The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
Medical devices that conform to regulations require a conformity marking. Exceptional use medical devices are those that do not comply with regulations of a particular country and do not require a conformity mark. These medical devices may not conform to applicable regulations, but they could still potentially protect patient health.
Smart wearables technology is gearing up to great potential and becoming a part of our daily lifestyle. While most of them are claimed to fall under general wellness equipment, there is a rising concern about how these devices are regulated in terms of safety without falling under the stringent medical device regulations.
The Indian Medical Device Rules regulatory have transformed to be more complicated over the years. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The main official body that is responsible for the approval of the manufacture, import, sale, and distribution of medical devices is the Drug & Cosmetic Act and Rules (DCA).
How can we assure that we receive truthful information about a product from the manufacturer? Are Manufacturers/Distributors always honest with their claims? Find out from this article.
Ever wondered in this world of difference, is there any common thread amongst different countries? The answer is International Organization for Standardization (ISO). To know more, check out the following article.
The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to comply with EU MDR 2017/745.
EU MDR’s Article 117, is a very short article, but with a great impact on the procedures for marketing medicinal products integrated with medical devices.
‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.
The Good manufacturing practices (GMP) document released on 30th March 2022 for Medical and IVD products replaced the GMP document released by ANVISA in 2013. In this article we will discuss the Significant changes that were made in the latest 2022 Regulations which supersedes the 2013 version.