Health Canada announced that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada. Later this month, Health Canada says it will provide manufacturers with a list of their …

Health Canada to Transition to Global Medical Device NomenclatureRead More »

In Singapore, medical devices are regulated by Medical Device Branch of the Health Sciences Authority (HSA) under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.   Singapore medical device registration& Scope of Regulation  Health Sciences Authority (HSA) requires companies to obtain a dealer’s licence before manufacturing, importing or supplying medical devices …

Singapore Medical Device Registration – HSA ApprovalRead More »

Medical device rules The Indian healthcare industry has been growing at double-digit rates and has evolved significantly in the last decade. However, a number of challenges need to be addressed in providing access to quality, affordable healthcare in the country. The new medical device rules which came into force from January 2018 has finally given the medical devices and in-vitro …

Indian Healthcare Scenario All Set To Change – Medical Device RulesRead More »

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify Blood Establishment Computer Software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). This rule is effective June 18, 2018. FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance …

Regulatory Controls Over Software Used in Blood Establishment | FDARead More »

As required by the Food and Drug Administration Reauthorization Act (FDARA), the FDA has issued a report on the continued quality, safety and effectiveness of medical devices related to servicing medical devices. As industry associations call on Food and Drug Administration (FDA) to increase regulatory oversight on the servicing of medical devices, a lack of evidence to …

FDA Publishes FDARA Mandated Report on Servicing of Medical DevicesRead More »

Medtec China, the leading medical device design and manufacturing exhibition in China, will take place on 26-28 September 2018 in Shanghai. More than 400 exhibitors will showcase their latest offerings at Medtec China 2018, and more than 10,000 decision makers, purchasing staff, R&D engineers, product engineers and quality inspectors from medical device manufacturers will congregate …

Medtec China 2018 Opens for RegistrationRead More »

The quality standards of medical devices consist of many aspects such as design control, risk management, vendor management etc. In this blog, we are going to discuss the importance of risk management ISO 14971 for medical devices and steps to implement it during the product development stage. ISO 14971 an international standard for risk management related …

Risk management system for medical devices | ISO 14971Read More »

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically. Brazilian medical …

ANVISA Changes for Low-risk Medical Devices | Brazilian MarketRead More »

The Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and facilities that offer the Essure permanent contraception device to provide specific information to patients about the risks and benefits of the device. This was not the first …

FDA announced on Approved Medical Device | FDA risk informationRead More »