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How to comply with Malaysia Medical Device Regulations 2012? Mourad Kholti 5th March 2014 The 17th SE-Asian Healthcare Show, KLCC, Kuala Lumpur

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How to comply with Malaysia Medical Device Regulations 2012? Mourad Kholti 5th March 2014 The 17th SE-Asian Healthcare Show, KLCC, Kuala Lumpur


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Introduction Based in Penang (Malaysia), Andaman Medical Sdn. Bhd. is a consulting firm specializing in Medical Devices Regulatory Affairs and Quality Management. Expertise: Product registrations & licensing in ASEAN region Regulatory Strategies in ASEAN and Europe Quality Management Systems: (ISO 13485, US FDA 21 CFR part 820, GDPMD) Clinical Evaluation Suppliers Auditing Local Authorized Representation Certification audit in partnership with a European Notified Body


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Contents Definitions Local Authorized representative Arrangement of the MDR 2012 Schedules of MDR 2012 Summary Q&A


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Medical Device Authority (MDA) The Medical Device Authority (MDA) is a division in the Ministry of Health Malaysia (MOH) in charge of regulating medical device and its industry players in Malaysia.  Objectives: to protect the public health and safety and, to ensure that new technology is made available for use for patients in a timely manner and at the same time facilitating trades and the medical device industry.   How? through a comprehensive regulatory control and licensing system of: medical device products manufacturers, LAR, importers, and distributors. 


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Overview of the regulatory system


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Contents Definitions Arrangement of the MDR 2012 Schedules Summary Q&A Local Authorized representative


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Definition “Medical device” Act 737, section 2 “medical device” means: any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for an injury investigation, replacement or modification, or support of the anatomy or of a physiological process support or sustaining life control of conception disinfection of medical device, or providing information for medical or diagnostic purpose by means of in-vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and


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Definition “Medical device” b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk declare to be a medical device by order published in the Gazette.


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Definition “Medical device” The compression therapy knee brace is indicated for relief of weak or injured knees. With comfortable, breathable, soft, smell-free, materials, it is recommended for knee joint distortions and effusions, after surgical interventions, scars treatments, oedemas, sprains and contusions. Medical device definition: …diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, Is my product a Medical Device ?


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Definition “Establishment” Act 737, section 2 “establishment” means: a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer and B) an authorized representative* appointed by a manufacturer having a principal place of business outside Malaysia. * person domiciled or resident in Malaysia/a firm or company constituted under the laws of Malaysia


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Appointment of LAr Distributor vs Independent Authorized Representative: Should my distributor focus on sales & marketing or on Regulatory Affairs? Do I have to scrap all my labels, inserts and packaging, if I want to change distributors ? In case of incident due to transportation from the distributor to the end-user, will my distributor defend his company or mine? If my distributor is unable to answer MDA’s questions, does anyone in my company have the skills to do so directly? Will confidentiality be maintained when sharing a CSDT containing technical information with my distributor? Will my distributor stay up to date on regulatory changes in Malaysia and will provide me with timely warning when changes affect my devices?


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Contents Definitions Arrangement of the MDR 2012 Schedules Summary Q&A Local Authorized representative


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Medical Device Regulations 2012 Part I: Preliminary Part II: Conformity Assessment procedure Part III: Registration of Medical Device Part IV: Registration of Conformity Assessment Body Part V: Establishment License Part VI: Export permit Part VII: Labelling Requirements Part VIII: Appeal Part IX: Register


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Part I: Preliminary Regulations come into operation on 1st July 2013 Provides a definition for labelling, licensee, registration holder, conformity assessment.


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Part II: Conformity Assessment procedure All medical devices shall be appropriately classified and grouped All medical devices shall be subjected to conformity assessment Depending on the class, the manufacturer shall appoint a CAB to conduct the assessment If the conformity assessment is successful, CAB will issue: Report Certificate of Conformity


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Part III: Registration of Medical Device Any application for registration of Medical Device shall be made to MDA using the web-based online system The application shall be accompanied with: Application fee Supporting documents Any other information required by MDA Samples of medical device (if required) If MDA is satisfied, the MD will be kept in the register for a period of 5 years Cancellation of registration


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Part IV: Registration of a CAB Any person who wants to become a CAB shall comply with the requirements specified in 4th schedule. The CAB application shall be accompanied with: Application fee Supporting documents Any other information required by MDA If MDA is satisfied, the CAB will be registered for a period of 3 years


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Part V: Establishment license Any application for an establishment license shall be made to MDA using MEDCAST. The application shall be accompanied with: Application fee Supporting documents Certificate and report of conformity assessment Any other information required by MDA If MDA is satisfied, the establishment license will be issued for a period of 3 years Suspension or revocation of establishment license


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Part VII: Labelling requirements Manufacturers shall ensure that the MD is appropriately labelled according to 6th schedule Shall be legible, permanent, and prominent No statement saying that the placement in the market is promoted or endorsed by MDA (fine RM10K and/or 3 months imprisonment)


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Contents Definitions Arrangement of the MDR 2012 Schedules Summary Q&A Local Authorized representative


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Schedules First schedule: Rules of classification Second schedule: Rules of grouping Third schedule: Conformity Assessment procedure Fourth schedule: Requirements for the registration of CAB Fifth schedule: Table of fees Sixth schedule: Requirements for labelling


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1st Schedule: Rules of classification Some important definitions: Invasive medical device Central nervous system Active device intended for diagnosis Hazard Risk etc…


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1st Schedule: Rules of classification 4 classes: The manufacturer shall be responsible for classifying its medical device


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1st Schedule: Rules of classification Classification rules are provided in 2 appendices (tables): Appendix 1 to classify Medical Devices excluding IVD Appendix 2 to classify IVD devices Example: all surgically invasive MD intended for short-term use are in class B (rule 7) If more than one rule is applicable, the higher classification shall apply.


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2nd Schedule: Rules of grouping Medical Devices may be grouped into one of the following categories: single family system set in-vitro kit in-vitro cluster The basic rules of grouping consist of: one generic proprietary name one manufacturer one common intended purpose


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3rd Schedule: Conformity Assessment procedure Collection of evidence of conformity by the Manufacturer. If the manufacturer is not in Malaysia, it shall: authorize a LAr to act on its behalf provide all the evidence of conformity provide necessary support to the LAr for the purpose of the assessment Depending on the class, a CAB shall be appointed to conduct the assessment.


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3rd Schedule: Conformity Assessment procedure Elements of the Conformity assessment: conformity assessment of the QMS conformity assessment of PMS conformity assessment of Technical documentation (CSDT) DoC Once assessment completed


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3rd Schedule: Conformity Assessment procedure (Summary) Source: Medical Device Authority


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3rd Schedule: Conformity Assessment procedure (Appendices) Appendix 1: Essential Principles of Safety and Performance of Medical Device (checklist) Appendix 2: Common Submission Dossier Template Appendix 3: Declaration of Conformity Appendix 4: Requirements on QMS


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4th Schedule: Requirements for the registration of CAB’s This schedule provides the requirements for a person who wish to be registered as a Conformity Assessment Body: requirements on organization requirements on resources and technical competency requirements on independence and impartiality requirements on Quality Management System


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5th Schedule: Table of fees


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6th Schedule: Requirements for labelling Provides requirements for: Location: on the device itself Format: if symbols are used, provide explanation Language: Bahasa Melayu for home-used devices (also for others if required by MDA) Contents: manufacturer AND LAr names, lot nbr, serial nbr, expiry date… IFU: precautions and warnings, etc…


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How do you feel now ?


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Let’s summarize… Preparation Classify your Medical Device Group your devices Identify your CAB Establishment licenses (before June 30th 2014) Manufacturer (ISO13485) Authorized rep (GDPMD) Importer (GDPMD) Distributor (GDPMD) Conformity assessment (before June 30th 2015) Manufacturer QMS Manufacturer PMS Summary Technical Documentation Declaration of Conformity MedCast registration MedCast registration MDA approval


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www.andamanmed.com info@andamanmed.com


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Sources http://www.mdb.gov.my/mdb/


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Q&A


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