Consultancy Support

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Establishment License Application

Pursuant to the Malaysia Medical Device Act 2012 (Act 737) that came into effect on 30th June 2013, all Manufacturers, Local Authorized Representative (LAR), Importers and Distributors of medical devices are required to obtain Establishment License and register their medical devices/products with the Malaysia Medical Device Authority (MDA).

T T Medical provides consultancy support in obtaining Establishment License for Manufacturer, Authorized Representative (AR), Importer and Distributor in compliance with the Malaysia Medical Device Regulations 2012.

Our support will also include the development and implementation of ISO13485:2003 and/or GDPMD as specified in the Regulations.

Medical Device Registration

The medical devices in Malaysia are regulated by the MDA pursuant to Act 737 and the Medical Device Regulations 2012.

T T Medical provides consultancy support and can act as a Regulatory Consultant to the Local Authorized Representatives in assisting and supporting the registration process of their medical devices to ensure continuous compliance to the respective Act and Regulations governing the medical devices in Malaysia.

Our work scope pertaining to Medical Device Registration device classification, technical file preparation, technical documentation submission and/or device registration with the respective Authority.

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Drugs Registration

The National Pharmaceutical Regulatory Agency (NPRA) regulates all drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the humans’ body pursuant to the Sale of Drugs Act 1952 (Act 368) and Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984).

We provide consultancy support on Drugs Registration to ensure conformity to required standards of quality, safety, and efficacy established by the Drug Control Authority (“DCA”). The outcome of the drug registration process is the issuance or the denial of a pharmaceutical product marketing Authorisation or licence.

Training Service

We provide the following training services:

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

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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 provides 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 Device Regulations, Malaysia Medical Device Regulations 2012 and Australia Therapeutic Goods Administration (TGA)

T T Medical may also conduct on-site supplier audits on behalf of its client to ensure its supplier comply with the required the specifications