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

Chinese Regulators Launching Medical Device Clinical Trial Inspection Program

Emergo Group Blog - Fri, 07/14/2017 - 16:28
EMERGO SUMMARY OF KEY POINTS: CFDA inspections of medical device clinical trial sites will begin in the near future. CFDA inspectors will be examining traceability and authenticity of clinical data. Clinical trial sponsors and institutions will be notified prior to on-site inspections.

US FDA Finalizes Class II Medical Device Exemptions from 510(k) Premarket Notification Requirements

Emergo Group Blog - Tue, 07/11/2017 - 19:21
EMERGO SUMMARY OF KEY POINTS: List of Class II medical devices exempt from 510(k) requirements now finalized by US FDA More than 1,000 devices are now exempt from 510(k) premarket notification requirements The FDA first proposed these 510(k) exemptions in March 2017.

UL 2900 Cybersecurity Standards Set for FDA Adoption

Emergo Group Blog - Tue, 07/11/2017 - 19:05
EMERGO SUMMARY OF KEY POINTS: A medical device and healthcare networking cybersecurity standard from UL is being recognized by the US Food and Drug Administration. The UL 2900 set of standards will enable US medical device market registrants to assemble evidence to demonstrate proper cybersecurity features for their products. Tools to demonstrate compliance with FDA cybersecurity requirements should help device manufacturers and medical software developers in both pre- and post-market environments.

In Brief: Brazil Adds Irish Standards Authority to List of Accredited MDSAP Auditors

Emergo Group Blog - Fri, 07/07/2017 - 19:33
EMERGO SUMMARY OF KEY POINTS: ANVISA adds National Standards Authority of Ireland (NSAI) to its list of organizations accredited to perform quality management system audits according to MDSAP requirements Several auditing organizations now accredited to perform MDSAP audits in Brazil

India’s CDSCO Issues New List of Medical Devices and their Classifications

Emergo Group Blog - Thu, 07/06/2017 - 17:45
EMERGO SUMMARY OF KEY POINTS: Draft CDSCO list clarifies medical device and IVD types notified for Indian market registration More types of IVD products would fall under Medical Device Rules 2017 notification requirements Formal inclusion of devices requiring registration but not previously added to notification list

Health Canada Crafting Rules for Mandatory Incident Reporting by some Hospitals

Emergo Group Blog - Mon, 07/03/2017 - 20:01
New mandatory medical device incident reporting rules proposed by Health Canada Scope includes all acute-care hospitals in Canada 30-day timeframe for incident reporting proposed

Dutch Regulators Plan US FDA-based UDI Requirements for Medical Devices

Emergo Group Blog - Mon, 07/03/2017 - 17:12
Voluntary agreement between Ministry of Health, industry and hospitals All devices will have a UDI code Only implants with proper UDI codes accepted in The Netherlands starting in July 2018 On June 21, 2017, the Dutch Minister of Health signed an agreement with healthcare providers, manufacturers and distributors of medical devices to introduce an unambiguous identification system for medical devices.

US Senate’s FDA User Fee Reauthorization Bill Advances, without $1 Billion Increase Proposed by Trump

Emergo Group Blog - Fri, 06/23/2017 - 19:15
EMERGO SUMMARY OF KEY POINTS: The US Senate’s proposals for FDA user fee reauthorizations do not include a $1 billion fee increase like that proposed by President Trump. Bills currently under consideration in Congress would add resources to the FDA and overhaul some of the agency’s medical device oversight activities. Lawmakers are aiming to get a final FDA user fee reauthorization bill to President Trump for final approval in summer 2017.

New FDA Guidance Explains Electronic Record Requirements for Medical Device Clinical Trials

Emergo Group Blog - Thu, 06/22/2017 - 21:09
EMERGO SUMMARY OF KEY POINTS New US FDA guidance updates recommendations for using electronic records and signatures in medical device clinical investigations. Clinical trial sponsors are required to ensure reliability, trustworthiness and auditability of electronic records and signatures. Risk-based validation of electronic records and signatures is required especially for critical clinical study data.

FDA Commissioner Proposes more Uniform Approach to Digital Health Products

Emergo Group Blog - Tue, 06/20/2017 - 16:18
EMERGO SUMMARY OF KEY POINTS: The US FDA is planning a new, more systemic program to address whether and how mobile medical apps and digital health products should be regulated. The pilot program may include third-party certification pathways for lower-risk digital products as well as post-market real-world data collection to expedite FDA registrations. The program is expected to launch in the fall of 2017.

In Brief: Brazil’s ANVISA Now accepts both Electronic and Paper Submissions

Emergo Group Blog - Fri, 06/16/2017 - 21:33
EMERGO SUMMARY OF KEY POINTS: ANVISA now accepts both electronic and paper formats for medical device registration submissions. Since June 2016, the regulator had required that regulatory submissions only be in electronic format.

Peruvian Regulators Push for Reduced Medical Device Approval Timeframes

Emergo Group Blog - Wed, 06/14/2017 - 19:50
EMERGO SUMMARY OF KEY POINTS: Peruvian regulators are attempting to speed up medical device review and approval timeframes. DIGEMID has also updated regulations concerning distribution, clinical evaluation and risk management reports.

US FDA to Require IFU, Validation Data for More Reusable Medical Devices

Emergo Group Blog - Wed, 06/14/2017 - 16:56
EMERGO SUMMARY OF KEY POINTS: The FDA has expanded requirements for validation data in 510(K) applications to several types of reusable devices. Validation data requirements go into effect for these devices starting August 8, 2017. Eleven device types comprising 40 product codes have been identified for validation data requirements.

New South African Medical Device Authority Established

Emergo Group Blog - Mon, 06/12/2017 - 16:31
EMERGO SUMMARY OF KEY POINTS: The South African government has formed the South African Health Products Regulatory Authority (SAHPRA) to oversee the country’s medical device and drug markets. SAHPRA is based on elements of South Africa’s Medicines Control Council (MCC). The initial period of implementing the new South African medical device regulatory system ends in August 2017.

Updates to FDA’s eMDR System Planned Through October 2017

Emergo Group Blog - Fri, 06/09/2017 - 17:14
EMERGO SUMMARY OF KEY POINTS: The US FDA is rolling out a new series of updates to its electronic medical device reporting (eMDR) system for adverse events. Updates to the eMDR system have already begun, and will continue through October 2017. Changes to eMDR submissions pertain to UDI, combination products, formatting and problem code data.

US Regulators Change IRB Requirements for Some Medical Device Clinical Trials

Emergo Group Blog - Wed, 06/07/2017 - 16:52
EMERGO SUMMARY OF KEY POINTS: The US FDA no longer requires local Institutional Review Board (IRB) review of medical device clinical studies for Investigational Device Exemptions (IDE) and Humanitarian Device Exemption (HDE) devices. Instead, qualifying clinical trial sponsors may utilize central IRB reviews as part of their US market authorization processes.

FDA Pushes Back UDI Compliance Deadlines for Low-Risk Medical Devices

Emergo Group Blog - Mon, 06/05/2017 - 20:59
EMERGO SUMMARY OF KEY POINTS: US FDA UDI compliance deadlines for Class I low-risk medical devices have been exteneded to September 2020. Direct UDI marking requirements will go into effect in September 2022 for low-risk devices. The extension is necessary for the FDA to address various technology and policy challenges raised as Class II and III medical devices have come into compliance with the new UDI system.

Malaysian MDA Updates Mandatory Problem Reporting Policy for Medical Devices

Emergo Group Blog - Thu, 06/01/2017 - 17:56
EMERGO SUMMARY OF KEY POINTS: The Malaysian Medical Device Authority has updated its mandatory problem reporting criteria. MDA reporting timeframes have been updated to reflect severity of problems involving medical devices for sale in Malaysia.

Australian Regulators Want Faster Market Access for Some Devices Approved Overseas

Emergo Group Blog - Tue, 05/30/2017 - 22:28
EMERGO SUMMARY OF KEY POINTS: The Australian TGA is developing a market access pathway whereby medical devices approved by certain overseas regulators would gain Australian market access without undergoing additional conformity assessments. The TGA has not yet determined which overseas regulatory approvals would be included in the new program. Amendments to existing laws concerning Australian medical device regulation will be introduced throughout 2017 to facilitate implementation of the new pathway.

Trump’s 2018 Budget Again Proposes $1 Billion Increase in FDA User Fees

Emergo Group Blog - Tue, 05/30/2017 - 17:16
EMERGO SUMMARY OF KEY POINTS: The Trump administration is persisting in its proposal to raise FDA user fees for drug and medical device registrants to more than $2 billion for the 2018 fiscal year. The proposal would make user fees the sole source of budgetary resources for the regulator. Congress ultimately determines FDA user fee reauthorizations, however, making the proposed increase highly unlikely.


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