international approval for medical devices


WHO has a mandate as outlined in the World Health Assembly (WHA) Resolution 60 29 "to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices to establish surveillance systems and other measures to ensure the quality safety and efficacy of medical devices and where appropriate to participate in international harmonization"

International Regulation of Medical Device Reprocessing

at Reuse of Single-Use Medical Devices International Journal of Hygiene and Environmental Health Volume 213 Issue 4 (July 2010) Pages 302-307 [hereinafter Journal of Hygiene Report] 2 Council Directive 93/42/EEC (14 June 1993) Article 12a OJ L 169 12 7 1993 p 1 3 Report from the Commission to the European Parliament and the Council: Report on the Issue of the Reprocessing of

Article: Approval of medical devices with radio

Approval of medical devices with radio LinkedIn Twitter Facebook Risk management is essential for the approval of medtech devices By Jakob Steensen The requirement for EMC risk considerations for medical devices is evident in the harmonised standards But how do these risk considerations work in conjunction with the performance requirements for radio equipment and how are tests best

Standards for Medical Devices in Japan

International Classification: Risk base Medical Device Classification: Classification: Risk Level: Type of regulation: Class Ⅰ: Devices with extremely low risk to the human body in case of problems Examples: In vitro diagnostic devices steel made small devices (including a scalpel tweezers) X-ray film devices


International Approval Medical devices are subject to strict performance and safety requirements leading to potentially high development costs A broad market presence can help compensate for this high initial investment One of the greatest challenges for the industry however is the diversity and complexity of regulatory systems in different countries Internationally oriented market

Medical Devices

As a medical device manufacturer there are a number of regulatory requirements you must meet before you can sell your devices on the international market It is essential that your certification body has the capability and expertise to support you with robust product and system certification reviews to ensure patient and user safety Maintaining quality delivering excellence BSI Medical

PMDA Medical Device Registration and Approval in Japan

Medical devices in Japan are classified using a coded predicate system combined with a rule-based risk assessment based on GHTF classification rules Japan Medical Device Nomenclature (JMDN) codes identify the device classification and registration pathway Devices are segmented into General Class I Specified Controlled Class II Controlled Class II Specified Highly Controlled Class III

The New European MDR

The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices In Consulting European Market Regulatory by Stephan Buttron July 11 2016 On May 25 th 2016 the European Commission released the long awaited draft for the proposed European Medical Device Regulation (MDR)

Medical Device Databases

Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room CFR Title 21 CLIA Device Classification FDA Guidance Documents Humanitarian Device Exemption Medsun Reports Premarket Approvals (PMAs) Post-Approval Studies Postmarket Surveillance Studies Radiation-Emitting Products

China Medical Device Registration

The China Food Drug Administration (CFDA) is responsible for medical devices drugs and healthcare services The organization is headquartered in Beijing with offices in each province The Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process The General Administration of Quality Supervision Inspection

CFDA NMPA: Approval of Medical Devices in China

CFDA NMPA: Approval of Medical Devices in China The CFDA the China Food and Drug Administration was replaced on September 1 2018 by the National Medical Products Administration (NMPA) which reports to the Chinese Ministry of Health This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in

Guide to the regulation of medical devices

The regulation of medical devices facilitates the free circulation of these goods in Europe and is intended especially to ensure that: international treaties European directives interpretations of these directives harmonized standards and international consensus documents These documents are referred to on the right European directives: 93/42/EEC 98/79/EC 90/385/EEC European

Approval of Medical Devices

This report describes the approval process for medical devices in the European Union and fifteen countries and also indicates whether or not an expedited approval procedure is available Many of the countries reference EU law including France Germany the Netherlands and Switzerland Israel more readily approves devices with a CE mark (indicating approval in the EU) or an indication that

CFDA NMPA: Approval of Medical Devices in China

CFDA NMPA: Approval of Medical Devices in China The CFDA the China Food and Drug Administration was replaced on September 1 2018 by the National Medical Products Administration (NMPA) which reports to the Chinese Ministry of Health This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in


International Approval Links Contact Our Experts GLP Regulatory Archiving Pharma Pre-Clinical Biological Evaluation Medical devices – Biocompatibility The biological evaluation (or biocompatibility test) of your medical device is a mandatory part of the conformity assessment Biological Evaluation of medical devices by ISO 10993 Evaluations carried out to determine the biological

Approval of Medical Devices

Approval of medical devices in France is closely based on European Union regulations Medical devices must have the CE label indicating conformity with European standards Medical devices are divided into four product classes (I IIa IIb and III) according to their level of risk Medical devices in Class I (with the lowest level of risk) that do not need to be sterile can be auto-certified

Approval Process

52 medical device items are designated as the medical devices subject to tracking and control which need to be traceable as they can cause fatal harm to a human body when an adverse event or a defection occurs while using them - 48 items that are implanted into a human body for over one year - Four (4) life-sustaining items that can be used in places other than medical facilities

Process Validation for Medical Devices

The contents of the seminar are based on international standards and regulations for medical devices including GHTF ISO 13485:2016 and 21 CFR 820 (FDA) In addition key elements of equipment qualification statistical sampling plans change control and the monitoring of validated processes are included using risk-based approaches

Medical Electrical Equipment and Medical Devices

Eurofins Your Trusted Medical Devices Compliance Partner The placing of medical devices (including medical electrical equipment and non-active medical devices) and in vitro diagnostic medical devices on the market is regulated by stringent national and international approval procedures which vary between global regions and countries

Guidance Document: Pre

Medical Device Application Forms Health Canada adapted assembly and technical guide for IMDRF table of contents submissions Declaration of Conformity Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices not including In Vitro Diagnostic Devices

Medical devices regulation basics

Medical devices safety Database of Adverse Event Notifications (DAEN) Consumers Report a problem or side effect Reporting adverse events involving medicines vaccines or medical devices Travelling with medicines and medical devices Leaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices online


ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is the International Standard for quality management systems for the medical devices sector Published in 2016 it is designed to work with other management systems in a way that is efficient and transparent The standard which is now in its third edition received strong support from the FDA

Guideline for Registration of Medical Devices

Guidelines for Registration of Medical Devices (revised April 12 2006) replacement of losses for the registration and market approval and permit license of medical devices shall follow regulations of this set of Guidelines Matters not regulated in these Guidelines shall be handled in accordance with other relevant laws and regulations and regulations announced by the central competent

List of Countries without Formal Regulatory Approval

List of Countries without Formal Regulatory Approval Process Jan 25 2017 Drita Dhami Global regulatory statutes significantly impact healthcare companies Obtaining regulatory approval is one of the biggest hurdles faced by these companies The regulatory landscape is dynamic rules of the road are always changing Moreover regulations not only differ by country but are also product

Two Paths for Medical Device Approval: FDA vs CE

For medical devices the FDA assigns new products a classification of I II or III with Class III devices requiring a far more stringent trial process the Premarket Approval Process or PMA than those in Class I or II The classification is based on the degree of harm the device might pose and the specificity of its indications for use (U S Food and Drug Administration 2014a) However only

Online customer service

Welcome ! If you have any questions or suggestions about our products and services,please feel free to tell us anytime!