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Circular Letter Of The Medical Device Authority |
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Circular Letter Of The Medical Device Authority In view of the problems faced by stakeholders, and an effort to facilitate the industry, Medical Device Authority (MDA) has taken into account the issues raised. After much deliberation the Authority has decided to alleviate and remove all obstacles in the implementation of Medical Device Act (Act 737) as part of our continued role in facilitating the industry. We are pleased to inform that MDA has decided on new policies to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737). The policies are as follows: | NO | TITLE | LANGUAGE | | 1 / 2014 | Establishment As Authorised Representative And Establishment Undertaking Multiple Activities | Malay / English | | 2 / 2014 | Conformity Assessment Procedures For Medical Device Approved By Recognised Countries | Malay / English | | 3 / 2014 | Exemption Of Medical Device From Registration Requirements
Note:The Circular Letter will no longer effective. Please Refer to Medical Device Exemption 2016 | Malay / English | | 4 / 2014 | Medical Device For The Purpose Of Export And Transit And Medical Device For Import/Export From/To Countries Without Diplomatic Ties With Malaysia | Malay / English | | 5 / 2014 | Certification Of Good Manufacturing Practice (GMP) For The Purpose Of Obtaining Establishment License | Malay / English | | 1 / 2016 | Refurbishment of Medical Device | Malay / English | | 2 / 2016 | Medical Device Procurement For Healthcare Institution | Malay | | 3 / 2016 | Change Of Ownership For Medical Device Registration | Malay / English | | 4 / 2016 | Transition Period For Medical Device Labeling | Malay / English | | 5 / 2016 | Imposition Of Charges Or Fees For Product Classification | Malay / English | | 1/2017 | Registration Requirement And Exemption From Labelling For Export Only Medical Device (Withdrawn) | Malay / English | | 2/2017 | National Preparation To Ratify Minamata Convention On Mercury | Malay / English | | 3/2017 | Implementation And Enforcement Of Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combinations Products (Revision 1) | Malay / English | | 4/2017 | Recognition Of Institute For Medical Research (IMR) To Provide The Report Or Data Of Clinical Evidence Or Performance Evaluation For The Purpose Of Conformity Assessment By Conformity Assessment Body | Malay / English | | 1/2018 | Licensing And Medical Device Registration Of Contract Manufacturer For Application Of Free Sale Certificate (Revision 1) | Malay / English | | 2/2018 | Control Of Orphaned, Obsolete And Discontinued Medical Device In Hospital Or Healthcare Facilities Institution | Malay / English | | 3/2018 | Recognition And Listing Of Institute Or Laboratory Which Is Capable To Carrying Out Clinical Evidence Or Performance Evaluation For The Purpose Of Conformity Assessment | Malay / English | | 4/2018 | Exemption From Registration Requirement For Export Only Medical Device | Malay / English |
These circulars shall take effect immediately.
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Last Updated ( Monday, 04 June 2018 )
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