Malaysia Medical Device License Application

Malaysia Medical Device License Application from Malaysia Medical Device License Application

By: Malaysia Medical Device License Application  11-03-2015
Keywords: Consultancy, License Application, Malaysia Authorize Medical Device License

Establishment License Application Base on Malaysia Medical Device Act 2012 (Act 737) that came into effect on 30th June 2013, all Manufacturers, Local Authorised Representative (LAR), Importers and Distributors of medical devices are required to obtain Establishment License and register the medical devices/products with the Malaysia Medical Device Authority (MDA). We provide consultancy support in obtaining Establishment License for Manufacturer, Authorised Representative (AR), Importer and Distributor in compliance with the Malaysia Medical Device Regulation 2012. Our support will also include the development and implementation of ISO13485:2003 and/or GDPMD as specified in the Regulation. Medical Device Registration We provide consultancy support on Medical Devices Registration from device classification, technical file preparation, technical documentation submission and/or device registration with the Authority. Training Service Canadian Medical Devices Conformity Assessment System (CMDCAS) Training EC Directive 93/42/EEC FDA's Medical Device Quality Regulation Training Good Distribution Practices for Medical Devices (GDPMD) Japan Pharmaceutical Affairs Law (JPAL) Medical Devices Regulation Malaysia Medical Devices Regulation Training Australia Therapeutic Goods Administration (TGA) Medical Devices Training ISO 13485:2003 Training ISO 14971 for Medical Device Risk Assessment Training ISO 15189 Medical Laboratories Requirements Audit Service Medical device manufacturers must audit their quality systems on a regular basis to ensure compliance with regulations and international standards. T T Medical provide gap analysis audit, internal audit and pre audit services against ISO13485, Canadian Medical Devices Conformity Assessment System (CMDCAS),EC Directive 93/42/EEC, FDA QSR-21 CFR Part 820, Good Distribution Practices for Medical Devices (GDPMD),Japan Pharmaceutical Affairs Law (JPAL) Medical Devices Regulation, Malaysia Medical Devices Regulation 2012 and Australia Therapeutic Goods Administration (TGA) T T Medical also can conduct on-site supplier audits on your behalf to ensure your supplier comply to the specifications

Keywords: Consultancy, License Application, Malaysia Authorize Medical Device License, Medical Device Manufacturers, Medical License Application,

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11-03-2015

Malaysia Authorize Representative Medical Device

T T Medical provides qualified and professional Authorized Representative Services in Malaysia and will support your regulatory compliance.