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Quality Management System : Changing Scenario & Challenges In Medical Device Regulations

Mr. Sanjay Shah
Owner Promoter
Unikal Consultants, Ahmedabad

The impact of changing world scenerio vis-à-vis consumer awareness & requirement as also advancement in medical science is substantial but not significant as far as medical device industry is concerned especially in Indian context.

Reasons are many but mainly due to lack of appropriate regulations and consumer enlightement.

As for manufacturers world over including India, basic of the requirement, drawing a simile to c-GMP, requirement is QMS (Quality Management System) as per ISO:13485.

Lot of change is happening the curent QMS.

It is important to know what is meant by Quality, various definations:

• In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. It is brought about by strict and consistent commitment to certain standards that achieve uniformity of a product in order to satisfy specific customer or user requirements.


• Quality of something can be determined by comparing a set of inherent characteristic with a set of requirements. If those inherent characteristics meet all requirements, high or excellent quality is achieved. If those characteristics do not meet all requirements, a low or poor level of quality is achieved.


• According to this definition, quality is a relative concept. By linking quality to requirements,ISO 9000 argues that the quality of something cannot be established in a vacuum.Quality is always relative to a set of requirements. Quality is therefore a question of degree, as a result, ISO 8402-1986 standard defines quality as ”the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs”.


So what is QMS:


QMS is collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.


What is the basis for current trend in changes in regulations of Medical Devices?


EU Directive says,


Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive.


This means world is moving towards Risk based regulations. What is the risk involved in using the Medical Device, how to mitigate or reduce the risk to the user. Since this is continuous process, changing with enhancement of knowledge and technology, regulatory requirements is also a dynamic process. It keeps on changing with time.


In India scenerio, there is still no special Act for medical devices. It is covered under Drugs & Cosmetics Act & Rules and defined as drug. Also the medical devices included in the Act are very few and included by specific name and NOT by genral Harmonized defination of Medical Device.


So almost un-regulated it is in the hands of either non qualified & unregulated manufacturers or foreign manufacturers from whom they are imported.


Neither there is found need or encouragement to manufacture in India, medical device industry is in the nascent stage. Except in a few cases of low cost devices like IV Sets, Syringes etc. or manufactured by struggling but enterprising Indian companies producing Intra Ocular Lensees or coronary stents, rest of them ranging from catheters to MRI Scanning machines are imported.


What are changes in medical device QMS based on ISO 13485?


Following are excerpts from various sources:


The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.


The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and post-market surveillance requirements.


Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition to the new standard.


According to a draft transition planning guidance, organizations will still be able to be accredited for either ISO 13485:2003 or ISO 13485:2016 for the first two
years of the transition period; however, after the second year, new accreditation will only be given for ISO 13485:2016.


After the third year, the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”




Many organizations involved with medical device development, including manufacturers and service providers use ISO 13485 to “demonstrate [their] ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”


Regulators worldwide have integrated ISO 13485 into their regulatory systems, including those in the US, EU, Canada, Australia and Japan. The standard is sometimes adapted to meet local requirements, for example, EN ISO 13485:2012 in the EU adds a forward and several annexes to the standard specific to the region.


ISO 13485 is also used for the Medical Device Single Audit Program (MDSAP), an international effort to reduce redundant audits of medical device manufacturers.


“Many jurisdictions have got quality management system requirements for medical device manufacture and supply, so it’s really important that there’s a common
understanding between the regulator and the industry as to what’s required for that quality management system,” said Eamonn Hoxey, former chair of ISO’s technical committee for quality management and corresponding general aspects for medical devices in a video interview on ISO’s website.


What are ISO 13485:2016 Major Revisions ?


The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new international regulatory changes, implemented since its previous revision in 2003.


ISO representative Maria Lazarte, relayed a list of major changes from the technical committee for ISO 13485.


Some of the biggest changes between the 2003 and 2016 version include:

  • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements;

  • Increased linkage with regulatory requirements, particularly for regulatory documentation;

  • Application to organizations throughout the lifecycle and supply chain for medical devices;

  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard;

  • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties;

  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records;

  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and

  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay.

“it’s important to bear in mind that ISO 13485 does deal with the whole lifecycle from design and development, through manufacture, transport … and on to the end of  life.”


Quote from Mr. Hoxey.


The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system..

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