Medical Plastic Data Service Magazine



Our 30th Year of Publication
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Global Market


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

We are starting this column on regulatory processes for medical devices across the countries of the world in Medical Plastics Data Services magazine. The focus will not only be Regulations across the world but also on the export market for the Medical Devices and suggestive models for these markets.

Rapidly Changing Regulatory Scenario And Its Roll For The Health Care Products

Key words : Regulations – Necessity – WHO – Health policy – pace of changes – complexities just starting

Necessity of regulatory laws

Ensuring safety and efficacy for the health related products is important not only for the patients and medical professionals but even for the Government and the policy makers. Regulatory framework or Regulatory laws serve this purpose, making them essential. In the case of medical devices, actual users, namely medical professionals (doctors as well as paramedical staff) and patients do not know much about the quality aspects of these products. That role, therefore, falls on the authorities. Regulatory laws have an important role in conforming quality and safety of products being used.



In 2014, a fairly acceptable definition for the regulations was given. Regulations have been defined as the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information.


As the definition clearly mentions (accuracy of product information), regulations are important even for the product usage information, including labelling instructions. Simple parameters like manufacturing date and shelf life as well as storage conditions are supposed to be part of the product regulations.


WHO expanded regulatory role


.The role of regulatory field was later expanded by WHO where, in its handbook, WHO specified that even for the policymakers, regulations are important. Regulations represent a key means by which a government gives effect to its health policy preferences, especially through the exercise of a government’s law-making powers.


Changes and the challenge


It would be right to consider pharmaceuticals as the benchmark for this complex and ever-changing regulatory framework. Complex regulatory scenario for pharmaceuticals came into existence in the early 90’s. Regulatory complexities, thus, are not many years old. Before this period, regulations for medicines were very superficial and “mild”. Today, they represent a very complex process involving a huge set of data requirement, large cost impact and a very long time for approvals (even up to three years). All these changes in medicines have happened mostly in the last twenty years. Country-specific requirements also have a wide variation now, making the process more complex. Medical devices are at the initial phase of this process. Definitely, a very complex story is going to unfold in next few years. Those who prepare for this complex future today would be the front runners, and those who miss the bus may suffer as laggards. We, readers of Medical Plastics Data Services, always believe in seeing the future coming and preparing for that future today, and thereby stay ahead of others.


Regulatory complexities for Medical Devices in the countries of the world run across a continuum with two extremes. There are many countries today which have practically no regulations for the devices, and allow free import. In some countries, on the other side, a very complex process Including even the manufacturing plant documentation is needed.

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