The Malaysian Medical Device Authority (MDA) is responsible for enforcing medical device regulations and registering medical devices. In addition to these requirements, manufacturers and importers must obtain a “settlement license” to legally market or sell medical devices in Malaysia. Manufacturers without a local presence in Malaysia must also appoint an authorized representative of Malaysia who is responsible for managing the product registration process and acts as the manufacturer`s legal representative in all stores related to product verification and approval. No, Malaysia does not currently require in-country approval for the registration of medical devices. b) The CAB verifies the proof of conformity (c) The Authority verifies and registers medical devices and authorises installations (d) Requirements for the licensing of facilities Malaysia is a dynamic and growing medical market in Southeast Asia. Let Emergo help you access this growing market. There is a wide range of medical devices ranging from a simple medical device to a very complex and sophisticated medical device. If your device is approved in one of the recognized reference markets (United States, European Union, Australia, Japan, or Canada), you can use that approval and follow a simplified registration process as described below. Download our Malaysia Registration Process Table to better understand this process. Here are the basic steps: Licenses can be transferred from one authorized representative (AR) to another. The new AR completes an application on the Ministry of Health`s MEDCAST online portal. Required documents include the current AR Reporting Form (Appendix B – MDA/GD0041), the termination letter and the new AR authorization letter. The Ministry of Health charges around 500 ringgit (US$115) per registration ID for medical devices.
Are there local labelling regulations? Yes, the MDA registration number and contact details of Malaysia AR must be included. In addition, the marking for amateur devices must be in Bahasa Malay (and may also include English). The Medical Devices Act (MDA) passed in 2012 and the Medical Devices Authority Act (MDAA) represent Malaysia`s first efforts to implement mandatory safety requirements for medical devices marketed or sold in the country. Regulations under the MDA replaced the country`s voluntary product registration system originally introduced in 2006 and now require registration of all medical devices manufactured, imported or distributed in Malaysia. The law also provides for appropriate transition periods for manufacturers to register with the country`s new medical device authority. According to Article 2 of Law 737, “medical device” means any instrument, device, device, machine, device, implant, in vitro reagent or calibrator, software, hardware or other similar or related article: Devices must be subject to a conformity assessment body (CAB) for an abbreviated technical review of the manufacturer`s documentation for Class B devices, C and D. Documents such as ISO certificate, CE certificate, etc. must be submitted to the CAB. After successful verification, the CAB issues the certificate.
A final device registration package, consisting of a Common Submission Package (CSDT), CAB certificate and application, must be submitted electronically [SP1] online to the WMA for review and approval. CAB and device registration certificates are renewed every 5 years. • diagnosis, prevention, monitoring, treatment or mitigation of disease;• diagnosis, monitoring, treatment, mitigation or compensation of injury;• examination, replacement, modification or support of anatomy or physiological process;• support or preservation of life;• design control;• disinfection of medical devices;• provision of information for medical or diagnostic purposes through in vitro examination human body samples; and LOCAL FEES (manufacturers): Registration of foreign manufacturers is not required, but any entity (RA, importer or distributor) dealing with medical devices must apply for the site licence. The term “medical device” includes any device used in health care to diagnose, prevent, monitor or treat diseases or disabilities, but excludes drugs. This definition of medical device includes in vitro diagnostic (IVD) medical devices. Each medical device must comply with section 2 of Law 737 (see MDA/GD/0006) and must be registered under the Act before it can be imported, exported or placed on the market. Click on the questions below for more information on the medical device registration process in Malaysia, regulations and the path to approval. Due to regulatory changes, the registration process may be complicated or extended to a few years. Pacific Bridge Medical`s regulatory advisors can work with you to register your medical devices as efficiently as possible and obtain approval under Malaysia`s new regulatory system. We ensure that your products comply with Malaysian equipment regulations. After receiving the CAB certificate of approval, Class B, C and D medical devices can submit their application for registration via MeDC@St2.0+.
Malaysia is one of the strongest and most powerful markets for foreign medical device manufacturers in Southeast Asia. The Medical Device Authority (MDA), which is part of the Ministry of Health, regulates all medical devices in Malaysia. Before a device is marketed in Malaysia, it must be registered with the Malaysian Medical Device Authority (MDA). What are the MDA review schedules? Inspection schedules in Malaysia vary depending on the classification of the device. Please download our regulatory table, which explains the process for each class and indicates the time, cost and complexity of approval for each class of equipment. The conformity assessment elements shall apply to devices of classes A, B, C and D. Under the Medical Devices (Exemption) Ordinance 2016, Class A medical devices are exempted from conformity assessment procedures by a conformity assessment body under Article 7 of the Act. As a strategic regulatory partner, Freyr provides end-to-end medical device regulatory services covering quality control, classification, clinical safety and market access. We support our clients in all procedural challenges, from regulatory clarification to product registration to dossier preparation and submission. Section 5(1) of the Medical Devices Act 2012 (Act 737) requires that a medical device be registered under the Act before it can be imported, exported or placed on the market.
For this purpose, an application for registration of a medical device must be made in accordance with the requirements of Law 737 and in the manner established by the authority in the Medical Devices Regulations 2012. When a medical device registration application is submitted, the ADM charges an application fee for all classes of medical devices. Please note that the MDA will only begin the assessment process after payment of the application fee has been received. If the application for registration is approved, the MDA charges an additional fee called a registration fee for the issuance of the medical device`s official registration certificate. Please note that Class A products are exempt from the registration fee. In accordance with Article 7 of Law 737, conformity assessment is mandatory for products of classes A, B, C and D. However, following the implementation of the Medical Devices Ordinance 2016 (exemption), Class A medical devices are now exempt from conformity assessment procedures by a CCC. Therefore, Class A medical devices can submit their registration application directly through Medcast.
An application for registration of medical devices may be made according to their grouping. For general medical devices, they can be divided into one of the following categories: a) An organization registered by the authority to carry out certain KT activities to determine whether the relevant requirements of technical regulations or standards are met If the application for registration has been approved, the MDA charges another fee called a registration fee for the issuance of the official registration certificate of the medical device. Please note that Class A products are exempt from the registration fee. To register a medical device for sale in Malaysia, a manufacturer must use the services of a conformity assessment body approved by the Medical Device Authority to review and certify the application for registration. As part of the conformity assessment process, the ACR conducts a review of the technical documentation and an audit of the manufacturer`s quality management system. Certified applications are then submitted to the Medical Devices Authority via an online registration system for final review and approval. Medical devices in Malaysia are classified into 4 risk classes: The conformity assessment policy for medical devices approved by MDA-recognized countries Medical device manufacturers without a local presence in Malaysia require a representative known as an authorized medical device representative, who acts as the liaison between the manufacturer and the Medical Device Authority (MDA) for the registration and submission of the application. MedCast is a centralized, web-based online medical device application system for MDA registration, which can only be done by a local authorized representative.
The representative must hold a site licence and a Good Distribution Practices Medical Device (GDP®) certificate. With an office in Kuala Lumpur, Emergo can assist you with registration and interact with the Medical Devices Authority on your behalf. Here`s how we can help: The conformity assessment (CA) elements for medical device registration include the following: Only companies registered locally in Malaysia with the Companies Commission (SSM) (government body responsible for business registration) can apply for a business license, register a medical device and apply for an export license.