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

FDA Delays Post-market Safety Reporting Requirements for Combination Products

Emergo Group Blog - Wed, 03/21/2018 - 20:32
EMERGO SUMMARY OF KEY POINTS: Postponed FDA enforcement of post-market safety reporting rules (PMSR) for combination products Delay allows combination product applicants more time to implement appropriate reporting and recordkeeping systems and procedures

Health Canada Reclassifies Certain Disinfectants as Medical Devices

Emergo Group Blog - Tue, 03/20/2018 - 19:00
EMERGO SUMMARY OF KEY POINTS: Health Canada will begin regulating some disinfectants and sterilizing solutions including contact lens solution as medical devices. Affected products are now considered Class II devices, but Health Canada intends to eventually reclassify them as Class III devices. Affected manufacturers will have 18 months to obtain Medical Device Licenses (MDL).

Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration

Emergo Group Blog - Fri, 03/16/2018 - 14:18
EMERGO SUMMARY OF KEY POINTS: FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews. Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers. Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.

New Seminar on Human Factors Engineering for Medical Devices in May 2018

Emergo Group Blog - Thu, 03/15/2018 - 18:38
UL’s Human Factors Engineering (HFE) practice will conduct a new seminar on HFE strategies and approaches for medical device manufacturers on May 31, 2018 in Denmark.

Emergo Survey: Tempered Growth Expectations for Medical Device Markets in 2018

Emergo Group Blog - Wed, 03/14/2018 - 14:03
Medical device manufacturers’ growth expectations for markets worldwide have decreased for 2018 compared to previous years due to various regulatory and economic factors, a recent survey shows.

AAMI Webinar on HFE Reports for Medical Device Manufacturers

Emergo Group Blog - Tue, 03/13/2018 - 19:48
A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.

Switzerland to Model Medical Device Regulations on European MDR Requirements

Emergo Group Blog - Fri, 03/09/2018 - 21:11
EMERGO SUMMARY OF KEY POINTS: Swiss medical device market regulators are realigning their requirements to match those of the European MDR and IVDR. Switzerland is revising its Medical Devices Ordinance (MedDO) using a staged approach, with completed revisions planned for 2020.

In Brief: Egypt Extends Registration Requirements for Non-sterile Medical Devices

Emergo Group Blog - Tue, 03/06/2018 - 22:55
Egyptian medical device regulators plan to require registration for moderate- and high-risk non-sterile devices starting April 1, 2018.

FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)

Emergo Group Blog - Tue, 03/06/2018 - 21:22
EMERGO SUMMARY OF KEY POINTS: The FDA GUDID database now has more than 1.6 million records of medical devices registered for sale in the US. Most GUDID data is from Class II devices, and almost half of GUDID records cover implantable devices. So far, orthopedic devices account for 35% of GUDID device records.

New Guidance from China FDA on 3D Printed Medical Device Registration Rules

Emergo Group Blog - Mon, 03/05/2018 - 18:47
EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration has issued draft guidance on regulatory requirements for 3D-printed medical devices. The guidance proposes specific requirements for validation and related testing for additive manufacturing products submitted for CFDA approval. A final version of the CFDA guidance will be published once stakeholder comments have been received and compiled.

Challenges When Designing a Mobile Medical App for Safe and Effective Use

Emergo Group Blog - Tue, 02/27/2018 - 18:13
When designing mobile applications for medical purposes, developers should keep the issue of safe and effective use top of mind.

MDSAP Certification Route Extended to Brazilian, South American Medical Device Companies

Emergo Group Blog - Tue, 02/27/2018 - 17:41
EMERGO SUMMARY OF KEY POINTS: Brazilian regulators now allow domestic manufacturers to apply for quality system certification under the Medical Device Single Audit Program (MDSAP). Previously, ANVISA’s position was to recognize MDSAP certification only for foreign manufacturers.

Indian Regulators Issue FAQ on Medical Device Rules

Emergo Group Blog - Mon, 02/26/2018 - 17:45
EMERGO SUMMARY OF KEY POINTS: A new FAQ from the Indian CDSCO addresses several questions regarding compliance with the new Medical Device Rules 2017. Issues covered in the FAQ include status of medical device registration applications still under review at CDSCO, notified medical device listing changes and standards compliance. India’s Medical Device Rules 2017 went into effect in January 2018.

US FDA Rolling Out Updates to UDI Database in 2018

Emergo Group Blog - Mon, 02/19/2018 - 21:34
EMERGO SUMMARY OF KEY POINTS: US FDA plans updates to its Global Unique Device Identification Database (GUDID) for Spring and Summer 2018. GUDID updates include new file data elements, record accessibility and premarket submission and supplement number requirements.

Eudamed Accessibility for Non-European Authorities

Emergo Group Blog - Mon, 02/19/2018 - 20:35
EMERGO SUMMARY OF KEY POINTS: Some information in Eudamed will be publicly accessible. Typically, non-European authorities only have access to publicly available Eudamed data. The MDR and IVDR keep the option open for non-European countries to exchange data with Eudamed and have access to data that is not publicly accessible, based on reciprocity. The European Commission has indicated IMDRF members of the NCAR system will be the first to get extended access. Eudamed could be a new world standard in data exchange regarding device safety.

Brazilian ANVISA Clarifies Local, Federal Level Medical Device Oversight Responsibilities

Emergo Group Blog - Fri, 02/16/2018 - 20:21
EMERGO SUMMARY OF KEY POINTS: ANVISA has formally mapped out medical device regulatory responsibilities at its federal, state-level and local branches. Under RDC 215/2018, ANVISA oversight responsibilities and structures currently in place are mostly kept as is.

Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies

Emergo Group Blog - Thu, 02/15/2018 - 16:40
EMERGO SUMMARY OF KEY POINTS: Regulatory challenges are affecting larger percentages of both large and small medical device companies heading into 2018, according to a new Emergo survey. In previous years, small and startup companies were more concerned with funding and capital issues than regulatory challenges. Product development, pricing pressure and funding challenges also ranked highly in our 2018 survey.

UDI for Medical Devices Going Global

Emergo Group Blog - Wed, 02/14/2018 - 15:53
EMERGO SUMMARY OF KEY POINTS: Most markets all over the world will have a system for Unique Device Identification within five years. It will likely be possible to have a single code on each device for all these markets. It is likely that those codes will be linked to different databases for each market. In March 2018 the European Commission will publish a guidance document on UDI under the MDR and IVDR.

Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development

Emergo Group Blog - Fri, 02/09/2018 - 15:51
EMERGO SUMMARY OF KEY POINTS: Chinese regulators plan to develop new medical device standards over a two-year period. The standards will cover risk management, quality and clinical trials, and align with international standards, according to CFDA. CFDA will also hire up to 200 additional staff to support standards development.

China FDA Two-track Medical Device Testing Policy May be Coming

Emergo Group Blog - Wed, 02/07/2018 - 18:15
EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration (CFDA) may soon launch a two-track in-country testing pathway for medical devices. A possible commission testing option would cost registrants a fee but allow a potentially faster testing process. No official CFDA rollout of the new testing policy has occurred yet.


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