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Introduction United States Food and Drug Administration (FDA) regulates all medical devices manufactured in the U.S. The FDA regulations, coupled with European Commission regulations, nearly cover all international distribution of medical devices. However, not all manufactured medical devices go through the same regulations. Depending on the possible risk factors, safety, and reliability of the devices,…
Everything You Need to Know About EUDAMED: Preparing for the New Medical Device Regulation EUDAMED is the EU medical device database that came into effect in May 2021. The regulation, known as MDR (Medical Device Regulation), replaces the Medical Devices Directive (MDD) and sets new standards for medical device registration and market surveillance. It is…
ISO 13485 training No medical procedure comes without risk, but this can be reduced through effective risk management and regulation of medical devices. A medical device is any instrument or machine used to diagnose, prevent, or treat medical conditions and diseases. ISO 13485 is a global standard used to audit businesses that use devices for…
Searching the FDA 510k Database for Regulatory Strategy: What Medical Device Manufacturers Need to Know? The FDA 510k database is an important tool for medical device manufacturers. Understanding how to use it can help you stay compliant with FDA regulations and strategically plan your regulatory strategy in the United States. Perform FDA 510k database search…
Everything You Need To Know About Medical Device Coordination Group (MDCG) The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The group is mainly known for publishing MDCG guidance starting…
Understanding the Differences Between MDD vs MDR: The European Regulation There are many regulations in place that govern how medical device manufacturers can produce and supply their products. The EU has a few different regulatory requirements for medical devices. In Europe, there is the MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation).…
How to Comply with the New ISO 13485 2016 Standard? ISO 13485 2016 (or EN ISO 13485 2016 for Europe) is the latest standard for medical devices. It was published in July 2016, and it has a lot of changes from ISO 13485:2003. ISO 13485 2016 includes new requirements for quality management systems and documentation…
EU MDR harmonized standards first set released The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR harmonized standards and reference requirements can be used for that…
What is the new EU MDR? Everything you need to know The European Union (EU) Medical Device Regulation is the latest step in regulating medical devices in the European Union and has been developed to strengthen the monitoring of the medical devices on the market and their manufacturers. The EU MDR has been made effective…
What is UDI Unique Device Identification or UDI is a system that provides harmonized positive, globally and single identification of medical devices through usage and distribution. The system has two parts, which are UDI-PI and UDI-DI. The UDI-DI is the device identifier that has the power to identify a particular device within your portfolio, which…
ISO 14971 RISK MANAGEMENT FOR MEDICAL DEVICES Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to do is to make sure that your devices do what they are supposed to do. Then, you need to make sure that they meet the set regulations and standards for…
What is the IVDR? There has actually been an EU Directive (98/79/EC) controlling in vitro diagnostic medical devices (IVDs). Nonetheless, troubles emerged with the analysis and also application of that Directive, especially that it provided only reduced degrees of examination for possibly ‘high risk’ devices therefore EU IVDR regulation was enacted. IVDR meaning is:…
Keeping Your Medical Devices Safe with the Latest Cybersecurity Solutions In the ever-changing world of medical devices, one thing is for sure: the FDA and other regulators have been taking a much closer look at what needs to be done in order to keep patients safe in this connected world. In fact, the FDA’s guidance…
Health Canada collects post-market information from a wide variety of sources after products are approved for sale in the Canadian market, then evaluates information to come up with appropriate safety measures involving medical devices. Signal detection and assessment Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through the…
“Software as a Medical Device (SaMD)” – A New Trend in Healthcare Software as a Medical Device (SaMD) is an innovative trend in healthcare. SaMD software bridges the gap between medical devices and information technology, using software to improve patient care. It has been growing steadily over the past few years, but only recently have…
Class III Medical Device A series of medical devices are available on the market, and are classified into different sub-categories like Class I, Class II, and Class III devices. As per “the Food and Drug Administration,” the medical devices are classified into these three categories. Out of which, you will get to know about Class…
Free access to ISO 13485 standard, other medical device and personal protection equipment standards To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily…
ISO 13485 certification is a requirement for medical device companies that wish to market their products in Europe and around the world. What is iso 13485 certification ? The ISO 13485 standard was published by the International Standards Organization to give medical device firms with needs for developing and maintaining quality systems. While medical device…
Responsible Authorities in Korea FDA Medical devices in South Korea are managed by Medical Device Act and controlled by The Ministry of Food & Drug Safety (MFDS) or formerly Korea FDA. Under the jurisdiction of the Act, requirements for medical devices are provided in numerous various titles of guidelines. Below is a list of the…
FDA 510k: Everything you need to know about preparing a premarket submission for medical devices A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the…
EU MDR Post-market Surveillance System The European Medical Device Regulation 2017/745 requires establishing a post-market surveillance system once the medical device is on the market. The EU MDR Post-Market Surveillance requirements will be explained below: PMS system is established for the following: For each device: variants can be grouped for a device but the PMS…
EU MDR Technical Documentation Summary The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. See below a summary of the information to be included to comply with EU MDR Technical Documentation. The manufacturer shall develop technical documentation for each of its devices[1]. The technical documentation must be such that it allows the…
Definition of UDI from the MDR EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a new requirement to achieve the CE marking of a medical device. The European Medical Device Regulation 2017/745 defines the UDI as follow: (15)‘Unique Device Identifier’…
EU MDR clinical evaluation EU MDR clinical evaluation requirements are quite overwhelming. There are a lot of requirements and the strategy to achieve conformity is not always clear. We cover those requirements in detail. In order to show conformity with general requirements in terms of safety and performance to determine adverse effects and to evaluate…
EU MDR risk management EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are carried out. He must update it periodically and systematically throughout the life cycle of each device[1]. In order to ensure risk management, the manufacturer must:…
EU MDR standards The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR standards and reference requirements can be used for that purpose. The manufacturer may benefit…
Medical Device Classification in the EU MDR One of the first concerns for manufacturers of medical devices attempting to sell their products on the European market is to decide what class is suitable for their products. The Medical Device classification in the EU MDR of the product can affect how and when the notified body…
EU MDR – Guide overview Below is a summary of different activities pertaining to the EU MDR (Europe Medical Device Regulation 2017/745). Compliance with EU MDR requirements is mandatory since May 26, 2021. Our summary includes the following sections: Summary of obligations from the manufacturer Summary of obligations of the manufacturer concerning his devices before…
Consultants Hiring Problems and Solutions: we will try to address here the main issues companies may encounter during and after the hiring process of a quality and regulatory affairs consultant. Lack of experience with the device classification You wouldn’t be fit to prepare some elaborate meal if all you had done so far were pasta.…
Medical Device Regulation date of application postponed The European medical device regulation 2017/745 have been postponed one year later in order to avoid shortages in getting key products available on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) which was initially enforceable on 26 May 2020 will now become fully effective on…
PreMarket Medical Devices in Canada Applicants, may it be the manufacturer, importer, or distributor must obtain a license before their product is released to the Canadian market (PreMarket Medical Devices in Canada essential step). This is true for all types of products, may it be drugs, foods, cosmetics, and even medical devices. Products which fall…
Post market surveillance in Europe One of the changes in the new European Medical Devices Regulation (MDR 2017/745) is the strengthened post market surveillance requirements for medical device manufacturers in order to register their product in the European Union. This requires manufacturers for each medical device to plan, establish, document, implement, and maintain a post…
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes that occured in the new guidance.
MEDDEV 2.7.1: clinical evaluation New Regulation on Clinical Evaluation One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer.…
What happened before the EU Medical Device Regulation and In vitro Diagnostic Regulation ? See what changes in EU medical Device Regulation. The existing European regulatory framework originated in the 1990s consists of three directives designed to regulate about 500,000 types of medical devices (e.g. contact lenses, breast implants, x-ray machines, pacemakers) and in-vitro diagnostic…
South Korea regulation changes in 2018 The following regulatory changes are expected in 2018 in the South Korea regulation as published by the MFDS (Ministry of Food and Drug Safety): Main regulatory changes in South Korea regulation Adopt customized licensing system for advanced medical devices – ‘Special Act on Promotion of Advanced Medical Device Development…
Korea becomes the 10th member of IMDRF After the U.S., EU, Canada, Australia, Japan, China, Brazil, Russia, and Singapore, Korea has become an official member of the International Medical Device Regulatory Forum (IMDRF). This was announced officially on the Korea MFDS (Ministry of Food and Drug Safety) website as of December 11, 2017 and it…
Innovative medical devices in Korea – forecast analysis report The Korean MFDS published a forecast analysis report for innovative medical devices in South Korea. The link to the report is here. To help the medical device companies, Korean MFDS prepared and distributed the reports on the status and prospects of innovative medical devices(medical devices manufactured with…
KGMP guideline revision The Korean GMP (KGMP) guideline has been updated earlier this year (2016) and even if it was only provided in Korean we prepared a translated version in English. More details were provided in the guideline and the case of in vitro diagnostic equipment was considered since those were reclassified as medical devices.…
2016 is here now so Happy New Year first of all ! So in Korea now we are all one year older. Yes, A baby in Korea will not gain one year on his or her birthday. Instead, people will gain one year together on January 1st of every year (New Year’s Day). This is what “Korean age” is.…
This guideline for pulse oximeters was prepared to help the writing of the technical documentation and subsequent approval. pulse oximeters are commonly used to measure the concentration of oxygen in the blood. Main content of this guideline includes: medical equipment approval authorization process approval and technical requirement items, and examples of technical requirements. MFDS Evaluation…
Korean Ministry of Food and Drug Safety MFDS has announced that in order to expand European market of medical devices they are holding a working meeting at the MFDS office with Polish and Czech pharmaceutical and medical equipment registration office. This working meeting was arranged to follow up with high level officer meeting in 2013…
This guideline for polypropylene suture was prepared to help the writing of the technical documentation and subsequent approval. Polypropylene suture is a non-absorbable type of suture used for approximating and ligating soft tissue. Main content of this guideline includes: medical equipment approval authorization process approval and technical requirement items, and examples of technical requirements. MFDS…
In some cases performance requirements are not defined in the Korean regulation. That’s sometimes a good thing, and sometimes not. Performance test in Korea, means confirmation of the intended use and functional test at the same time. Let’s say for instance in the case of active devices, compliance with a particular standard like IEC 60601-2-X…
MFDS recently revised its handbook in order to align with STED guidance from International Medical Equipment Standardization Technical Documents. The revision of MFDS guidelines STED includes more checklists, example and comments to improve the level of clarity. The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global…
Korean MFDS guidelines ECG HF stimulation was recently published (June 12, 2015) in order to help completion of medical device license and technical documentation. The products covered are high frequency stimulation and electrocardiograph. The guidelines describe a variety of high-frequency stimulation of different properties/techniques as well as electrocardiographs. The structure of the guideline is such…
China International Medicinal Equipment Fair (CMEF), founded in 1979, is held twice a year – spring and autumn. After 30 years of continuous innovation and self-improvement, CMEF has become the largest exhibition of medical equipment, related products and services in the Asia-Pacific region. The exhibition widely covers ten thousands of products such as medical imaging,…
Important reminder: the Ministry of Food and Drug Safety MFDS has expanded its list of implants subject to tracking. The implants traceability requirements were already defined. Until Dec. 31, 2014 there were only 28 products in that category and now the list expanded to 52. Among the 24 new products in the list: artificial blood…
Korean Health Industry market over the past decade has shown a growth of more than twice.Exports also increased more than four times as per 2013 record of $ 5.76 billion compared to $ 1.5 billion in 2004. Korea Health Industry Development Institute is publishing a report “health industry over the past 10 years and future direction”.…
KFDA Notification No. 2014-178 2014.10.31 The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that several changes would occur and is collecting opinions from the industry. The original publication can be found here (published on Feb. 2, 2015).…
Reclassification and re-categorization of medical devices The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that a reclassification and re-categorization of products would occur. Reclassification of 244 products previously known as in vitro radio-pharmaceuticals to medical devices guideline…
The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents. The aim of such guidance is to address some of the best practice expected from manufacturers and Notified Bodies. The guidance documents can be found on the below link: 1. NBOG BPG 2014-3 – Guidance for manufacturers and…
Local Representation in Korea Appointing a Korea license holder is to be taken seriously. If you don’t, you may end up in a dead end with products you cannot put on the market. Here below we get into the details of what is a license holder, its responsibilities and other topics. It came from the…
Following our webinar series where we focus on medical devices registration in South Korea, we also made it possible to join, share and discuss topics related to Korean medical devices regulation and exports to Korean market via the hashtag #medical2korea. It can be used for the following : Tweet Chats (once a week) Ad-hoc advices…
Background Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor ready ? After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution…
In the following pictures we added an overview of the clinical trial regulation in Korea. It gives an overview of the process for clinical study in Korea. We recently had lots of discussions on how to conduct studies we thought a brief reminder would be welcome. The first table is about the process when investigator…
We recently launched our webinar series where we focus on medical devices registration in South Korea. We address different topics such as : How to set up the best strategy to sell your medical device in South Korea: distributors, legal terms How to get clearance from a regulatory point of view: Korean Good Manufacturing Practice,…
Notification of regulation amendment regarding approval, notification and evaluation of medical devices in Korea. A) Implantable Medical Device B) Restricted substances C) Intended Use D) Clinical Evaluation E) Medical apps Korean medical devices regulation update 2014-142 A) Implantable Medical Device The definition of Implantable medical device and its application (Article 2 and Article 5) 1)…
borderline and classification medical devices: UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014) Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable…
Statement of Cooperation Among FDA – TGA – ANVISA – HPFB: MDSAP pilot According to the SOC (Statement of Cooperation), the “Participants” composed of the The United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB) aims…
Ministry of Food and Drug Safety Notice No. 2014-155 was published on MFDS website. The Korean Good Manufacturing Practice (KGMP) being revised and this is a public consultation. South Korea medical device registration will be affected by this publication. The purpose here is clearly to improve the way KGMP is managed. Below is a summary…
Korean Ministry of Food and Drug Safety (MFDS) recently released a revision of its reference standard as per Ministry of Food and Drug Safety Notice No. 2014-122 affecting South Korea medical device registration. The purpose is to align with international standards related to electrical and mechanical safety. Are covered the following: radiation safety, usability, alarm…
Which one comes first among: KGMP (Korean Good Manufacturing Practice), product license, TDR (Technical Document Review) ? This is not a quiz, however often people are puzzled as to which one to apply for first. So far, the sequence has been like this: TDR product license KGMP The reason was that you needed the application…
A public consultation was published regarding the South Korea medical device regulations as below (Ministry of Food and Drug Safety Notice No. 2014-88 as of April 18, 2014) original notice is here: 1. Reasons for Revision A. Exempting license/notification of medical device for emergency such as life-threatening situations B. Clarifying the range of restriction…
A notice is given for Limited Revision regarding Medical Device Act 1081; released May 9, 2014 of the South Korea medical device regulations as below: 1. Reasons for Revision A. Subcontracting B. In-Vitro Diagnostic C.License Modification exemption D.Distribution Quality Management Standard E.Periodic Reporting F. Recall Notification The pharmaceutical drugs and the medical devices are currently…
Having visitors is not always a pleasure. On top of that some of them have the right to step in. So it’s better to be prepared for that situation and deal with it no matter what happens. How do you deal with Notified Body Unannounced Audits announced to be taking place soon (if not already)…
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change ? Since it is very hard to figure out just by reading the publication on the Official Journal of…
Limited Revision Notice regarding Biological Safety of Medical Devices published by South Korea MFDS Reasons for Revision (biological safety medical devices) The international requirements regarding the biological safety for medical devices that are internationally accepted has been partially changed subsequent to the revision of International Standards for medical devices (ISO 10993-4, 9, 10, 13, 16).…
Here is the Ministry of Food and Drug Safety Notice No. 2014-87 from South Korea. South Korea MFDS is revising 「Regulations regarding Medical Device Products and Product Classification」 (Ministry of Food and Drug Safety Notice No. 2014-88, 2/12/2014) in part, and gathering consensus from the people. They are hereby giving a notice regarding the purpose,…
As per Notice from MFDS: The Heart Rate Monitor and Pulse Monitor that are used for exercise and leisure purpose need not be included in the product classification for the medical purpose. In defining the Heart Rate Monitor and Pulse Monitor, those that are designed for exercise and leisure will be excluded (Appendix A26080.01, A26080.02).…
Finally available. Our translation of the Korean GMP Revision 2 in English is ready. The document was validated and is now ready for review. The main modifications are summarized below: Removed GMP inspection for class 1, but tightened for class 2, in the past, for class 2 only document inspection required, but since Jan 2014 it has been changed to site…
Kobridge Director, Nicolas Clary, will be participating in a free webinar hosted by LNE/G-MED the French Notified Body. The topics covered in those webinar are mostly aimed at introducing foreign regulations. Korean medical devices regulations will be covered on the same slot as Japan. Each slot is 45 minutes long. The date of the webinar is…
On April 2nd 2014, Ministry of Food and Drug Safety published on their website the second revision of their Korean GMP guideline. The analysis of the changes is currently being made and we will soon be able to provide a gap analysis as well as an English version of the document. Changes include for instance…
In a very similar way as US FDA addressed this topic, South Korean MFDS has announced measures to distinguish mobile medical devices from more fitness related application or devices. The original public consultation is posted here. Comments from the public can be submitted until April 7, 2014. For instance, heart rate monitors and pulse rate…
How to search for Korean Standards Following a request from one of our subscribers, here is a brief video to quickly find information about Korean Standards in English. Find out if an English version exists and if the Korean version is identical or modified. The video is on our recently created Youtube channel: http://youtu.be/T7V3vxWIQHs The…
Medical device registration in Korea: appointing medical device quality manager for class 1 products In case of class 1 medical devices, the voluntary system that allow manufacturers/importers to manage quality control internally was adopted. However, the current medical device act does not require the manufacturers/importers that are seeking licensing to employ the medical device quality…
Korean labeling requirements: One of our subscribers raised the point of labeling requirements specifically asking if it was necessary to include the “manufactured by…” and “Made in …” on the labels. Let’s review below what are the requirements including this one so that we get the overall picture. On the device label product name model…
inspection of dealers or rental agencies by inspection agencies designated by MFDS Korea In the past, when purchasing a medical device from medical institutions, the medical device dealers or rental agencies, were required to obtain qualifying inspection from the manufacturer or importer of the said medical devices regarding the manufacturing and quality control standards of…
Segmentation of products for Korea MFDS A new segmentation for 4 products including absorbable coronary stent was issued by MFDS recently in order to add some clarity. (from MFDS on Jan. 14, 2014) The following products are concerned: A09230.02 Artificial Kidney Filter System Class 3 A79110.02 Medication Dosage Regulator Class 3 B03300.15 Absorbable Coronary Stent…
Public consultation about IEC 60601-1 third Edition implementation in South Korea The current dates for the implementation of IEC 60601-1 3rd Ed. (electrical safety) are as follow: June 1, 2014, all Class 3 and Class 4. Class 2 June 1, 2015 Class 1 June 1, 2016 However, there is a public consultation in-progress now. The…
Staying up to date requires a lot of time and effort when you are working in the medical devices industry. You need first to select the proper source of information then filter to match with your product category. Finally you only can guess which standard could be appropriate. Medical Standards List is a new service…
It’s not only a name change in fact. Of course the Korean FDA became The MFDS (Ministry of Food and Drug Safety), but beyond that the agency has been promoted to a ministry level.
Technical document review A technical document review is a general “technical document review” (TDR) for those products that are basically the same as an already approved product, whereas a “safety and efficacy review” (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new intended use,…
Starting here is a serie of posts related to Korean Regulation, the first one being about South Korea KGMP inspection requirements which is equivalent of the US Good Manufacturing Practice. Quality system regulations (KGMP) All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III…
Update on the above can be downloaded from the following link: http://we.tl/jjpqSeTDYm.Thanks to our correspondent in Europe White-Tillet firm. 3 reports can be downloaded: HEALTHCARE POLICY & REGULATION, DRUGS & BIOLOGICS, MEDICAL DEVICES & COSMETICS/BIOCIDES.
Manufacturers of medical devices in Europe won’t need to change their labeling. Initially EN 980:2008 was about to be replaced by EN ISO 15223-1:2012 but as stated by the European Commission that won’t be the case. Some people were surprised seeing that no standard related to symbols was addressed anymore in the list of harmonized…
There is a new release of the certification rule NF227 (Rev.9). The link to the content is here : http://www.marque-nf.com/appli.asp?NumAppli=NF227&Lang=English# Clicking on NF227 will then give the list and access to the content. So far it’s in French but the English version can be obtained upon request. Few modifications: Most important is the routine tests…
Will the breathalyzers be still mandatory in french cars in 2013? According to our information, the Secretary of State for the Home Department, Manuel Valls, should call the National Road Safety (NCRP) to assess the relevance of this mechanism intended to allow drivers to self-test before driving. If the NCRP believes that this equipment is…
