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External news

More Details on Changes to China FDA Medical Device Clinical Requirements

Emergo Group Blog - Fri, 11/17/2017 - 16:24
EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration (CFDA) has published new technical guidance on accepting medical device clinical data from sources outside China. Foreign clinical data used in CFDA registration applications must meet China Good Clinical Practice requirements. Chinese market registrants should notify CFDA before submitting applications that they intend to use foreign clinical data in their applications.

Encryption, FIPS 140 and Medical Devices: Frequently Asked Questions

Emergo Group Blog - Fri, 11/10/2017 - 19:17
EMERGO SUMMARY OF KEY POINTS: Pressure from US regulators and healthcare purchasing organizations for medical devices to demonstrate adequate encryption capabilities is increasing. Compliance with the Federal Information Publications Standard (FIPS) 140-2 standard enables manufacturers to demonstrate adequate encryption tools for their devices. FIPS 140-2 compliance is best addressed early in the medical device design phase.

Brazil’s ANVISA Proposing Easier Market Pathway for Low-risk Medical Devices and IVDs

Emergo Group Blog - Fri, 11/10/2017 - 17:21
EMERGO SUMMARY OF KEY POINTS: Brazil’s ANVISA plans to replace cadastro registration requirements for Class I medical devices and IVDs with a notification system for faster market access. Class I devices undergoing notification instead of cadastro review would bypass technical analysis. Additional public consultations and regulations will need to be published before ANVISA’s notification system comes into force.

MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices?

Emergo Group Blog - Tue, 11/07/2017 - 20:24
EMERGO SUMMARY OF KEY POINTS Low-risk medical device manufacturers may now choose between Medical Device Market Application (MDMA) and Medical Device National Registry (MDNR) registration pathways in Saudi Arabia. The SFDA’s MDNR route is faster, but some Class I non-sterile, non-measuring device manufacturers may still benefit more by undergoing MDMA registration.

China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements

Emergo Group Blog - Mon, 11/06/2017 - 17:07
EMERGO SUMMARY OF KEY POINTS: CFDA has proposed adding more Class II and III medical devices and IVDs to its clinical trial exemption list. The regulator has already exempted more than 300 Class II and about 100 Class III devices from clinical trial requirements. CFDA registrants qualifying for these exemptions may submit clinical data obtained outside China for market application purposes.

Health Canada Pushes for Reduced MDSAP Audit Timeframes

Emergo Group Blog - Wed, 11/01/2017 - 15:19
EMERGO SUMMARY OF KEY POINTS: Medical Device Single Audit Program (MDSAP) audit timeframes have been reduced in response to industry feedback received by Health Canada. MDSAP audit time reductions will primarily target smaller medical device companies with limited regulatory compliance resources. All MDL holders active in the Canadian market will have to comply with MDSAP by early 2019.

Final FDA Guidance on When Medical Device Changes Require New 510(k) Submissions

Emergo Group Blog - Mon, 10/30/2017 - 21:00
EMERGO SUMMARY OF KEY POINTS: US FDA has issued final guidance documents for changes to medical device hardware and software that require new 510(k) applications. The final guidances do not differ substantially from draft versions published in 2016.

How Europe Plans to Address Orphaned Medical Device Manufacturers and NB De-notification

Emergo Group Blog - Thu, 10/26/2017 - 22:56
EMERGO SUMMARY OF KEY POINTS: European Member States have adopted a procedure for “orphaned manufacturers” that the Dutch Competent Authority IGJ has implemented already. Manufacturers who are affected by the scope reduction of their Notified Bodies can be eligible for a “period of grace.” Application needs to be submitted in the European Member State where the manufacturer or AR is based. NANDO has been updated with AIMD, IVDD and MDD scopes of NBs.

How Europe Plans to Address Orphaned Medical Device Manufactures and NB De-notification

Emergo Group Blog - Thu, 10/26/2017 - 22:56
EMERGO SUMMARY OF KEY POINTS: European Member States have adopted a procedure for “orphaned manufacturers” that the Dutch Competent Authority IGJ has implemented already. Manufacturers who are affected by the scope reduction of their Notified Bodies can be eligible for a “period of grace.” Application needs to be submitted in the European Member State where the manufacturer or AR is based. NANDO has been updated with AIMD, IVDD and MDD scopes of NBs.

US FDA Rolls out New Market Pathway for Breakthrough Medical Devices

Emergo Group Blog - Thu, 10/26/2017 - 14:32
EMERGO SUMMARY OF KEY POINTS: The US FDA is launching a new expedited registration route for breakthrough and innovative medical devices. The Breakthrough Devices Program covers qualifying 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications. The program entails earlier interactions between regulators and manufacturers during product development.

ANVISA Provides More Details on New Brazilian GMP Inspection Regime

Emergo Group Blog - Tue, 10/24/2017 - 15:37
EMERGO SUMMARY OF KEY POINTS: Brazil’s ANVISA has published a new regulation to clarify changes to its Brazil GMP inspection and certification process. The regulation, RDC 183/2017, explains which documents are required for BGMP certification as well as which types of establishments that must obtain BGMP certification in Brazil. Applicants that submitted inspection requests before the new BGMP certification process was announced will have 60 days to file amendments to ANVISA to qualify for the new approach.

New European Notified Body Product Codes Open for Consultation

Emergo Group Blog - Thu, 10/19/2017 - 15:31
EMERGO SUMMARY OF KEY POINTS: The first implementing act related to the Regulations for Medical Devices and IVDs is now open for consultation. The significantly changed list of product codes for IVDs is heavily discussed and it is not certain this list will be the final version. The high level of granularity in these tables may complicate audits.

Health Canada Proposing Major Fee Increases for Medical Device License Applications

Emergo Group Blog - Tue, 10/17/2017 - 22:05
EMERGO SUMMARY OF KEY POINTS: Health Canada wants to implement Medical Device License application fee increases for Class II, III and IV medical device registrants. MDL fees have not been significantly adjusted since 2011, according to Health Canada. If implemented, these major MDL fee increases could complicate Canadian market entry for many medical device companies.

Medical Device Cybersecurity Legislation Advances in US Congress

Emergo Group Blog - Fri, 10/13/2017 - 21:44
EMERGO SUMMARY OF KEY POINTS: New legislation introduced in the US House of Representatives would launch a working group headed by the FDA to develop strategies for mitigating cybersecurity risks in medical technology. The proposed legislation builds on recommendations issued by the Health Care Industry Cybersecurity Task Force earlier in 2017. If passed by the full Congress, the legislation would require the FDA-led working group to report on its efforts within 18 months.

ANVISA Officially Publishes Brazilian GMP Certification Process Changes

Emergo Group Blog - Fri, 10/13/2017 - 16:12
EMERGO SUMMARY OF KEY POINTS: Brazil’s ANVISA has published updated BGMP certification rules allowing for desktop reviews instead of on-site inspections. The new BGMP requirements apply to Class III and IV device registrants able to provide adequate technical documentation for review. A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work.

Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices

Emergo Group Blog - Thu, 10/12/2017 - 22:00
EMERGO SUMMARY OF KEY POINTS: The Saudi Food and Drug Authority (SFDA) has officially announced a new market pathway for Class I non-sterile, non-measuring devices that does not require Medical Device Marketing Authorization (MDMA). Qualifying low-risk device manufacturers may list their products in the Saudi Medical Device National Registry (MDNR) in lieu of MDMA premarket review. Implementation timeframes for the new non-MDMA market pathway have not yet been disclosed.

Changes to Australian Medical Device Recall Process Set for Early 2018

Emergo Group Blog - Mon, 10/09/2017 - 21:52
EMERGO SUMMARY OF KEY POINTS: Updates to the Australian TGA’s medical device recall process will come into effect in January 2018. The updated TGA recall process includes guidelines for determining recall versus non-recall actions. TGA registrants should take advantage of a “familiarization period” between now and the recall updates’ effective date of January 15, 2018.

New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements

Emergo Group Blog - Thu, 10/05/2017 - 20:32
EMERGO SUMMARY OF KEY POINTS: The US FDA has a new guidance out that includes a FAQ on MDUFA IV user fees and refund policies for de novo medical device premarket submissions. Only de novo devices intended for pediatric applications and those submitted by government entities and not intended for commercialization will be exempt from user fees. Because new user fees are substantial, de novo device applicants should carefully consider FDA policies described in the guidance.

MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews

Emergo Group Blog - Wed, 10/04/2017 - 17:18
EMERGO SUMMARY OF KEY POINTS: US FDA has published performance goals for handling de novo medical device submissions. De novo user fees and performance goals were established under the Medical Device User Fee Amendments of 2017 (MDUFA IV). FDA has set a 150-day timeframe for review of de novo applications.

IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions

Emergo Group Blog - Tue, 10/03/2017 - 20:35
EMERGO SUMMARY OF KEY POINTS: The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on recommendations for assessing usability of medical device registry data by regulatory agencies. IMDRF identifies four key factors agencies should consider when determining the usability of a device registry’s data in making regulatory decisions. IMDRF is accepting comment on its proposal until December 1, 2017.

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