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05Feb 2024

Updates in ANVISA GMP 2022 document

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...

05Feb 2024

EU, FDA, General Information, Regulations, Swiss, USA admin Comments: 0

Nomenclature of Medical Devices

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...

05Feb 2024

EU, Regulations admin Comments: 0

EU MDR – Article 117

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...

05Feb 2024

EU, Regulations admin Comments: 0

Quality Management System Requirements of EU MDR

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...

05Feb 2024

EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

Global ISO Requirements

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...

05Feb 2024

EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...

05Feb 2024

CDSCO, India, Regulations admin Comments: 0

CDSCO Registration Process

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...

05Feb 2024

Regulations, Blogs, Swiss admin Comments: 0

Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take action to remove or limit the risk of the recognised dangers. If a medical device malfunctions in Switzerland, the manufacturer is required to undertake an FSCA and Swissmedic keeps track of all FSCAs regarding medical equipment sold in...

05Feb 2024

Authorised Representatives admin Comments: 0

Switzerland Authorised Representative

Medical devices are regulated by the Swiss Agency for Therapeutic Product Manufacturer Responsibility 1.Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance. 2.Affixing the conformity mark and carrying out clinical evaluation according to Article 61 EU MDR. 3.Keep technical documentation, declaration of conformity & any other certificates updated. 4.At the request of a competent authority, the manufacturer should submit...

05Feb 2024

Authorised Representatives admin Comments: 0

Swiss Regulation QA WHITE PAPER

MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2. Which current Switzerland medical device regulations need to be followed by stakeholders? From May 26th, 2021, Stakeholders need to follow the revised Medical Devices Ordinance. (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-Medd). 3. What is the EU- Switzerland mutual rec...

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