New Update on Medical Device Testing Laboratory: As per the news released on November 23, 2022, four more medical device testing laboratories (MDTL) approved by CDSCO, to evaluate and carry out the testing of medical device on behalf of the manufacturers. So now the total number of MDTLs across the country is 28. The four new […]
Updated list of Certified Medical Device Testing Laboratory (MDTL) Read More »
MDUFA IV Changes The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance giving device makers an overview of the types of feedback and meetings they can request during pre-submission phase as part of the agency’s Q-submission program. The draft guidance is meant to update and replace the agency’s recently finalized Requests for
FDA Updates Guidance for MDUFA IV Changes Read More »
Radiological Imaging Devices The US Food and Drug Administration (FDA) on Monday announced a proposal to down-classify certain medical image analyzers from class III to class II. The proposed reclassification is part of ongoing efforts at FDA to strike an improved balance between pre- and postmarket data. Computer-assisted/aided (CADe) detection devices for mammography breast cancer,
CDRH Down-Classifies Some Radiological Imaging Devices Read More »
Australian Regulatory Guidelines Australian government’s Department of Health has approved a guidance for advertisers that applies to the current Therapeutic Goods Advertising Code 2015 but incorporates an amendment to the Therapeutic Goods Act 1989 (the Act) that came into effect on the 6 March 2018. The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government’s Department of
Australian Regulatory Guidelines for Advertising Therapeutic Goods Read More »
What is CAPA? To achieve greater quality in manufacturing you need to understand the essential elements of quality management, continuous improvement, and process discipline .ie. CAPA (Corrective action and preventive action)is the result of a US FDA requirement, FDA 21 CFR 820.100. The CAPA requirement applies to manufacturers of medical devices and compels them to
What is CAPA and Why You Need It? Read More »
Plans Regulations for Critical Medical Devices Government plans rules for critical(implantable) medical devices like pacemakers, CT scanners X-ray machines. • To regulate the sale, • manufacturing • import of implantable medical devices The main aim is to ensure that medical devices that are implanted in the human body are tested for safety before they reach
Government Plans Regulations for Critical Medical Devices Read More »
FDA Inspections and ISO Audits As you can see there is a huge difference in inspection and audit, Audit is an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies or procedures,
FDA Inspections and ISO Audits Read More »
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 Nomenclature Read More »
Introduction to Singapore Medical Device Registration Curious about the ins and outs of getting your medical device approved by the Health Sciences Authority (HSA) in Singapore? You’re in the right place. Singapore’s advanced healthcare system and strategic location make it a prime market for medical devices. But how does the approval process actually work? In
Singapore Medical Device Registration – HSA Approval Read 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 Rules Read More »
