Pihak Berkuasa Peranti Perubatan Malaysia Kementerian Kesihatan Malaysia Aras 6 Prima 9 Prima Avenue II Block 3547 Persiaran APEC 63000 Cyberjaya Selangor MALAYSIA 603 - 8230 0300 603 - 8230 0200. Malaysias Medical Device Authority MDA has issued guidance on good distribution practices GDP for medical devices.
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When the distribution chain is interrupted by manufacturing steps such as repackaging or relabelling the principles of Good Manufacturing Practice GMP should be applied to these processes.
. Good Distribution Practice for Medical Devices GDPMD is required by the Medical Device Authority of Malaysia or MDA to all medical device manufacturer distributors and service providers. WHO Technical Report Series No961 2011. This guideline is applicable to all organisations and individuals involved in any aspect of the.
Location map Phone. Good Distribution Practice for Medical Devices. Provisions in the guideline.
Malaysian Good Distribution Practice GDP Guidelines. GDPMD specifies the requirements for a quality management system to be established. Our goals of the training are to provide an overview and interpretation of the clauses of GDPMD and to ensure the participants understand the scope and use of GDPMD in meeting the requirements of.
Good Distribution Practice for Medical Devices GDPMD About GDPMD With the effective date 1 July 2013 of Act 737 and Medical Device Regulations 2012 manufacturers and distributors of medical devices are required to apply for their establishment licence to continue carrying out their manufacturing distribution or importing activities. Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors and Importers require Good Distribution Practice for Medical Devices GDPMD certification prior to applying for their Establishment Licence. Good Distribution Practice GDP is the quality assurance component that ensures the consistent storage transportation and handling of goods under suitable conditions as specified by the marketing authorization MA or specification of the product.
Good Distribution Practice GDP is that part of quality assurance which ensures that products are consistently stored transported and handled under suitable condition as required by the marketing authorisation or product specification. The companies involved in the supply chain of medical devices must establish implement and maintain a quality management system. Where an organization choose to outsource any activities that may affect the quality of medical devices the.
TUV SUD Malaysia is authorized to audit for GDPMD and one of the Conformity Assessment Body CAB by MDA. The certification ensures an establishments ability to maintain the quality safety and. GDPMD is a stipulated requirement under the Malaysian Medical Act and its accompanying Regulations affects parties involved in the distribution of medical devices authorized.
Elucidate the requirements for an appropriate management and control of these. Good Distribution Practice for Medical Devices GDPMD Loading. Medicines are stored in the right conditions at.
Medicines in the supply chain are authorised in accordance with European Union EU legislation. Annex 9 Model guidance for the storage and transport of time- and temperaturesensitive pharmaceutical products. There is a transition period of two years and one year respectively for the industry to submit.
The Good Distribution Practice for Medical Devices GDPMD is developed to. Wholesale licence and authorisation holders must comply with good distribution practice to ensure the quality safety and security of medicinal products throughout the pharmaceutical supply chain. Good distribution practice GDP describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
Good distribution practice for medical devices gdpmd GDPMD is a regulatory requirement that affects parties involved in the distribution of medical devices from manufacturers wholesalers importers and exporters as well as distributors regardless of business size. Senior EHS Regulatory Manager 3M Malaysia Sdn Bhd CoCo ee e be a ays a ed ca e ce ssoc a ommittee Member Malaysia Medical Device Association email. Lot 36 Jalan Universiti 46200 Petaling Jaya Selangor.
Guidelines on Good Distribution Practice of The IPEC Good Distribution Practices Guide Europe - Good Distribution Practices Audit Austrian GDP Regulations Czech Republic Guidelines for Correct Distribution of Human Czech GDP Guidelines Adoption and Implementation of the World. The document which addresses certain quality safety and performance provisions in the countrys year-old device regulation applies to authorized representatives of foreign devicemakers importers and distributors. The Good Distribution Practice for Medical Devices GDPMD applies to all companies carrying out activities as stated in the Medical Devices Act 2012 Act 737.
MINISTRY OF HEALTH MALAYSIA GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES GDPMD Appendix 4 Schedule 3 Medical Device Regulation 2012 Seminar Updates on Medical Device Regulations Penang 28 May 2014 Level 5 Menara Prisma No 26 Persiaran Perdana Precinct 3 62675 Putrajaya MALAYSIA 03 8892 2400 03 8892 2500. Biological Pharma Revision H15515. 830am 530pm 1 full day Delivery Mode.
The objective of GDPMD is to ensure the quality safety and. This guideline is applicable to all organisations and individuals involved in any aspect of the. Malaysia Good Distribution Practice for Medical Device GDPMD Date.
Provisions in the guideline. Good distribution practice is a set of standards for the sourcing handling storage and transportation of medicines for human use and their active ingredients. GDPMD specifies the requirements for a quality management system to be established implemented and maintained by an establishment of medical device importerdistributor authorized representative to comply with Malaysian Medical Device Act 2012 Act 737 and Medical Device Regulations 2012.
Cyberjaya 15 December 2021 Medical Device Authority Malaysia MDA has organised two days online training on Good Distribution Practice for Medical Devices GDPMD. When the distribution chain is interrupted by manufacturing steps such as repackaging or relabelling the principles of Good Manufacturing Practice GMP should be applied to these processes.
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