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 Medical Device Regulators Launch FDA-Industry Collaborative Learning Program

Emergo Group Blog - Fri, 03/24/2017 - 17:05
EMERGO SUMMARY OF KEY POINTS: The US FDA has launched an Experiential Learning Program (ELP) for premarket review staff to learn more from industry about medical device manufacturing and quality processes. The FDA’s Center for Devices and Radiological Health (CDRH) is soliciting participation in the ELP from manufacturers, academia, research institutes and insurers. Firms interested in participating in the first phase of the ELP have until April 30, 2017 to submit proposals.

Australian TGA Releases New Clinical Guidelines for Medical Devices

Emergo Group Blog - Thu, 03/23/2017 - 16:21
EMERGO SUMMARY OF KEY POINTS: The Australian TGA has published more detailed guidance on clinical evidence requirements for medical devices and IVD products. TGA clinical evidence requirements are based on GHTF standards and European MEDDEV documents. Australian regulators may demand clinical evidence from medical device and IVD registrants at any time, not just during premarket review.

India Authorized Agent Role Changes under New Medical Device Rules

Emergo Group Blog - Wed, 03/22/2017 - 19:58
EMERGO SUMMARY OF KEY POINTS: India’s new Medical Device Rules include expanded responsibilities for India Authorized Agent in-country representatives. India Authorized Agents will have added importation responsibilities, and CDSCO will allow multiple Agents for imported devices. Agent role changes will go into effect assuming that Indian regulators are able to meet their own early 2018 implementation timeframe.

Common Medical Device QMS Audit Problems: Little or No Audit Preparation

Emergo Group Blog - Tue, 03/21/2017 - 21:26
EMERGO SUMMARY OF KEY POINTS: Despite best intentions, medical device companies’ internal audits are often carried out as last-minute affairs. Formalized audit preparation time, adherence to checklists and simple time management can help a firm’s audit personnel perform their duties more effectively.

Proposed US FDA User Fee Increase would Impact Smaller Medical Device Firms the Most

Emergo Group Blog - Mon, 03/20/2017 - 16:33
EMERGO SUMMARY OF KEY POINTS: The Trump Administration has proposed user fee increases for drug, medical device and other FDA registrants in 2018. Few specifics on the proposed increases make it difficult to determine exactly how medical device firms would be impacted. Smaller manufacturers make up the vast majority of the US medical device industry, and would be most substantially affected by higher FDA fees.

Emergo Survey: Most Medical Device Firms Need Better Understanding of European MDR, IVDR

Emergo Group Blog - Fri, 03/17/2017 - 19:57
EMERGO SUMMARY OF KEY POINTS: Most QA/RA survey respondents report only basic familiarity with new medical device and IVD regulations in Europe. Larger firms with more QA/RA resources claim more thorough understanding of MDR and IVDR requirements. Publishing of MDR and IVDR final versions will likely lead to more companies focusing on what the new regulations will mean for their CE Marking compliance.

Malaysia Update: ASEAN ratification, Medical Device Regulation revisions on the way

Emergo Group Blog - Fri, 03/17/2017 - 14:56
EMERGO SUMMARY OF KEY POINTS Malaysia plans to ratify the ASEAN Medical Device Directive (AMDD) in mid-2017. The Malaysian Medical Device Authority (MDA) plans to publish several new guidance documents in the near future. MDA plans to overhaul Malaysia’s medical device regulatory system are underway.

Emergo Study: FDA 510(k) Submissions from US Companies on the Decline

Emergo Group Blog - Tue, 03/14/2017 - 21:54
EMERGO SUMMARY OF KEY POINTS: US medical device manufacturers are submitting 510(k) applications to the FDA less frequently than in previous years. Due to currency and other issues, 510(k) submissions from foreign companies have increased. Overall, numbers of 510(k) submissions have fallen over the past three years, while review times have increased.

337 Devices May Now be Exempt from US FDA 510(K) Requirements

Emergo Group Blog - Tue, 03/14/2017 - 21:36
EMERGO SUMMARY OF KEY POINTS: The US FDA has proposed exempting hundreds of Class II medical devices from 510(k) requirements. The exemptions are part of the 21st Century Cures Act, passed in late 2016. Newly exempt devices will still need to meet other FDA regulations such as 21 CFR Part 820.

Common QMS Audit Problems: No Management Support

Emergo Group Blog - Fri, 03/10/2017 - 22:40
EMERGO SUMMARY OF KEY POINTS: Getting management buy-in for medical device QMS audits can be a challenge at many firms. Audit personnel at device manufacturers should emphasize audits as essential business practices to gain support from senior executives. Audit reports should highlight specific risk mitigation and cost saving benefits to senior management.

Brazil ANVISA: Half of Some High-risk Medical Device Registration Submissions Rejected in 2016

Emergo Group Blog - Tue, 03/07/2017 - 15:25
EMERGO SUMMARY OF KEY POINTS: Brazilian regulators rejected nearly half of all registration applications for some high-risk medical devices in 2016. ANVISA rejected 14% more “material registro” applications in 2016 than in 2015. Fewer medical device and IVD registration applications were submitted to ANVISA in 2016 than in previous years, due to economic as well as regulatory factors.

South Korean Regulators Clarify Medical Device UDI, KGMP Rules

Emergo Group Blog - Fri, 03/03/2017 - 16:19
EMERGO SUMMARY OF KEY POINTS: South Korea’s MFDS has clarified new and upcoming requirements regarding unique device identification (UDI), KGMP quality system audits and medical device expenditure reports. UDI requirements will come into force on a rolling basis through 2022. Various KGMP audit requirements have been streamlined or eliminated for some device classes.

Mexico: New Allowances for Drug Registration Renewals Likely to Apply to Medical Devices, Too

Emergo Group Blog - Thu, 03/02/2017 - 17:05
EMERGO SUMMARY OF KEY POINTS: Mexican regulators now allow drug registrants to submit product modification and renewal applications simultaneously. It is anticipated that COFEPRIS will eventually extend this allowance to medical device registrants. If extended to medical devices, the COFEPRIS allowance would streamline manufacturers’ obligations in order to obtain registration renewals and approvals for product changes.

MDSAP Update: Lukewarm Interest among Australian Medical Device Companies

Emergo Group Blog - Wed, 03/01/2017 - 16:51
EMERGO SUMMARY OF KEY POINTS: The Medical Device Single Audit Program (MDSAP) ended its pilot phase and became fully implemented in January 2017 in the United States, Canada, Brazil, Australia and Japan. In Australia, only larger medical device manufacturers have shown interest in MDSAP so far. Smaller Australian manufacturers have yet to be sold on MDSAP’s benefits.

India Update: New Medical Device Rules Will Apply Only to Products Currently Regulated by CDSCO

Emergo Group Blog - Mon, 02/27/2017 - 20:46
EMERGO SUMMARY OF KEY POINTS: New Indian Medical Device Rules will cover only those device types that already fall under CDSCO oversight. Existing Indian registrations will remain valid until 2020, according to informal discussions with the CDSCO.

Emergo Survey: Regulatory Issues Remain Biggest Challenge for Most Medical Device Companies

Emergo Group Blog - Mon, 02/27/2017 - 17:54
EMERGO SUMMARY OF KEY POINTS: Regulatory issues continue to be the biggest business challenge for medical device companies of all sizes. Managers at smaller firms report greater concern for funding and capital issues, while largest firms are more challenged by pricing and competition pressures. Medium- and large-sized firms cite product development as a significant challenge, as well.

South African Regulators Set Licensing Deadlines for Medical Device Companies

Emergo Group Blog - Fri, 02/24/2017 - 16:04
EMERGO SUMMARY OF KEY POINTS The South African Medicines Control Council has set an August 2017 deadline for all domestic medical device manufacturers and distributors to register with the regulator. Domestic device wholesalers have until February 2018 to register with the MCC. The registration requirements do not apply to foreign companies, but they must still ensure that their South African importers obtain MCC licenses.

Europe: Final Versions of Medical Device, IVD Regulations Published

Emergo Group Blog - Thu, 02/23/2017 - 16:00
EMERGO SUMMARY OF KEY POINTS Final versions of Europe’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published. The Regulations will enter into power following formal publication in April or May 2017. The text of the Regulations’ final versions appears little changed from their draft versions, but Emergo consultants have begun in-depth analysis of the documents to determine the extent and effects of any changes.

Russian Regulators Extend Deadline for Replacing “Old” Medical Device Licenses

Emergo Group Blog - Wed, 02/22/2017 - 20:11
EMERGO SUMMARY OF KEY POINTS: Russian regulators have extended a deadline to December 31, 2021 whereby medical device registration holders must replace valid certificates issued before 2013. “Old” registration certificate holders may legally sell their devices in Russia until the late 2021 deadline. Russia’s deadline extension aligns with efforts to establish harmonized medical device regulations across five countries under the Eurasian Economic Union agreement.

2017 Industry Outlook: Medical Device Companies Report Robust 2016 Sales

Emergo Group Blog - Mon, 02/20/2017 - 17:30
EMERGO SUMMARY OF KEY POINTS: A third of all medical device companies taking part in Emergo’s 2017 Global Medical Device Industry Outlook survey reported sales increases of 10% or higher for 2016. Smaller firms with fewer employees and lower operating margins were more likely to report sales of 15% or more. Larger firms with higher operating margins and exposure to more markets with challenging conditions were more likely to report lower sales increases.

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