Medical Device Certification

G&M Booth Number 3081 at the Medical Design & Manufacturing (MD&M West) Trade Show in Anaheim, CA – February 9 – 11, 2016

by G&M Compliance (January 21, 2016)

G&M will be exhibiting at the 2016 Medical Design and Manufacturing (MD&M West) in Anaheim, CA from February 9 – 11. Please come visit our booth number 3081. G&M will be introducing our new Certification Management Service (CMS) to medical device manufacturers. Anaheim Convention Center Arena 800 W Katella Ave., Anaheim, CA92802-3496 United States Your […]

Medical Device Certification

FDA adds 4th Edition of IEC 60601-1-2 to List of EMC Consensus Standards for Medical Devices

by G&M Compliance (October 30, 2014)

On July 9, 2014, the FDA added the 4th edition of IEC 60601-1-2, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. […]

Medical Device Certification

New Amendment 1 to EN 60601:2006 has been published by CELELEC

by G&M Compliance (November 5, 2013)

The new CENELEC Amendment 1 to EN60601:2006 (3rd edition) includes all elements from the IEC Amendment 1 from 2012 and additional extra material has been published. Medical Device Manufactures will find increased detail in the new Amendment. The relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices contains […]

Medical Device Certification

Manufacturers of Medical Equipment Have More Time to Comply with IEC 60601-1, 3rd Edition

by G&M Compliance (August 6, 2013)

On August 5, 2013, the U.S. FDA announced the extension of the transition date for IEC 60601-1 3rd edition from June 30, 2013 to December 31, 2013. This means FDA will accept pre-market submissions with test reports assessed to IEC 60601-1 2nd edition through the end of the year. You can read the full notice […]

Medical Device Certification

South Korea MFDS Amends it’s Medical Devices – Requires IEC 60601-1, 3rd Ed + Amendments

by G&M Compliance (August 5, 2013)

There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of May 8th, 2013. 1. Introduction of IEC 60601-1 (third edition) with amendments They will be requiring that for electrical medical devices these products will need to meet IEC 60601-1, 3rd ed. (2005) + Amendments*. […]

Medical Device Certification

Official implementation of Medical Device Regulation (MDR) by Malaysia Medical Device Authority (MDA)

by G&M Compliance (July 2, 2013)

Medical Device Regulations 2012, the subsidiary legislation under the Medical Device Act 2012 (Act 737), has been approved by the Minister of Health and has been published in the Gazette and official enforce on July 1st, 2013. As such, all medical equipment are regulated and subjected to mandatory MDA registration accordingly to subsection 79(2) of […]

Medical Device Certification

CNCA Announced Changes to CCC Product Categories for Medical Devices in China

by G&M Compliance (May 13, 2013)

CNCA announced on May 1st, 2013 that eight (8) types of medical devices no longer fall under mandatory CCC Certification. The food and drug supervision bureau of China and the CNCA both support this change. According to relevant regulations of the “Certification and accreditation regulation of the People’s Republic of China”, “Regulations on the supervision […]

Medical Device Certification

Medical Device Standard Transition Dates – IEC 60601 3rd edition

by G&M Compliance (May 2, 2013)

European Union (EU) General Standard June 1, 2012 European Union (EU) Particular Standards Varies* Canada General Standard June 1, 2012 Canada Particular Standards Varies* United States of America (FDA) July 1, 2013 Brazil Jan. 1, 2014 Japan Published June 1, 2012 *(Transition potentially 2017) Taiwan & Singapore Recognize 3rd Edition, no transition date announced Other […]

Medical Device Certification

ROHS II will be Mandatory on July 22nd, 2014 for Medical, Control and Measurement Equipment

by G&M Compliance (May 2, 2013)

On July 22, 2014, the RoHS II legislative Directive becomes mandatory for medical devices, monitoring and control equipment placed on the market in the European Union. Manufacturers, importers and distributors have specific obligations in order to meet the objective of this Directive. One method for achieving a Presumption of Conformity to the RoHS II Directive […]

Medical Device Certification

IEC 60601-1 Medical Device Standard News

by G&M Compliance (February 7, 2013)

The IEC 60601-1 standard is a globally recognized standard for electro-medical equipment safety, and a parent standard over 60 particular device standards. The third edition (3rd), issued in 2005, has a compliance date of June 2012 for the European market (EN 60601-1:2006), and July 2013 for the US market under FDA and OSHA regulations (ANSI/AAMI […]