Meet Regulatory Solution : Worldwide Medical Device Regulatory Updates

Sunday, 13 July 2014

Worldwide Medical Device Regulatory Updates

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.

COFEPRIS Seizures Demonstrate Importance of Proper Medical Device Labeling in Mexico

July 7, 2014 by Stewart Eisenhart

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 seized for noncompliance with Mexican labeling norm NOM-137-SSA1-2008 requirements. Violations included:

Health Canada to Follow IMDRF Unique Device Identification Framework

June 27, 2014 by Stewart Eisenhart

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 Medical Device Regulators Forum (IMDRF). Health Canada states that it does not plan to add any additional UDI requirements specific to the Canadian market “at this time,” relying completely on the IMDRF UDI Working Group’s finalized guidance issued in December 2013.

US FDA Relaxes Regulatory Requirements for Medical Device Data Systems

June 26, 2014 by Stewart Eisenhart

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 from the agency.

Medical Device Establishment Licensing Rules Set to Take Effect in Malaysia

June 20, 2014 by Stewart Eisenhart

Requirements that medical device companies based in Malaysia obtain establishment licenses will come into force on June 30, 2014. Following that deadline, any medical devie manufacturer, authorized representative or distributor that has not either obtained or applied for a device license may not conduct medical device-related business in Malaysia.

US FDA Outlines Plans for Device Review Process Improvements

June 19, 2014 by Stewart Eisenhart

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 implement those changes for medical device reviews.

Malaysian Medical Device Market Regulators Clarify, Expand Policies

June 12, 2014 by Stewart Eisenhart

Medical device market regulators in Malaysia have implemented several new policies pertaining to the country’s recently enacted Medical Device Act. According to Emergo Group’s Kuala Lumpur office, recent Medical Device Authority (MDA) policies target five key areas: authorized representation, Conformity Assessments, registration exemptions, export/import requirements and Good Manufacturing Practice (GMP) certifications for establishment licensing. Authorized representation

ANVISA Proposing Eased Registration for Lower-Risk Medical Devices

June 11, 2014 by Stewart Eisenhart

Brazilian medical device market regulators have initiated public consultations on proposals that could significantly reduce registration and re-registration requirements for Class I and II devices.

IVD Reagents to be Regulated as Medical Devices in South Korea

June 9, 2014 by Stewart Eisenhart

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.

In Brief: Updated ISO 13485 Requirements from Egyptian Ministry of Health

June 4, 2014 by Stewart Eisenhart

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 Group’s Cairo office has learned. Medical device manufacturers selling in Egypt will have a six-month grace period before CAPA begins requiring ISO 13485:2012 compliance for registrations and importation. Stewart Eisenhart

EN 60601-1 3rd Edition Electrical Standard Now Harmonized in Europe

June 2, 2014 by Stewart Eisenhart

European Union regulators have now fully recognized the most recent version of the EN 60601 electrical safety standard, EN 60601-1 3rd Edition version 3.1, to the European Union’s Medical Devices Directive (MDD). The EN 60601-1 standard was actually released 13 July 2013 under the common designation of Edition 3.1, that has been harmonized under the MDD.

Expedited COFEPRIS Registration Planned for South Korean Medical Devices

May 30, 2014 by Stewart Eisenhart

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 agreement (link in Spanish) that would ease market entry into Mexico for devices holding Korean Ministry of Food and Drug Safety (MFDS) registrations. Similar agreements between Mexican regulator COFEPRIS and the US Food and Drug Administration, Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency are already in place.

Mexican Regulators Clarify Stance on Importation of Medical Devices during Renewal Periods

May 23, 2014 by Stewart Eisenhart

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 processed. According to Emergo Group’s Mexico City office, COFEPRIS will allow importation of medical devices if manufacturers have submitted their registration renewal applications on time (150 days prior to registration expiration date) and have yet to receive responses from the regulator.

US FDA Scrutinizing 3-D Printing for Medical Devices

May 23, 2014 by Stewart Eisenhart

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 and Drug Administration’s headquarters.

New FDA Information on UDI Rule Exceptions Available

May 20, 2014 by Stewart Eisenhart

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 new Unique Device Identification (UDI) requirements.

In Brief: Online IVD Registration Pathway Announced for Malaysian Market

May 12, 2014 by Stewart Eisenhart

Malaysian medical device regulators now offer online registration for in vitro diagnostic (IVD) device manufacturers. The Malaysian Medical Device Authority has built in support for IVD registrations to its Medical Device Centralised Application System (MEDCAST) online application system, as well as issued new guidelines on a 12-step registration process for IVDs.

Health Canada: DuPont Packaging Material Changes to Impact Sterile Medical Device Manufacturers

May 9, 2014 by Stewart Eisenhart

Medical device manufacturers licensed to sell their products in Canada have been notified that recent changes in the production process of a widely used device packaging material will require some firms to file significant change amendments with Health Canada, Emergo Group has learned. Health Canada’s notice to Medical Device License (MDL) holders relates to recent manufacturing changes implemented by DuPont for that firm’s Tyvek® packaging material; Tyvek is used extensively for sterile medical device packaging. Impact on Class III and IV devices

US FDA Seeking Participants for 510(k) eSubmission Pilot

May 2, 2014 by Stewart Eisenhart

US medical device market regulators have begun accepting requests for participation in a pilot of their upcoming electronic submission program for 510(k) premarket notification applications.

South African Regulators Publish Draft Medical Device and IVD Regulation

April 29, 2014 by Stewart Eisenhart

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 regulations would fall under South Africa’s Medicines and Related Substances Act of 1965, which would grant the health ministry’s Medicines Control Council the authority to oversee medical device and IVD registrations. Classification

Medical Device Regulatory Changes in China: Emergo Group Analysis

April 28, 2014 by Stewart Eisenhart

The China Food and Drug Administration (CFDA) recently announced significant changes to its regulatory system for medical devices. Revised regulations will go into effect on June 1, 2014, affecting areas including new clinical trial requirements, Class I device reviews and registration validity timeframes. Based on a careful Emergo Group analysis of the CFDA’s revisions, we’ve identified several key areas that will impact medical device registrations in China.

FDA Offers Expedited US Market Pathway for Some High-risk Devices

April 22, 2014 by Stewart Eisenhart

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.

Health Canada Inspection Report: High CMDR Compliance Rates for Medical Device Establishment License Holders

April 10, 2014 by Stewart Eisenhart

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 and distributors. Health Canada inspected a total of 2057 Medical Device Establishment License (MDEL) holders over the course of the regulator’s 2012-2013 fiscal year, citing 3251 observations of noncompliance with various sections of the Canadian Medical Device Regulations. Most common observations cited involved documentation issues (section 45(g) of the CMDR); recall procedures (section 58(b)); and investigation procedures (section 58(a)).

September 2014 Compliance Deadline for Indian Medical Device Labeling Rules

April 9, 2014 by Stewart Eisenhart

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 General’s (India) Central Drugs Standard Control Organization (CDSCO) currently requires “India-specific” labeling to be attached to imported devices at their Indian ports of entry by distributors. India-specific labeling information should include importer and/or distributor names and Import License numbers.

Draft FDA Report Proposes US Health Technology Framework

April 8, 2014 by Stewart Eisenhart

A new draft report by the US Food and Drug Administration proposes establishing a nationwide framework for regulating health information technology and medical devices. The FDA’s new proposals would involve three federal agencies (The FDA, Federal Communications Commission and the Office of the National Coordinator for Health Information Technology) in oversight of mobile medical apps and related technologies, and are intended to coordinate the roles of those regulators.

In Brief: Health Canada Updates Medical Device License Application Forms

April 3, 2014 by Stewart Eisenhart

Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.

New Regulation in Brazil Changes Enforcement of BGMP Requirements for Certain Medical Devices

April 1, 2014 by Stewart Eisenhart

The Brazilian government has implemented a new regulation, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for certain low-risk medical devices and IVDs.

In Brief: New Medical Device Regulation Published in China

March 31, 2014 by Stewart Eisenhart

Emergo Group’s Beijing office reports that the Chinese government has published a new Medical Device Supervision Management Regulation (link in Chinese) covering the country’s medical device regulatory system. The new regulation will go into force June 1, 2014. Emergo Group is currently studying the new document to determine its impact on medical device manufacturers selling in the Chinese market. We will provide further analysis in the next issue of RADAR.

In Brief: New Blue Guide from European Regulators

March 31, 2014 by Stewart Eisenhart

The European Commission has published its latest “Blue Guide” covering all products subject to the European Union’s New Legislative Framework, including medical devices, IVDs and active implantable devices. Emergo Group consultants in the US and Europe will be performing an extensive review of the new Blue Guide over the next several days, and will provide additional analysis of how medical device manufacturers will be impacted.

Training for Costa Rican Digital Medical Device Registration Pathway Announced

March 31, 2014 by Stewart Eisenhart

Costa Rican medical device regulators are preparing a system to facilitate online registration of medical devices in a move to drive up foreign manufacturers’ interest in the Central American market. The Costa Rican Ministry of Health has now published training materials for digital medical device registration, and is also conducting training sessions (link in Spanish) to explain the new process.

Medium Risk Medical Devices Subject to MDMA Registration in Saudi Arabia by December 31, 2014. IVDs in 2015.

March 31, 2014 by Stewart Eisenhart

The Kingdom of Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has announced when medical device manufacturers must secure valid Medical Device Marketing Authorizations (MDMA) to legally continue selling their products in the KSA.

Japanese Regulators Plan Faster Medical Device Registration Process

March 28, 2014 by Stewart Eisenhart

A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system. According to Emergo Group’s Tokyo office, the changes include both high-level amendments to Japan’s Pharmaceutical Affairs Law (PAL) applicable to both medical devices and drugs, and also measures specifically geared toward medical devices.

FDA Report: US Medical Device Recalls Up nearly 100% since 2003

March 25, 2014 by Stewart Eisenhart

A new report by the US Food and Drug Administration shows a 97% increase in recalls of medical devices between 2003 and 2012 due to stepped up public safety efforts by both regulators and industry. The agency attributes its findings to improved incident reporting primarily among manufacturers of radiological devices and by firms previously cited for 21 CFR Part 806 observations.

FDA No Longer Notarizing CDRH Export Certificates

March 18, 2014 by Stewart Eisenhart

The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.

Korean Regulators Waive Registration Requirements for Some Mobile Medical Devices

March 18, 2014 by Stewart Eisenhart

The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products—including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.

US FDA Considering New Requirements for Off-Label Use Data

March 6, 2014 by Stewart Eisenhart

US regulators have published updated draft guidance addressing distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.

US FDA Updates Electronic System for Medical Device Exporters

February 26, 2014 by Stewart Eisenhart

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has updated its voluntary electronic system for requesting medical device export documents based on feedback from manufacturers and initial importers.

Chinese Medical Device Revisions Nearing Implementation

February 24, 2014 by Stewart Eisenhart

The Chinese government’s State Council Executive Committee has approved updates (link in Chinese) to the country’s medical device regulatory system, bringing the long-awaited revisions closer to actual implementation. The latest approval follows submission of proposed medical device regulatory revisions by the China Food and Drug Administration’s (CFDA) predecessor agency to China’s State Council Legislative Affairs Office in 2008. Among anticipated revisions:

US FDA Updates Guidance on Feedback Mechanisms for Medical Device Registrants

February 18, 2014 by Stewart Eisenhart

US medical device market regulators have updated guidance first issued in 2012 on the FDA’s Pre-Submission feedback program for medical device manufacturers undergoing Investigational Device Exemptions (IDE), Premarket Approval (PMA), 510(k) premarket notification or other premarket reviews. All current and new FDA avenues for applicants seeking agency feedback during their registration processes are now referred to as “Q-Subs” for more efficient agency tracking, and include the following methods:

Staff Changes at Indian Regulator Could Boost Review Processes in the Long Term

February 18, 2014 by Stewart Eisenhart

The Drugs Controller General of India (DCG(I)), India’s medical device and pharmaceutical market regulator, has appointed a new head of its Medical Device Division as well as a new Joint Drugs Controller, which could lead to more efficient registration processes in the country. First, Aseem Sahu has succeeded Dr. E. Reddy as head of DCG(I)’s Medical Device Division. In addition, Dr. V. G. Somani has been named Joint Drugs Controller at the Central Drugs Standard Control Organization’s head office in New Delhi.

Analysis of 24,000+ FDA 510(k) records reveals trends

February 14, 2014 by Chris Schorre

Clients often ask us how long it will take for their medical device 510(k) submission to clear. The short answer is: it depends. But that answer doesn’t really satisfy most people. A few years ago we decided to take a more scientific approach to the issue and started examining FDA data to see how long it really takes a 510(k) to be cleared by the FDA. This year, we updated our analysis of all medical devices cleared via the 510(k) process between 2006 and the end of 2013. You can read our full analysis of FDA 510(k) review times but here are some key takeaways:

US Lawmakers Seek Regulatory Exemptions for Some Mobile Medical Devices and Apps

February 13, 2014 by Stewart Eisenhart

Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration oversight.

China Announces Expedited Market Authorization for Innovative Medical Devices

February 13, 2014 by Stewart Eisenhart

The China Food and Drug Administration (CFDA) will launch an expedited registration process (link in Chinese) on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country. Devices must have patents or patents pending as well as “significant clinical value” in order to qualify for expedited review; foreign manufacturers must still provide all required technical information and documentation for Chinese medical device registration.

US Medical Device Regulator to Improve PMA, IDE Processes

February 6, 2014 by Stewart Eisenhart

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements. The CRDH’s plans were announced as part of the department’s 2014 Strategic Priorities, which also include “customer service” initiatives.

November Enforcement Date for New Pharmaceutical Affairs Law in Japan

February 5, 2014 by Stewart Eisenhart

Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations (link in Japanese) for medical devices and pharmaceutical products. The revised Pharmaceutical Affairs Law (PAL), renamed the Pharmaceutical and Medical Device Law, will include more aggressive safety requirements for registered devices and set up distinct Market Authorization Holder (MAH) authorized representative rules for foreign manufacturers.

New KSA Declaration of Conformity Requirements for Imported Medical Devices

February 3, 2014 by Stewart Eisenhart

The Saudi Food & Drug Authority (SFDA) began requiring foreign medical device manufacturers to provide Declaration of Conformity certificates for all shipments into the Kingdom of Saudi Arabia on January 3, 2014.

New Educational Material from US FDA on Unique Device Identification System

February 3, 2014 by Stewart Eisenhart

The US Food and Drug Administration has published new training material to help medical device manufacturers comply with new Unique Device Identification (UDI) requirements in the country. The FDA UDI system requires US medical device market registrants to set up and maintain accounts with a Global Unique Device Identification Database (GUDID). Once registrants have opened accounts, they can submit device identification information into the database according to FDA rules. UDI data entered into GUDID is publicly searchable.

Latest Guidance from US FDA: Computational Modeling, Devices using Animal Sources

January 28, 2014 by Stewart Eisenhart

The US Food and Drug Administration has released two new draft guidances for medical device manufacturers that either include computational modeling data in their registration applications or use animal-derived sources in their products.

Clarified Reclassification Rules from TGA for Implantable Devices

January 22, 2014 by Stewart Eisenhart

Australia’s Therapeutic Goods Administration (TGA) will allow registered manufacturers of partial knee, hip and shoulder implants to submit summary technical reports as part of their reclassification applications through June 30, 2014.

Peruvian Regulators Update Rules for Importing Unregistered Medical Devices

January 17, 2014 by Stewart Eisenhart

Medical device market regulators in Peru have set up new special permission requirements (link in Spanish) for importing medical devices that have not yet been registered for sale in the country. According to the new rules, Peruvian medical device market authority DIGEMID will allow importation of non-registered devices intended for research projects, training or show-room purposes, or upon justified request by a healthcare provider to treat an individual patient.

New INMETRO, IEC 60601 Requirements in Brazil

January 16, 2014 by Stewart Eisenhart

Brazilian regulators have issued new requirements under Normative Instruction 9/2013 that expand certification requirements for some electronic and other medical devices.

New Custom Device Exemption Guidance from US FDA

January 14, 2014 by Stewart Eisenhart

The US Food and Drug Administration has published draft guidance on how to comply with custom device exemption rules for products intended to treat extremely rare conditions or diseases. Custom device exemptions were originally laid out in the US Food, Drug and Cosmetics Act, and then changed under the Food and Drug Administration Safety and Innovation Act of 2012. The new guidance is meant to address ongoing questions regarding implementation of and compliance with the exemptions. The new guidance includes the following components:

US FDA Provides 510(k) Communication Timeline

January 6, 2014 by Stewart Eisenhart

The US Food and Drug Administration recently added a new timeline to its 510(k) premarket notification webpage that summarizes typical communications between agency reviewers and medical device applicants betweensubmission and final clearance.

IMDRF Targets Uniform Standards for Medical Device Auditors

January 3, 2014 by Stewart Eisenhart

The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.

US Medical Device Tax One Step Closer to Repeal

December 19, 2013 by Stewart Eisenhart

The US Senate has joined the House in approving a new federal budget that includes provisions to repeal the Medical Device Excise Tax (MDET). The budget bill has also been signed by President Obama following Congressional passage.

Chinese Regulators to Launch Simplified Registration Renewal Process in 2014

December 17, 2013 by Stewart Eisenhart

The China Food and Drug Administration (CFDA) implemented a simplified certification renewal process on January 1, 2014 for medical devices. With the exception of devices with major changes, manufacturers seeking to renew their medical device registrations in China will face fewer documentation requirements and potentially faster re-certifications.

US Medical Device Tax Back on the Chopping Block

December 16, 2013 by Stewart Eisenhart

Federal budget negotiations currently underway in the US Congress would rescind a controversial tax on medical device sales in the country. The much-maligned Medical Device Excise Tax (MDET) on 2.3% of medical device companies’ gross sales in the US would be repealed under a version of the Bipartisan Budget Act of 2013 already passed by the House of Representatives and now under consideration in the Senate.

Report Identifies Areas for Improvement in FDA Device Review Process

December 12, 2013 by Stewart Eisenhart

A new report commissioned by the US Food and Drug Administration identifies four broad areas where the regulator should improve its methods for clearing or approving medical devices for sale. Mandated by the Medical Device User Fee Act of 2012 (MDFUFA III) and issued by Booz Allen, the report targets decision making, technology training, metrics and standardization processes needed to boost efficiency of FDA 510(k) premarket notification and Premarket Approval (PMA) device reviews. Recommendations include:

Colombian Regulators Set August 2014 Deadline for Medical Device Registrations

December 6, 2013 by Stewart Eisenhart

Colombian medical device market regulator INVIMA has set a deadline of August 11, 2014 for registration of more than 30 types of medical devices previously exempt from market authorization requirements.

New Spanish Documentation Requirements for Argentina

December 3, 2013 by Stewart Eisenhart

New laws set to take effect in Argentina will require medical device manufacturers and importers to provide Installation, Maintenance and Service Manuals for their products only in Spanish to regulatory authority ANMAT, according to Emergo Group’s Buenos Aires office.

Medical Device Regulatory Reform Advances in Japan

December 2, 2013 by Stewart Eisenhart

Legal reforms affecting medical device regulation in Japan have passed the country’s Diet and are now published in the official Japanese gazette, bringing them closer to full enactment in Asia’s largest single medical device market. The Pharmaceutical Affairs Law (PAL) Reform Act (links to document in Japanese), introduced in mid 2013, will have the following broad effects on medical device manufacturers in Japan:

Update on US FDA Unique Device Identification Submission System

November 25, 2013 by Stewart Eisenhart

The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year. Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device

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