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

Entry into Force Milestone Reached for European Medical Device, IVD Regulations

Emergo Group Blog - 4 hours 11 min ago
EMERGO SUMMARY OF KEY POINTS: The European Medical Device Regulations (MDR 2017/745) and In Vitro Diagnostic Regulations (IVDR 2017/746) have been entered into force as of May 26, 2017. The Regulations’ entry into force is the last milestone before full implementation of the MDR in May 2020 and the IVDR in May 2022.

China FDA Proposes New Medical Device Clinical Trial Exemptions

Emergo Group Blog - Wed, 05/24/2017 - 22:02
EMERGO SUMMARY OF KEY POINTS: Chinese medical device regulators are proposing new clinical trial exemptions for certain Class II and Class III devices. The draft CFDA exemption lists include 22 Class II and six Class III devices. Manufacturers have until June 20, 2017 to comment on the proposed CFDA exemptions.

FDA Medical Device Cybersecurity Workshop: Potential Solutions but No Silver Bullets

Emergo Group Blog - Wed, 05/24/2017 - 20:21
EMERGO SUMMARY OF KEY POINTS: The recent WannaCry ransomware attack on health systems has illustrated the need for more comprehensive cybersecurity risk management tools for medical devices. One tool under development, ISOSCELES, would provide a platform whereby device’s core functions would be more separate from their more vulnerable networking capabilities. Another tool, CVSS, may prove useful as a scoring system for medical device manufacturers and users to determine which cybersecurity risks are more critical than others.

FDA Medical Device Cybersecurity Workshop: Safety, Security, Usability in Uneasy Balance

Emergo Group Blog - Fri, 05/19/2017 - 15:33
EMERGO SUMMARY OF KEY POINTS: Medical device cybersecurity risk management must involve manufacturers, regulators and end-users to be effective. Understanding how a device fits within a broader healthcare network allows a better understanding of cybersecurity vulnerabilities. Smaller healthcare providers with fewer resources remain largely underserved when it comes to cybersecurity risk management tools for medical devices and technologies.

FDA Medical Device Cybersecurity Workshop: Safety, Security, Usability in Precarious Balance

Emergo Group Blog - Fri, 05/19/2017 - 15:33
EMERGO SUMMARY OF KEY POINTS: Medical device cybersecurity risk management must involve manufacturers, regulators and end-users to be effective. Understanding how a device fits within a broader healthcare network allows a better understanding of cybersecurity vulnerabilities. Smaller healthcare providers with fewer resources remain largely underserved when it comes to cybersecurity risk management tools for medical devices and technologies.

US FDA Seeks Comments on Proposed Conformity Assessment Pilot

Emergo Group Blog - Tue, 05/16/2017 - 22:30
EMERGO SUMMARY OF KEY POINTS: The US FDA has proposed a pilot program for more consistent evaluation of medical device submissions’ adherence to voluntary consensus standards. The Accreditation Scheme for Conformity Assessment (ASCA) Program would utilize accredited testing laboratories to evaluate registrants’ Declarations of Conformity to various consensus standards. The FDA is accepting comment from industry on the ASCA Program through June 30, 2017.

In Brief: Clinical Trial Protocol Writing Tool from US FDA, NIH Now Available

Emergo Group Blog - Mon, 05/15/2017 - 20:11
EMERGO SUMMARY OF KEY POINTS: The US FDA and National Institutes of Health have launched a new writing tool for medical device companies seeking approval to conduct clinical trials. The new clinical trial protocol template was first proposed in early 2016. The template is intended to help applicants seeking Investigational Device Exemption (IDE) approvals.

Australian TGA Seeks Broader Penalty Powers for Medical Device Advertising Violations

Emergo Group Blog - Fri, 05/12/2017 - 19:34
EMERGO SUMMARTY OF KEY POINTS: The Australian Therapeutic Goods Administration (TGA) is seeking additional sanction and penalty powers against medical device and drug companies violating advertising rules. Proposed sanction and penalty tools would allow punishments more commensurate with severity of advertising violations.

Chinese Regulators Set Procedures for Medical Device Expert Panel Meetings

Emergo Group Blog - Thu, 05/11/2017 - 16:22
EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration (CFDA) has formalized procedures for expert panel meetings to discuss medical device registrations. Expert panel meetings are utilized to examine Chinese market authorization applications for innovative or new devices. Expert panel meetings may be requested either by CFDA applicants or by the regulator.

Eurasian Medical Device Regulatory System Advances

Emergo Group Blog - Tue, 05/09/2017 - 16:33
EMERGO SUMMARY OF KEY POINTS: All five members of the Eurasian Economic Union (Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan) are proceeding with full ratification and implementation of unified medical device regulations. EEU members will have to devote more regulatory resources in order to fully implement their cross-border regulatory system. Russian medical device regulators appear intent on keeping their own oversight system in place, at least over the near term.

Common Audit Problems Part 4: Publishing audit reports

Emergo Group Blog - Fri, 05/05/2017 - 17:01
EMERGO SUMMARY OF KEY POINTS: Audit reports to medical device companies should be generated and delivered typically within one week following a quality system audit. Formal audit reports should provide more than just “audit checklists” in order to support management decisions.

European Medical Device, IVD Regulations Now Officially Published

Emergo Group Blog - Thu, 05/04/2017 - 18:37
EMERGO SUMMARY OF KEY POINTS: The European Medical Device Regulations 2017/745 and In Vitro Diagnostic Regulations 2017/746 were published May 5, 2017 in the Official Journal of the European Union (OJEU). Entry into force of the MDR and IVDR will therefore occur on May 26, 2017. The date of application for the MDR will be May 26, 2020.

China FDA Publishes Required Form Templates for Medical Device Recall Process

Emergo Group Blog - Wed, 05/03/2017 - 19:25
EMERGO SUMMARY OF KEY POINTS: Chinese regulators have published required forms for use by manufacturers and registrants in medical device recalls. The forms help clarify China Food and Drug Administration (CFDA) device recall policies and requirements.

Brazil: May 1 Compliance Deadline Stands for New INMETRO Certification Requirements

Emergo Group Blog - Mon, 05/01/2017 - 16:54
EMERGO SUMMARY OF KEY POINTS: May 1, 2017 remains the official deadline for compliance with Brazilian INMETRO Ordinance 54/2016. The new INMETRO ordinance contains stricter certification requirements and higher compliance costs. INMETRO proposals signed by April 30, 2017 will still qualify for certification under previous requirements.

New Sanitary Licensing Regulations for Brazilian Companies in Effect

Emergo Group Blog - Fri, 04/28/2017 - 17:13
EMERGO SUMMARY OF KEY POINTS: New ANVISA regulations incorporate risk factors into decisions about on-site inspections of Brazilian medical device companies seeking sanitary licenses. The new requirements apply only to distributors, Brazil Registration Holders (BRH) and manufacturers based in the country. The new regulations are currently in effect.

UK Medical Device Regulators Introduce “Virtual Manufacturing” to Replace OBL

Emergo Group Blog - Thu, 04/27/2017 - 18:33
EMERGO SUMMARY OF KEY POINTS: The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has redefined Own Brand Labeling (OBL) manufacturers as “virtual manufacturers.” UK regulators will begin requiring virtual manufacturers to hold full technical documentation of devices they sell in Great Britain starting September 1, 2017. Any redacted technical documentation from virtual manufacturers due to proprietary data concerns will have to be justified to UK regulators.

UL Acquires Emergo

Emergo Group Blog - Tue, 04/25/2017 - 21:35
Emergo has been acquired by UL (Underwriters Laboratories) as the consultancy expands its quality assurance and regulatory affairs service offerings.

MDSAP Update: Health Canada Reports Single-Digit Participation Rate So Far

Emergo Group Blog - Fri, 04/21/2017 - 18:39
EMERGO SUMMARY OF KEY POINTS: Health Canada will begin requiring Medical Device License (MDL) holders to participate in the Medical Device Single Audit Program (MDSAP) in early 2019. So far, only 215 of about 3,500 MDL holders required to sign up for MDSAP have done so. Roughly 10% of Health Canada MDL holders are Private Label Medical Manufacturers that do not have to meet ISO 13485 or MDSAP quality system requirements.

Colombian Regulators Speed Up Medical Device, IVD Review Timeframes

Emergo Group Blog - Thu, 04/20/2017 - 19:56
EMERGO SUMMARY OF KEY POINTS: Colombia’s INVIMA is attempting to reduce review timeframes for medical device and IVD registrations. Modification applications for devices and IVDs will be granted automatically by INVIMA, but still go through full review.

Malaysian Regulators Set Deadlines for Combination Product Regulatory Policy

Emergo Group Blog - Tue, 04/18/2017 - 15:44
EMERGO SUMMARY OF KEY POINTS: Malaysian regulators will begin enforcing new combination product registration rules in July 2018. Combination products will have to meet requirements of both the Medical Device Authority (MDA) and the National Pharmaceutical Regulatory Agency (NPRA). Combination products already on the Malaysian market will have to meet new requirements when they renew their registrations.

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