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Want to Master Medical Device Regulation learn how to put a product on the market in Europe Easy Medical Device is a platform for tools and resources for Regulatory Affairs Quality Management Regualtory Compliance Learn how to choose your notified body or how the device regulation is different in other countries
A medical device may contain an ancillary medicinal substance to support the proper functioning of the device These products fall under the medical devices legislation and must be CE marked Examples of medical devices with an ancillary medicinal substance include drug eluting stents bone cement containing an antibiotic catheters coated with heparin or an antibiotic agent and condoms coated
CDSCO Central Drugs Standard Control Organization is the national regulatory body for Indian medical devices and pharmaceuticals and serves parallel functions to the European Medicines Agency of the European Union the FDA Food and Drug Administration of the United States and the medications and healthcare products Regulatory Agency of the United Kingdom
protection in the form of regulatory exclusivity At times there has been disagreement between FDA and product sponsors regarding the jurisdictional determinations of certain drugs and devices and drug device combination products In addition as new scientific evidence becomes available FDA may reconsider previous determinations
Research Involving Drugs and Biologic Products Review of a study involving the research related administration of a drug or biologic occurs at a convened IRB meeting unless the research activities present no more than minimal risk and an IND is not required in accordance with expedited review categories An IND is commonly required for any clinical investigation that proposes the use e g
In the early part of the 20th century the U S Food and Drug Administration FDA was given the responsibility for ensuring both the safety and efficacy of drugs prior to marketing Amendments to the Federal Food Drug and Cosmetics Act in 1976 expanded the agency s role to oversee safety in the development of medical devices Whereas new drug approval takes an average of 12 years moving
How much do you know about the safety and effectiveness of the implanted devices your patients are offered You may assume that pacemakers neurostimulators joint prostheses and breast implants have been tested rigorously before being licensed for widespread use But this week a major international investigation involving 59 organisations and including The BMJ finds device regulation
Approval of medical devices in both the EU and the United States share some similarities The FDA assigns devices to 3 main regulatory classes low risk or Class I moderate risk or Class II and high risk or Class III the United States a Class I device requires merely a Premarket Notification without clinical trials whereas Class III devices require clinical trials and/or other
Sep 20 2016 #4 Sep 20 2016 #4 I ve got two resources for you The first is the FDA guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations You can easily identify medical device QSR elements part 820 in part 211 It is here The second is the Pharmaceutical Supplier standard PS 9000
The medical device UDI regulation defines end dates for placing legacy NDC/NHRIC identifiers on medical device labels based on UDI Compliance Dates Supporting MaterialTo further support the position that the Combination Product is considered/regulated as a medical device consider providing links to a few representative product records
China Medical Device IVD Regulatory Webcast The comprehensive China Medical Device IVD Regulatory Webcast provides in depth information on China s medical device and IVD regulations and the product registration requirements and timelines Other key topics include updated clinical trial and good supplier practice GSP requirements re registration reimbursement labeling
Express Preemption of Consumer Protection Actions Preventing a Patchwork of State Drug and Device Regulations Charles Byrd non prescription drugs medical devices
Unapproved medical device is a device that is utilized for a purpose condition or use for which the device requires but does not have an approved application for premarket approval under section 515 of the Federal Food Drug and Cosmetic Act 21 U S C 360e the act or an approved IDE under section 520 g of the act 21 U S C 360j g IDE An approved investigational device exemption
To launch a medical device the manufacturer has to adhere to numerous norms set by way of the countrywide regulatory bodies of India The number one regulatory frame for medical devices in India is the central drugs trendy control organization The applications for all elegance of scientific gadgets are made to the important licensing Authority CLA in which the Drug Controller General of
Notice Guidance Document Classification of Products at the Medical Device Drug Interface February 7 2018 Our file number This guidance document was first published on January 30 2013 as Factors Influencing the Classification of Products at the Device Drug Interface The present revision is intended to reflect the
In Japan drugs and medical devices can be designated as orphan drugs or medical devices based on the Article 77 2 PDF 87KB of the Act on Securing Quality Efficacy and Safety of Pharmaceuticals Medical Devices Regenerative and Cellular Therapy Products Gene Therapy Products and Cosmetics if they are intended for use in less than 50 000 patients in Japan and for
The medical device UDI regulation defines end dates for placing legacy NDC/NHRIC identifiers on medical device labels based on UDI Compliance Dates Supporting MaterialTo further support the position that the Combination Product is considered/regulated as a medical device consider providing links to a few representative product records
Designated Drugs and Designated Medical Devices means a Drug including APIs and Excipients or Medical Device respectively designated for
Medical device manufacturers issued 1 267 product recalls affecting more than 441 million individual devices in 2018 according to Stericycle Expert Solutions a tech firm that tracks consumer recalls Software issues were the most common reason behind medical device recalls accounting for
Designated Drugs and Designated Medical Devices means a Drug including APIs and Excipients or Medical Device respectively designated for
Medical product classification determinations often focus substantially on whether a product that meets the definition of drug also meets the statutory definition of device
The Medical Device Single Audit Program MDSAP is designed to allow a single audit for medical device manufacturers that is accepted in multiple countries Led by various Regulatory Authorities RA worldwide the initiative is aimed at enlarging efficiency and safety through increased consistency
Medical devices are products that have a medical purpose and are intended by the manufacturer for use in humans In contrast to medicinal products that act pharmacologically immunologically or metabolically the main intended purpose of medical devices
The Food and Drug Administration FDA is the oldest comprehensive consumer protection agency in the United States The FDA s oversight of food and drugs
drug medical device or API inventory has been accounted for reclaimed and/or disposed of properly For each new out of state location attach a copy of the resident state wholesale license
2 days ago About us The Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte BfArM is an independent federal higher authority within the portfolio of the Federal Ministry of Health At the BfArM roughly 1 250 employees physicians pharmacists chemists biologists lawyers engineers technical assistants administrative staff etc are involved in
Local health departments can also assist with instructions for disposal or the retrieval of sharps disposal containers The local waste management service may be able to answer questions about whether certain drugs or devices can be disposed of in a person s trash
Addressing ingress protection for home healthcare medical devices requires ingress protection for the majority of medical device types because it is reasonable to foresee that the devices may accidentally be subjected to liquids resulting in risk of harm to the patient A thorough understanding of applicable portions of and 60529
Medical devices are health products which have a physical or mechanical effect when used on human bodies These devices are used to Diagnose alleviate or treat a medical condition e g X ray machines contact lenses prosthetic knee implants Measure or monitor functions of the body e g blood pressure or blood sugar monitoring machines
the Federal Food Drug Cosmetic FD C Act define medical device as an instrument apparatus implement machine contrivance implant in vitro reagent or other similar or related article including any component part or accessory which is 1 recognized in the official National Formulary or the United States Pharmacopeia or any
New device can provide improved protection to newborns on ventilators If a newborn is moved or becomes agitated while on a ventilator the breathing tube also could move Just a
Expert insights about medical devices and specialty drugs from top distributors in Hong Kong and Greater China The U S Commercial Service in Hong Kong recently met with two leading distributors of medical devices and pharmaceutical products that are looking to supply more U S products into the Hong Kong and Macau markets
The approval process for new drugs is typically longer than the approval process for medical devices While it takes 12 years on average to bring a new drug to market the average length of time it takes to bring a medical device to market is three to seven years However this does not always mean it s easier to obtain approval for a new
One of the key challenges for medical device companies is finding a CRO with the correct experience and expertise for their trial Although device trials have a few core similarities to drug trials they have many different requirements and a common presumption for some CROs is that if they have been involved with a drug trial in the past they will be able to take on the responsibility of a
Chinese mainland reports 47 new locally transmitted COVID 19 cases The Chinese mainland on Thursday reported 47 new locally transmitted COVID 19 cases including 26 in Jiangsu Province 14 in Henan four in Hubei two in Hunan and one in Yunnan the National Health Commission said in its daily report on Aug 13
Patent protection and the market exclusivity that comes with it help to ensure a return on investment A patent holder has the right to exclude others from making using and selling the patented invention for a defined period Therefore patented drugs are temporarily safe from the competition of generics often resulting in substantial revenues
