Services

Service #1

Service #1

Service #1

Consulting

Acting as the Local Authorised Representative (LAR) for medical device registration in Malaysia according to Malaysia Medical Device Act 2012, Medical Device Regulation 2012 (see https://www.mda.gov.my/doc-list/legislation.html) and relevant Guidance Documents (https://www.mda.gov.my/doc-list/guidance-document.html)

Service #2

Service #1

Service #1

Remote consulting

Providing EU MDR (Regulation (EU) 2017/745) related consulting services in particular regarding Technical Documentation / Medical File and Quality Management System Compliance

Helpful Links mdr technische dokumentation

European Commission Medical Device Regulation

European Commission Medical Device Regulation

European Commission Medical Device Regulation

MDR - NEW REGULATION

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en

MEDICAL DEVICES

https://ec.europa.eu/growth/sectors/medical-devices_en

Medical device Coordination Group (MDCG)

European Commission Medical Device Regulation

European Commission Medical Device Regulation

MDCG DOCUMENTS

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

MEDDEV Guidance Documents

European Commission Medical Device Regulation

International Medical Device Regulators Forum (IMDRF)

MEDDEV DOCUMENTS

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

International Medical Device Regulators Forum (IMDRF)

International Medical Device Regulators Forum (IMDRF)

International Medical Device Regulators Forum (IMDRF)

IMDRF DOCUMENTS

http://www.imdrf.org/documents/documents.asp

MDR designated Notified Bodies

International Medical Device Regulators Forum (IMDRF)

Notified Bodies Operations Group (NBOG)

ACCORDING TO REGULATION (EU) 2017/745 ON MEDICAL DEVICES

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

Notified Bodies Operations Group (NBOG)

International Medical Device Regulators Forum (IMDRF)

Notified Bodies Operations Group (NBOG)

NBOG DOCUMENTS

https://www.nbog.eu/nbog-documents/

Harmonised Standards

Harmonised Standards

Harmonised Standards

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

MEDICAL DEVICES

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0001.01.ENG&toc=OJ:L:2020:090I:TOC

ACTIVE IMPLANTABLE MEDICAL DEVICES:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0025.01.ENG&toc=OJ:L:2020:090I:TOC