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Medical Device Blog – QA & Regulatory Updates from Emergo Group
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
CDRH 2012 Strategic Priorities: Familiar Themes
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Priorities, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.
First, the regulator plans to complete implementation of its “Total Product Lifecycle Approach,” which entails taking into account “all of the relevant information available to the Center, at any stage of a product’s life cycle to assure the safety, effectiveness, and quality of medical devices,” according to the CDRH. This goal includes the following efforts:
- Improving premarket reviews by better managing premarket review workloads; issuing proposed rules for when the CDRH could utilize clinical studies conducted in non-US markets; finalizing all guidances related to improving premarket programs; and evaluating CDRH staffing, infrastructure and policies related to medical software.
- Addressing globalization challenges by participating in the first meeting of Global Harmonization Task Force successor the International Medical Device Regulators Forum, and by taking part in at least two harmonization efforts with non-US regulatory authorities this year.
- Improve compliance capability by implementing “business-case-for-quality” initiatives such as best-quality manufacturing practices and determining further actions for 2013 as well.
Second, the CDRH plans to improve communication and transparency both among its internal staff and with various constituencies—patients, industry groups and health care providers.
- Externally, the CRDH will enhance information exchange capabilities, improve feedback gathering and also establish a national forum for discussions with constituents.
- Internally, standard operating procedures for information sharing among staff will be established.
Third, the CDRH intends to improve its workforce in terms of both employee education and satisfaction. For example, the division plans to launch its Experiential Learning Program (ELP) to improve staff knowledge of device design and manufacture, as well as its CDRH Leadership Enhancement and Development Program (LEAD) to improve managers’ and supervisors’ performance.
Fourth, the regulator plans to boost innovation to better meet public health needs as well as improve regulatory science.
- Supporting innovative device development through initiatives including the Entrepreneurs in Residence program and Innovation Pathway 2.0 this year.
- Developing personalized medicine programs by issuing guidance on Companion Diagnostics and co-development of drugs and devices.
- Improving regulatory science via establishment of public-private partnerships between FDA, industry and academia, and through expansion of computer modeling and simulation to support device development and regulation.
Markets: USATags: 510(k), 510k, CDRH, Center for Devices and Radiological Health, FDA, medical device, Premarket Review
Author: Stewart EisenhartDate: January 26, 2012
Mexico Expands Equivalency to Devices Registered in Japan
Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical devices registered in the US or Canada to some devices approved or certified for sale in Japan.
COFEPRIS equivalence will apply to devices classified as Class II, III or IV in Japan; products registered as Class I devices in Japan must still go through the standard registration process in Mexico.
Manufacturers of qualifying devices must have either approval issued by Japan’s Ministry of Health, Labor and Welfare (MHLW) or their certificates issued by a Registered Certification Body in Japan.
Some of the documents that manufacturers must also provide in order to qualify for expedited review in Mexico are:
- Operating license
- Notification of Exportation
- Original Certificate of Free Sale
- Original Letter of Representation
- Labels and Instructions for Use
The expanded Equivalency Agreement will go into effect February 24, 2012. Interest in the Mexican market has already increased over the past year due to expedited review options for manufacturers registered in the US and Canada; similar interest from medical device companies registered in Japan will no doubt also grow once the new agreement is implemented.
Markets: Japan, MexicoTags: COFEPRIS, equivalency agreement, Japan, medical device, Mexico, PMDA
Author: Stewart EisenhartDate: January 26, 2012
New Medical Device Regulations Imminent in Russia
Update 02/07/2012: We have been informed by our Moscow office that Russian authorities have postponed implementation of these regulations until June 2012.
Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks.
According to Emergo Group’s Moscow office, Roszdravnadzor and the Russian Ministry of Public Health are still negotiating aspects of the new regulations pertaining to clinical studies. But the new rules are anticipated to include the following components:
- Authorized Representation may be required and if so, the Authorized Representative role in Russia will resemble the European arrangement, and will serve as the liaison between manufacturers and Roszdravnadzor for all vigilance-related activities. (It remains unclear whether this requirement will actually go into effect.)
- Medical device vigilance requirements have been more clearly defined and delineated. Reporting timelines and post-approval reporting to Roszdravnadzor are expected to be part of these new requirements.
- Home country approval will be required across the board.
- Products classified as measuring devices will require additional certification. This requirement will also be retroactive, and will likely affect devices such as blood pressure monitors.
- Russia’s clinical trial process will become more formalized, requiring protocols, ethics committee reviews and patient agreements.
Once enacted, these new rules will significantly impact the Russian medical device registration process. We will provide updates as soon as we receive further details.
Markets: RussiaTags: authorized representation, authorized representative, medical device, Roszdravnadzor, Russia, Russian Federation
Author: Stewart EisenhartDate: January 25, 2012
US Government to Require Device Manufacturers to Disclose Payments to Doctors
The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.
According to a recent New York Times report (tiered subscription required), the new rules are designed to tackle influence these payments have on doctors’ treatment decisions; payment from a medical device manufacturer to a doctor has the potential to make it likelier that that doctor will prescribe that manufacturer’s device instead of cheaper alternatives, evidence suggests.
The new rules will require companies with at least one product covered by Medicare or Medicaid to disclose all payments to doctors who are not their own employees. Payment data they provide will be published online.
Types of payments falling under these requirements include compensation for development, assessment or promotion of new products as well as royalty payments to inventors, payments to teaching hospitals for research and even “$25 worth of bagels and coffee to a doctor’s office for a meeting.” Companies’ chief executives, chief financial officers and/or chief compliance officers must attest to each report’s accuracy.
Administration officials believe more than 1,100 firms will be impacted by the new rules; failure to comply will incur penalties of up to $10,000 for each payment a firm fails to disclose. Knowingly failing to report payments will incur penalties of up to $100,000 per violation, capped at $1 million per year.
The Centers for Medicare & Medicaid Services (CMS) is accepting public comment on the rules through February 17th, after which final rules will be implemented.
Markets: USATags: CMS, Medicaid, medical device, Medicare, new york times
Author: Stewart EisenhartDate: January 23, 2012
European Med-Tech Trade Groups Join Forces
European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a single industry trade federation to more effectively lobby on behalf of their medical device and IVD manufacturing members.
The associations will name a joint chief executive to oversee activities and develop organizational strategies; however, Eucomed and EDMA will continue to operate as separate legal entities. Furthermore, the new joint federation is open to membership for other European industry trade groups, as well.
A top priority in the short term for the federation will be cooperating with EU policymakers hammering out a new regulatory framework for medical devices.
Markets: EuropeTags: edma, EU, Eucomed, Europe, European Union, IVD, medical device
Author: Stewart EisenhartDate: January 18, 2012
Chinese Medical Technology Market Primed for 17% Growth According to Citigroup
A new Citigroup Global Markets report on China’s medical device and technology industries expects the market to reach $5 billion in 2012, due primarily to increased hospital purchasing budgets, government investments in hospital upgrades and expansion, and robust hospital construction cycles in China through 2015.
Citi surveyed 383 Chinese hospitals across 29 provinces, and examined 11 medical equipment segments such as Magnetic Resonance Imaging (MRI), ultrasounds, tomography devices and radiography devices.
Leading segments
The report identified MRI, computed tomography, color ultrasound and digital radiography as the largest medical device segments in China, with health growth prospects; black-and-white ultrasound device purchasing, on the other hand, is expected to decline going forward.
Market dominated by foreign manufacturers
The Citi report also found that multinational medical device manufacturers continue to dominate the Chinese market across 10 of the 11 segments examined. Only in the patient monitoring device sector do domestic firms outnumber foreign ones. This trend will likely continue, as well: more than 80% of hospital respondents to Citi’s survey indicated a preference for multinational medical equipment when it comes to purchasing. Foreign manufacturers with sizeable Chinese market share include GE, Phillips, Siemens, while the biggest domestic firms include Mindray, Wangdong and Aeon.
Mexico Updates Lists of Class Ia Devices, Third-Party Reviewers
Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in the regulator’s Official Diary.
According to Emergo Group sources in Mexico City, manufacturers whose devices qualify for Class Ia classification could face a much simpler registration process, but notification as well as Mexico Registration Holder representation will likely still be required for such products.
In addition, COFEPRIS has officially released a list of approved third-party reviewers for the standard medical device registration process. (This list has yet to be published in the Official Diary, however.)
We will keep you further informed of these changes as more details emerge from COFEPRIS.
Markets: MexicoTags: COFEPRIS, medical device, Mexico, mexico registration holder, mrh
Author: Stewart EisenhartDate: January 12, 2012
GAO Finds FDA Data on Pediatric Devices Lacking
A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use.
The FDA Amendments Act of 2007 (FDAAA), implemented in part to spur development of more medical devices to treat pediatric populations, requires the FDA to identify all devices labeled for use in pediatric patients, and provide annual reports to Congress on the numbers of such devices approved. Although the agency has the capability to identify pediatric devices in its existing internal tracking system, the GAO report contends that the capability has not been consistently used to do so. As such, the FDA’s data on pediatric devices is not reliable or timely, according to the GAO.
GAO reviewers identified 18 devices brought to market either via the FDA’s Humanitarian Device Exemption (HDE) or premarket approval (PMA) process since the FDAAA went into effect; but reviewers also found that indications for use statements for 72% of all devices approved via HDE or PMA had no patient-age-specific information, meaning that additional pediatric devices could be on the US market.
The GAO recommends more consistent use of existing electronic flagging capabilities by FDA personnel in order to better account for the amount of pediatric medical devices marketed in the US.
Markets: USATags: FDA, GAO, HDE, medical device, pediatric medical device, PMA
Author: Stewart EisenhartDate: January 10, 2012
