Product Services

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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.

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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

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