Emergo Group

http://www.emergogroup.com/

Last activity: 03.03.2017

Active - Reference to Emergo by UL

Mentions

347

Overview

Employees

51-200

Founded date

1997

Mentions in press and media 347

Date	Title	Description
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Jul 14, 2015	bb7 expands into new territory	bb7, a comprehensive product development firm headquartered in Madison, Wisconsin, announces its expansion to Boston, Massachusetts. This new presence is part of a committed growth strategy aimed at better supporting the East Coast Medical ...
Jun 15, 2015	Peruvian regulators place new requirements on medical devices with PVC components	By Stewart Eisenhart, Emergo Group DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and laeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexy...
Jun 4, 2015	Thinking about entering Middle East medical device markets? Avoid these 3 common mistakes made by ‘westerners’	By Emad Elmasry, Emergo Group In my 25+ year career working with multinational device companies, I have worked with a lot of American and European executives. The vast majority are smart and well intentioned. But time after time, companies ...
Jun 4, 2015	US FDA proposes changes to MedWatch program for healthcare products	By Stewart Eisenhart, Emergo Group US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical pr...
Jun 3, 2015	Saudi regulators issue new guidance on investigational medical devices	By Stewart Eisenhart, Emergo Group The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country. ...
May 22, 2015	Substantial medical device review fee increases at Taiwan Food and Drug Administration	By Stewart Eisenhart, Emergo Group Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015. The ...
May 21, 2015	Seven mistakes that can delay your FDA 510(k) clearance	By Stewart Eisenhart, Emergo Group Based on data provided by the US Food and Drug Administration as well as Emergo consultants’ experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been...
May 18, 2015	FDA guidance outlines principles for adaptive design in device clinical trials	By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data w...
May 12, 2015	Latest data from Health Canada on MDL screening deficiencies, additional information requests	By Stewart Eisenhart, Emergo Group Health Canada has released new information regarding common issues its reviewers found over the course of 2014 and early 2015 with higher-risk Medical Device License (MDL) applications that result in addit...
May 6, 2015	US FDA’s GUDID now publicly accessible	By Stewart Eisenhart, Emergo Group Medical device market regulators in the US have launched a new website to provide public access to their Global Unique Device Identification Database (GUDID) designed to store device labelers’ information ...
May 5, 2015	Hong Kong regulators launch voluntary distributor registration system	By Stewart Eisenhart, Emergo Group Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a voluntary listing and registration option for device distributors. Distributors who apply for li...
Apr 30, 2015	US FDA identifies more than 20 PMA devices eligible for reclassification to Class II	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part ...
Apr 30, 2015	In brief: European regulators make radio and wireless revisions, update website	By Stewart Eisenhart, Emergo Group Although major news regarding new European medical device regulations remains forthcoming, European Commissioners have recently rolled out a new directive for devices using wireless components and reorgani...
Apr 28, 2015	UDI is here: Seven things you need to know	By Stewart Eisenhart, Emergo Group Now that US medical device regulators have begun implementing their Unique Device Identification (UDI) system, many device manufacturers are questioning how best to comply with the new requirements in the ...
Apr 23, 2015	US FDA explains criteria for accepting medical device clinical data from foreign studies	By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also...
Apr 17, 2015	Major changes set for Taiwan’s medical device registration process	By Stewart Eisenhart, Emergo Group The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory ...
Apr 15, 2015	US FDA rolls out expedited access program for medical devices	By Stewart Eisenhart, Emergo Group US medical device market regulators are launching a new expedited market access program for select high-risk devices targeting life-threatening diseases or ailments. First proposed in early 2014, the Exped...
Apr 14, 2015	Malaysian fast-track registration pathway unveiled	By Stewart Eisenhart, Emergo Group Medical device market regulators in Malaysia have set rules for a fast-track registration process available for some medical devices between April 10 and June 30, 2015. The Malaysian Medical Device Authori...
Apr 10, 2015	Malaysian regulators lay out post-market surveillance audit framework	By Stewart Eisenhart, Emergo Group Malaysia’s Medical Device Authority, responsible for overseeing the country’s medical device market, has published new draft guidance on post-market surveillance regulatory audits for manufacturers authori...
Apr 10, 2015	IMDRF weighs in on QMS requirements for software as a medical device	By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published new guidelines for how software developers whose products are considered medical devices may be affected by quality management system...
Apr 2, 2015	May 2015 deadline for comments on Health Canada’s Special Access Program for medical devices	By Stewart Eisenhart, Emergo Group The comment period for new Health Canada guidance on the regulator’s program for providing healthcare professionals access to unlicensed medical devices under qualifying circumstances will end in late May ...
Apr 1, 2015	US FDA sheds light on medical device advisory panels	By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains the role of specialized advisory panels in medical device regulatory issues including classification and marketing authorization determination...
Mar 24, 2015	Pakistani government publishes new medical device and IVD registration rules	By Stewart Eisenhart, Emergo Group Pakistan’s Drugs Regulatory Authority has issued new medical device and in vitrodiagnostic (IVD) regulatory requirements, the Medical Devices Rules, 2015, that have gone into effect. The new regulations in...
Mar 20, 2015	Final US FDA guidance on instructions and labeling for reprocessed medical devices	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products. The new guidance also lists recommendations...
Mar 19, 2015	Risk management by Regulatory Authorities	By Ronald Boumans, Emergo Group Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away from th...
Mar 16, 2015	South Korean regulators to require clinical data for many Class IV medical devices	By Stewart Eisenhart, Emergo Group South Korea’s medical device market regulator, the Ministry for Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such r...
Mar 10, 2015	US FDA Amends eMDR Rules to align with Unique Device Identification Program	By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities ...
Mar 10, 2015	New medical device classifier complicating Russian registrations	By Stewart Eisenhart, Emergo Group A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for gr...
Mar 6, 2015	New regulation harmonizes Brazilian clinical testing requirements with international standards	By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country. The new regulation, RDC 10/2015 (link in Portuguese), est...
Mar 2, 2015	National US postmarket surveillance system takes further shape	By Stewart Eisenhart, Emergo Group A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical dev...
Feb 17, 2015	New guidance clarifies Saudi labeling requirements for medical devices	By Stewart Eisenhart, Emergo Group The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). The guidance clarifies labeling rules...
Feb 16, 2015	Health Canada: CMDR compliance will be required for single-use reprocessed devices	By Stewart Eisenhart, Emergo Group Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2016. According to Canad...
Feb 13, 2015	Educated Guess: US Medical Device Excise Tax here to stay through 2016	By Stewart Eisenhart, Emergo Group Since its implementation in 2013 as part of the Affordable Care Act (ACA), the Medical Device Excise Tax (MDET) has drawn steady fire from industry trade groups and their allies in the US Congress. So far,...
Feb 10, 2015	Indian regulators consider pre-submission consulting for medical device registrants	By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) is seeking comment on a new proposal to establish formal pre-submission consultations with firms seeking medical device registration in the count...
Feb 10, 2015	Updated final guidance for MDDS, mobile medical app regulation in the US	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published final guidances on the agency’s regulatory approach to medical device data systems (MDDS) and mobile medical technologies that pose low risk to patients an...
Feb 5, 2015	British regulators launching online registration system for Class I devices	By Stewart Eisenhart, Emergo Group The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on Febr...
Jan 30, 2015	Key changes to South Korean KGMP, IVD regulations set for 2015	South Korean medical device regulators will implement significant changes affecting compliance requirements for in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015. ...
Jan 26, 2015	ANVISA granted more leverage to prioritize medical device-related health risks	By Stewart Eisenhart, Emergo Group A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Braz...
Jan 23, 2015	Russian regulators publish new medical device nomenclature system	By Stewart Eisenhart, Emergo Group Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types. The categories (link in Russian) appear to be ba...
Jan 21, 2015	Health Canada calls for MDSAP participants	By Stewart Eisenhart, Emergo Group Canadian medical device market regulators have begun soliciting manufacturers to participate in a pilot version of a nascent international quality management system auditing program, the Medical Device Sin...
Jan 12, 2015	COFEPRIS adds hundreds of devices to list of products requiring no registration in Mexico	By Stewart Eisenhart, Emergo Group Mexican regulators have expanded their list of healthcare products that do not require registration and approval to be sold in the country. COFEPRIS, Mexico’s medical device market regulator, added 573 ite...
Jan 12, 2015	Indian Medical Device Regulation Changes in 2015?	By Stewart Eisenhart, Emergo Group India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015. The proposed Drugs and Cosm...
Jan 9, 2015	FDA’s new guidance database now online	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has formally launched a new database compiling all guidance documents pertinent to medical device manufacturers with ...
Jan 7, 2015	Colombian regulator lists additional products to be registered as medical devices	By Stewart Eisenhart, Emergo Group INVIMA, Colombia’s medical device market oversight agency, has added several “soft line” products to the list of medical devices that require registration in order to be legally sold in the country. Produc...
Dec 30, 2014	Chinese regulators agree to accelerated market access for US medical devices	By Stewart Eisenhart, Emergo Group Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago. According to US representatives at the 25th US-China J...
Dec 29, 2014	Japan’s PMDA now offers pre-consultations for medical device registrants	By Stewart Eisenhart, Emergo Group In conjunction with the recent implementation of the Pharmaceutical and Medical Device Law (PMDL), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their...
Dec 22, 2014	New law boosts Health Canada’s powers over medical device safety	By Stewart Eisenhart, Emergo Group A new law implemented in Canada, the Protecting Canadians from Unsafe Drugs Act, has expanded Health Canada’s oversight of the country’s medical device market in an effort to bring Canadian patient safety ...
Dec 17, 2014	Indian authorities scrutinizing medical device pricing practices	By Stewart Eisenhart, Emergo Group The Indian government has begun requesting pricing data from medical device and pharmaceutical product manufacturers in order to more tightly monitor extreme, potentially illegal price variations. The gove...
Dec 13, 2014	With 3D Printing, Medical Devices Are Cool Again	Dr. Michael Patton Contributor Editor’s note: Dr. Michael Patton is co-founder and CEO of Texas-based Medical Innovation Labs. The recent and successful human implantation of a 3D-printed vertebra at Peking University in China captured the ...
Dec 8, 2014	Indian regulators propose changes to good manufacturing practice requirements for medical devices	By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) has proposed bringing the country’s Good Manufacturing Practice requirements for medical and in vitro diagnostic devices more in line with those ...
Dec 1, 2014	South Korean medical device regulators ban some raw materials	By Stewart Eisenhart, Emergo Group South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production. According to Article 5 of the amended MFDS regulation, the following...
Nov 21, 2014	US FDA delays UDI compliance deadline for some single-use implantable devices	By Stewart Eisenhart, Emergo Group Medical device regulators in the US have extended their Unique Device Identification compliance deadline to September 24, 2016 for some implantable medical devices to provide more time for manufacturers of...
Nov 20, 2014	Australia and New Zealand abandon plan for single medical regulatory agency	By Stewart Eisenhart, Emergo Group The governments of Australia and New Zealand no longer plan to form a joint regulatory authority to oversee both countries’ medical device markets. According to a joint statement by the countries’ health m...
Nov 20, 2014	ANVISA to allow medical device firms to evaluate their inspections	By Stewart Eisenhart, Emergo Group Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes. Firm...
Nov 17, 2014	New electronic formatting requirements in Canada for Class III and IV MDL applications	By Stewart Eisenhart, Emergo Group Canada’s medical device market regulator Health Canada has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to tak...
Nov 11, 2014	Major changes to medical device registration process in Japan	By Stewart Eisenhart, Emergo Group Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According t...
Nov 7, 2014	ANVISA allowing automatic deadline extensions for medical device registrants	By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has begun allowing automatic extensions for deadlines for market registrants to comply with new requirements issued by the regulator. ANVISA’s new service o...
Oct 24, 2014	Apple bars medical app developers from using iCloud	By Stewart Eisenhart, Emergo Group As many mobile medical application developers are aware, Apple has amended its App Store Review Guidelines to forbid apps available through the firm’s HealthKit framework from storing users’ health data on...
Oct 21, 2014	Australia moves ahead with loosening standards for domestic device registration	By Stewart Eisenhart, Emergo Group The Australian Department of Health has published additional details on the government’s plan to allow domestic medical device manufacturers to leverage CE Marking for faster registration in their home mar...
Oct 20, 2014	Australian government proposes bypassing TGA for medical devices with CE Marking	By Stewart Eisenhart, Emergo Group The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from...
Sep 4, 2014	Brazilian medical device regulators take first steps toward electronic registration system	By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has announced plans to implement a system for electronic submission of registration applications based on guidelines from the International Medical Device ...
Aug 29, 2014	Further analysis of China’s new IVD registration rules	By Stewart Eisenhart, Emergo Group Emergo colleagues in China have provided additional analysis of new requirements from the China Food and Drug Administration (CFDA) regarding in vitro diagnostic (IVD) device registrations. According to CF...
Aug 27, 2014	Australian TGA taking a more discerning approach to notified bodies	By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessm...
Aug 22, 2014	Australian TGA taking a more discerning approach to notified bodies	By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessm...
Aug 20, 2014	FDA pilot program for medical device review tool development in the works	By Stewart Eisenhart, Emergo Group A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications. According to new guid...
Aug 18, 2014	US regulators to exempt some Class I and II medical devices from 510(k) premarket review	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness....
Aug 12, 2014	Further analysis of new Chinese medical device registration requirements	By Stewart Eisenhart, Emergo Group Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA Administrative O...
Aug 6, 2014	New Chinese medical device, IVD regulations take effect in October 2014	By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have published long-awaited updates to medical device as well as in vitro diagnostic device and labeling requirements that will go into force October 1, 2014. First...
Aug 5, 2014	Revised medical device definitions implemented in New Zealand	By Stewart Eisenhart, Emergo Group New Zealand medical device and drug market authority Medsafe has updated its process for defining medical devices and pharmaceutical products as part of an ongoing merger with the Australian Therapeutic Go...
Aug 1, 2014	Japanese regulators announce enforcement date for new medical device and drug laws	By Stewart Eisenhart, Emergo Group The Japanese government has set an enforcement date (link in Japanese) of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets. The revised Pharmaceutica...
Jul 30, 2014	US legislators again propose broader Medicare coverage for telehealth	By Stewart Eisenhart, Emergo Group For the second time in two years, members of the US House of Representatives have drafted legislation to expand reimbursement of mobile medical technologies used for remote patient monitoring under the Med...
Jul 28, 2014	European regulators issue guidance on nanotechnology in medical devices	By Stewart Eisenhart, Emergo Group The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devic...
Jul 23, 2014	Russian regulators preparing new medical device classification system?	By Stewart Eisenhart, Emergo Group Roszdravnadzor, the Russian medical device market regulator, has announcedplans (link in Russian) to develop a new device classification system based on Global Medical Device Nomenclature (GMDN), suggestin...
Jul 21, 2014	Malaysian medical device regulators change requirements for docs, AI requests	By Stewart Eisenhart, Emergo Group Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country. ...
Jul 21, 2014	US FDA publishes insight into 510(k) Substantial Equivalence determination process	By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determ...
Jul 18, 2014	Indian regulators clarify requirements for medical device registrations, clinical trials	By Stewart Eisenhart, Emergo Group New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device re...
Jul 12, 2014	Malaysian medical device regulators change requirements for DoCs, AI requests	By Stewart Eisenhart, Emergo Group Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country. ...
Jul 9, 2014	COFEPRIS seizures demonstrate importance of proper medical device labeling in Mexico	By Stewart Eisenhart, Emergo Group Mexican medical device market regulator COFEPRIS has recently confiscated 23,000 medical devices due to improper labeling, according to Emergo Group sources in Mexico City. Specifically, the devices were s...
Jul 1, 2014	Health Canada to follow IMDRF unique device identification framework	By Stewart Eisenhart, Emergo Group Canadian medical device market regulators have issued a draft notice on plans to implement a national Unique Device Identification (UDI) system based solely on guidelines developed by the International Med...
Jun 30, 2014	U.S. FDA relaxes regulatory requirements for medical device data systems	By Stewart Eisenhart, Emergo Group Medical device data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration’s regulatory controls, according to new guidance...
Jun 23, 2014	US FDA outlines plans for device review process improvements	By Stewart Eisenhart, Emergo Group Following third-party process improvement recommendations issued in late 2013, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has laid out a two-stage plan to imple...
Jun 20, 2014	Malaysian medical device market regulators clarify, expand policies	By Stewart Eisenhart, Emergo Group Medical device market regulators in Malaysia have implemented several new policiespertaining to the country’s recently enacted Medical Device Act. Recent Medical Device Authority (MDA) policies target five...
Jun 17, 2014	ANVISA proposing eased registration for lower-risk medical devices	By Stewart Eisenhart, Emergo Group Brazilian medical device market regulators have initiatedpublic consultations on proposals that could significantly reduce registration and re-registration requirements for Class I and II devices. At a mee...
Jun 10, 2014	IVD reagents to be regulated as medical devices in South Korea	By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) plans to begin regulating in vitro diagnostic (IVD) reagents as medical devices instead of pharmaceutical products beginning in November 2014. Accor...
Jun 6, 2014	Updated ISO 13485 Requirements from Egyptian Ministry of Health	By Stewart Eisenhart, Emergo Group Egyptian medical device market regulators at the Central Administration of Pharmaceutical Affairs (CAPA) will soon require the latest version of the ISO 13485 standard for quality system compliance, Emergo...
Jun 4, 2014	Expedited COFEPRIS registration planned for South Korean medical devices	By Stewart Eisenhart, Emergo Group Medical devices registered for sale in South Korea are expected to soon have expedited access to the Mexican market. Emergo Group has learned that Mexican and South Korean regulators have formed an agreeme...
Jun 4, 2014	EN 60601-1 3rd Edition electrical standard now harmonized in Europe	By Stewart Eisenhart, Emergo Group European Union regulators have now fully recognized the most recent version of the EN 60601 electrical safety standard, EN 60601-1 3rdEdition, to the European Union’s Medical Devices Directive (MDD). The E...
Jun 3, 2014	Mexican regulators clarify stance on importation of medical devices during renewal periods	By Stewart Eisenhart, Emergo Group Mexico’s medical device market regulator COFEPRIS has officially notified the country’s Custom officers to allow importation of medical devices whose registration renewal applications are still being proce...
May 30, 2014	US FDA scrutinizing 3-D printing for medical devices	By Stewart Eisenhart, Emergo Group US medical device market regulators are putting the burgeoning practice of 3-D printing for medical devices under the microscope, having announced a public workshop on the issue in October 2014 at the Food...
May 28, 2014	New FDA information on UDI rule exceptions available	By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published new online information explaining allowable exceptions and compliance deadline extensions medical device manufacturers may request regarding the agency’s n...
May 6, 2014	April 2014 Medical device recalls \| Medtech regulatory news for the week of May 5, 2014	Medical device recalls for April 2014 May 2, 2014 by Arezu Sarvestani April Summary Class I recalls: 7 Class II recalls: 203 Class I recalls Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall Draeger Medical Systems;...
May 1, 2014	Medical device regulatory changes in China: Emergo group analysis	By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) recently announced significant changesto its regulatory system for medical devices. Revised regulations will go into effect on June 1, 2014, affecting areas in...
Apr 30, 2014	South African regulators publish draft medical device and IVD regulation	By Stewart Eisenhart, Emergo Group The South African Department of Health has published draft regulations for the country’s medical and in vitro diagnostic (IVD) device market for a three-month public comment period. The proposed regulation...
Apr 24, 2014	FDA offers expedited U.S. market pathway for some high-risk devices	By Stewart Eisenhart, Emergo Group A new proposal by the US Food and Drug Administration would allow faster market authorization for some high-risk medical devices targeting diseases that cannot be treated by current approved technologies. ...
Apr 22, 2014	Endo Health warned by FDA on AMS pelvic mesh plant \| Medtech regulatory news for the week of Apr. 21, 2014	FDA warns Endo Health on AMS pelvic mesh plant April 17, 2014 by Brad Perriello Endo Health Solutions said the FDA warned it about procedural violations at a Minnesota plant run by its American Medical Systems subsidiary that makes pelvic m...
Apr 15, 2014	Analogic won 510(k) clearance from FDA for handheld Sonic Window ultrasound device \| Medtech regulatory news for the week of Apr. 14, 2014	Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound April 9, 2014 by Brad Perriello Analogic said it won 510(k) clearance from the FDA for its handheld Sonic Window ultrasound device, designed to help caregivers view t...
Apr 15, 2014	In brief: Health Canada updates medical device license application forms	By Stewart Eisenhart, Emergo Group Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants. Manufacturers and sponsors seeking MDLs for Class II, III or IV devices should be...
Apr 14, 2014	Health Canada Inspection Report: High CMDR compliance rates for medical device establishment license holders	By Stewart Eisenhart, Emergo Group A new Health Canada report on regulatory inspections of domestic and foreign medical device companies active in the Canadian market has shown a 98% overall compliance rate among importers, manufacturers an...
Apr 11, 2014	September 2014 compliance deadline for Indian medical device labeling rules	By Stewart Eisenhart, Emergo Group India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014. The Drugs Controller Gener...

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FAQ about Emergo Group

When was Emergo Group founded?

Emergo Group was founded in 1997.

What has the press written about Emergo Group?

Parsers VC has collected 347 articles mentioning Emergo Group, among them “bb7 expands into new territory” (Jul 14, 2015) and “Peruvian regulators place new requirements on medical devices with PVC components” (Jun 15, 2015).

Is Emergo Group still active?

Yes, Emergo Group is active; its latest activity on Parsers VC dates from Mar 3, 2017.