The Indian medical device sector has been observed an increased interest from the MNCs which have stepped up their footprints in India, along with detecting their key research centres in the Indian cities. The Apex industry body ASSOCHAM has recommended that the Indian firms engaged in the manufacture of medical devices, be enabled faster access […]
Faster access been given to Indian medical device firms on US-FDA Read More »
The Brazilian regulatory agency is the so-called ANVISA (National Health Surveillance Agency) is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. ANVISA The agency is associated with the Ministry of Health, which manages ANVISA through a management contract signed periodically. The role of ANVISA’s is
ANVISA rolling out new regulations for custom-made medical devices Read More »
The Kingdom of Saudi Arabia is one of the largest markets for medical devices and associated products in the Middle East region. As part of the Gulf Cooperation Council (GCC, also known as the economic union of the six Arab states), Saudi Arabia has experienced extraordinary growth, primarily due to its hydrocarbon-based economy. In Saudi Arabia,
Kingdom of Saudi Arabia – Operon Strategist Read More »
FDA has the authority to inspect factories that manufacture products regulated by the FDA. One way that the Food and Drug Administration (FDA) secures public health and guarantees compliance with the Food, Drug and Cosmetic Act is by leading inspections of clinical preliminary trial investigators, clinical trial sponsors, Institutional Review Boards (IRB) and facilities that make
How to Respond FDA Form 483 and Warning Letters | Know its differences | FDA Read More »
The term medical device covers a vast range of equipment, from simple tongue depressors to haemodialysis machines. Like medicines and other health technologies, they are essential for patient care – at the bedside, at the rural health clinic or at the large, specialized hospital. The International Medical Device Standard is something that is used for
International Medical Device Standards: A Look at the ISO 13485 and ISO 14971 updates Read More »
The Design and Development of the product play a vital role in the total life cycle of a product and to ensure the effective and safe product in the market. The adequate design documentation helps to improvise the product performance while the product remains in the market. As per FDA data, the significant portion at
Importance and Regulatory aspects of Design Control Read More »
Labeling Refers to All of the Information Provided With the Equipment. Which Includes: Symbols, labels, instructions, warnings, and control labels are applied to medical devices using color coding, molding, machining, or printing. The information appears on the medical equipment. The device came with installation, user manuals, and maintenance instructions. Details are printed on the device
4 Common Misconceptions About Medical Device Labeling Read More »
Design controls for medical devices demonstrate that the medical devices are safe, effective, and meet the indications for use. A medical device design that adds value to end user and simultaneously captures profitable market share is really a tough job. Design controls for medical devices and development of a medical device is the most crucial
The Ultimate Guide to Design Control for Medical Device Companies Read More »
Medical Device Development : High-risk medical devices are not easy to launch as of layers of regulations. The main purpose of launching a medical device is to ultimately profit others while keeping the end-user and patient safety with less risk involved.Medical device professionals can assist explain regulations that are usually lawyers as of the immense
Effective phases of Medical Device Development Read More »
Incompatibility of the arrangements of sub-control (2) of rule 18 of the Medical Devices Rules 2017, the government of Maharashtra as created a rule where a notification is circulated to all the appointed drug inspectors under subsection (1) of section 21 of the Drugs and Cosmetics(D&C) Act, 1940 as the medical device officers for actualizing
Medical Devices Rules 2017, the government of Maharashtra Read More »
