Regulations

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.   What is Good Manufacturing Practice (GMP)?  Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.  The GMP document released on 30th March 2022 for Medical and IVD produ...

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...

Quality Management Systems (QMS) are defined by the MDR as formalised systems that document processes, responsibilities, and procedures to ensure and continually improve the standard of company activities. To obtain CE marking and market devices in European Union, an effective Quality Management System that complies with EU MDR 2017/745 is must. Article 10 of EU MDR 2017/745 explains the general obligation of manufacturers to place their products in the EU market. A...

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...

This guidance is applicable to manufacturers placed within India. Get detailed information about CDSCO registration process. Regulation Medical Devices Rules, 2017 Important Forms License to manufacturer Notified Medical Devices License in Form MD-5 or 6 for Class A or Class B Application  formForm MD-3 or 4  for Class A or Class BRule 20 Rule 20(4) and 20(6) for Class A or Class B State Drug Licensing Authority License to manufacturer Notified Medical Devices License in Form MD-9...

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...