need to make sure there’s no chance a patient might have an adverse experience caused by some defect or oversight. Therefore, the companies supplying materials / components need to be vigilant to make sure actions they take don’t compromise the performance or safety of the final product..

( https://www.ptonline.com/blog/post/processing-medical-plastics-heres-how-to-minimize-risk )

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