MedPharmPlast Europe

MedPharmPlast Europe is a sector group of EuPC created in 2014 by and for companies involved in the whole supply chain of plastic medical devices and pharmaceutical packaging in Europe

External news

US FDA Explainer: Microneedling Products as Medical Devices

Emergo Group Blog - Tue, 09/19/2017 - 18:09
EMERGO SUMMARY OF KEY POINTS: New US FDA guidance explains factors for determining if a microneedling product meets the definition of a medical device. Microneedling devices sold in the US typically lack predicate devices, making FDA classification of these products difficult. FDA encourages mirconeedling device manufacturers to pursue de novo registration if their devices are considered medical devices.

South Korean MFDS Revises Recently Enacted Medical Device Regulations

Emergo Group Blog - Mon, 09/18/2017 - 16:13
EMERGO SUMMARY OF KEY POINTS: The South Korean MFDS has updated medical device regulations covering premarket reviews, registrations and enforcement. MFDS is also seeking industry comment on a draft proposal updating medical device safety and adverse event reporting requirements.

Russian Regulators Amending Medical Device, IVD Registration Requirements

Emergo Group Blog - Wed, 09/13/2017 - 21:53
EMERGO SUMMARY OF KEY POINTS: Russian regulatory changes for medical device and IVD registrants are slated to take effect by late 2017. Roszdravnadzor (RZN) has proposed easing requirements for IVD registrations as well as certain changes to medical device registrations. Medical device registration changes pertaining to technical documentation and user’s manuals, however, would require additional RZN review under the proposed changes.  

US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices

Emergo Group Blog - Tue, 09/12/2017 - 00:47
EMERGO SUMMARY OF KEY POINTS: The US FDA is setting up a pilot program to make its Premarket Approval (PMA) review process for high-risk medical devices more efficient. The agency is seeking nine PMA applicants for participation in the program. The agency will consider PMA applicants for participation in the program starting in late September 2017.

Singapore HSA Clarifies Telehealth and Mobile Medical App Guidelines

Emergo Group Blog - Mon, 09/11/2017 - 19:01
EMERGO SUMMARY OF KEY POINTS: The Singapore Health Sciences Authority (HSA) has issued new clarification and an FAQ regarding how telehealth products and mobile medical apps are regulated in the country. HSA plans an immediate market access pathway for mobile medical apps that have already registered in the US, Canada, Australia, Europe and/or Japan. Singapore’s general regulatory approach to telehealth resembles that of the US FDA.

New FDA De Novo User Fees: Effects for cutting-edge medical device manufacturers

Emergo Group Blog - Thu, 09/07/2017 - 20:53
EMERGO SUMMARY OF KEY POINTS: New FDA user fees for de novo medical device registrations may impact some manufacturers’ plans for commercialization of novel and cutting-edge products in the US. Even small-business FDA user fees for de novo applications may prove too high for some prospective US medical device market registrants.

New CFDA Medical Device Classification Catalog May Require New Registrations in China

Emergo Group Blog - Wed, 09/06/2017 - 15:15
EMERGO SUMMARY OF KEY POINTS: A new China FDA classification catalog may require new registrations for some medical device market applicants. Changes in classification requirements in the new catalog may result in up-classification (and re-registration) of some Class I medical devices in China. The new classification catalog will be implemented on August 1, 2018.

UK Regulator Launches Interactive Guide to New European Medical Device, IVD Regulations

Emergo Group Blog - Fri, 09/01/2017 - 20:06
EMERGO SUMMARY OF KEY POINTS: A new interactive online guide from the UK MHRA provides high-level overviews of new European medical device and IVD regulations. The new guide should prove useful for CE Mark certificate holders has they prepare for full compliance with the Medical Devices Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

How to Qualify for 2018 FDA Small-Business Medical Device User Fees

Emergo Group Blog - Thu, 08/31/2017 - 21:52
EMERGO SUMMARY OF KEY POINTS: The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees. Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program. The guidance includes separate requirements for US-based and foreign medical device market applicants.

MDUFA IV: Most US FDA user fees for medical device companies jump 33% or more in 2018

Emergo Group Blog - Tue, 08/29/2017 - 20:46
EMERGO SUMMARY OF KEY POINTS: FDA user fees for the 2018 fiscal year have increased across all registration categories. 510(k) fee paid by companies that don't qualify for small business discount will more than double. Annual Establishment Registration fee increasing 37% with no discount for small businesses.

In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

Emergo Group Blog - Mon, 08/28/2017 - 23:14
EMERGO SUMMARY OF KEY POINTS: US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP). There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits. Brazil’s ANVISA now recognizes nine MDSAP audit organizations.

FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices

Emergo Group Blog - Thu, 08/24/2017 - 22:07
EMERGO SUMMARY OF KEY POINTS: US FDA has provided qualification and submission details for its Early Feasibility Study (EFS) program. The EFS program targets novel and innovative devices for which little or no prior clinical and non-clinical data exist.

Quick Take: What FDA Medical Device User Fee Reauthorization Means for Registrants

Emergo Group Blog - Tue, 08/22/2017 - 16:10
EMERGO SUMMARY OF KEY POINTS: US legislators and President Trump have finally signed off on FDA user fee reauthorizations that will remain in place through 2022. The FDA Reauthorization Act of 2017 (FDARA) keeps current agency funding mechanisms—user fees as well as appropriations from Congress—in place.

FDA Adds UL 2900 for Medical Device Cybersecurity to List of Recognized Standards

Emergo Group Blog - Tue, 08/22/2017 - 00:26
EMERGO SUMMARY OF KEY POINTS: The US FDA has now officially recognized the UL 2900 cybersecurity standard for medical devices. UL 2900-1 covers general cybersecurity requirements for network-connectable devices. FDA medical device applicants may now declare conformity to UL 2900-1 in order to address cybersecurity requirements as part of their US market registration.

Singapore HSA Establishes Priority Review for Qualifying Medical Devices

Emergo Group Blog - Fri, 08/18/2017 - 20:37
EMERGO SUMMARY OF KEY POINTS Singapore’s Health Sciences Authority (HSA) has launched a priority review scheme for qualifying medium- to high-risk medical devices. The new registration route provides faster Singapore market access for devices that address key HSA healthcare areas; are novel; or that target unmet clinical needs. Class A devices as well as some combination products do not qualify for the new registration route.

FDA Pre-Cert Pilot for Medical Software: Key Questions and Eligibility Criteria

Emergo Group Blog - Mon, 08/14/2017 - 20:35
EMERGO SUMMARY OF KEY POINTS: The US FDA will begin its Pre-Certification for Software (Pre-Cert) pilot program for digital health technologies considered medical devices in September 2017. Eligibility requirements for Pre-Cert participation as well as frequently asked questions have been published. As of now, US regulators have not set a deadline for applying to participate in the Pre-Cert program.

CFDA Proposal Would Require Chinese Translations of Foreign Medical Device Applicants' Company Information

Emergo Group Blog - Thu, 08/10/2017 - 17:25
EMERGO SUMMARY OF KEY POINTS: Chinese medical device regulators want to require foreign registrants’ company names and addresses to be provided in Chinese. New Chinese market applicant would be impacted by this requirement starting in January 2018. Existing CFDA registrants would have to comply by the end of 2018.

TÜV SÜD Extends Compliance Deadlines for MEDDEV 2.7/1 Rev. 4

Emergo Group Blog - Wed, 08/09/2017 - 22:39
EMERGO SUMMARY OF KEY POINTS Requirements for demonstrating state of the art under MEDDEV 2.7/1 Rev. 4 are more specific than those in the current Medical Devices Directive (MDD) The MEDDEV is not legally binding TÜV SÜD has decided to extend implementation of MEDDEV 2.7/1 Rev. 4 until the date of application of the Medical Devices Regulation. Until then following Rev. 3 is deemed sufficient.

Compliance Deadlines Approaching for Malaysian Medical Device Registration

Emergo Group Blog - Sun, 08/06/2017 - 17:18
EMERGO SUMMARY OF KEY POINTS: Malaysian regulators at the MDA have set two registration-related deadlines for companies whose market applications are still being processed. Late October 2017 and early January 2018 deadlines will impact Malaysian market registrants whose applications are still under regulatory or Conformity Assessment Body review.

Brazilian Regulators Propose Extending Validity Timeframes for Medical Devices

Emergo Group Blog - Sat, 08/05/2017 - 22:38
EMERGO SUMMARY OF KEY POINTS: ANVISA intends to move medical device registration validity timeframes from five to 10 years. Expanded validity timeframes should result in lower ongoing compliance costs for Brazilian market registrants. The ANVISA proposal will undergo finalization following a 60-day comment period.

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