ASIA
Medical device regulation in Asia encompasses a diverse landscape of regulatory bodies and processes. The registration process involves extensive documentation and clinical data submission, with timelines varying based on device complexity. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) regulates devices through a rigorous approval process, requiring clinical trials for certain categories. South Korea's Ministry of Food and Drug Safety (MFDS) manages device approvals, emphasizing safety and efficacy assessments. In India, the Central Drugs Standard Control Organization (CDSCO) governs medical devices, with recent efforts to harmonize regulations with international standards. Throughout Asia, local testing and clinical trials often play a crucial role in the approval process, reflecting the region's commitment to ensuring the safety and effectiveness of medical devices for its populations.
India
In India, medical device manufacturers must engage an importer to register their products with the Central Drugs Standard Control Organization (CDSCO) before they can be sold. The CDSCO approval process involves several steps: first, determining the device classification according to CDSCO's lists; second, appointing an India Authorized Agent to handle registration; third, preparing the device application and supporting documents; fourth, paying the application fee and submitting the application to CDSCO; finally, awaiting CDSCO approval, which results in the issuance of an import license for the device.
Japan
In Japan, manufacturers intending to sell medical or in vitro diagnostic (IVD) devices must first register their products with the Ministry of Health, Labour and Welfare (MHLW), overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) and Registered Certification Bodies (RCBs). The process involves determining the device classification using the Japanese Medical Device Nomenclature (JMDN), appointing a Marketing Authorization Holder (MAH) or a Designated MAH (DMAH), submitting a Foreign Manufacturer Establishment Registration (FMER) application for foreign manufacturers, implementing a Quality Management System (QMS) per MHLW Ordinance No. 169, preparing application forms and required documents, submitting the application to the PMDA or an RCB, undergoing a QMS audit and/or application review, and finally receiving device registration and QMS certificates upon approval, except for low-risk devices which are exempt.
Russia
In Russia, medical device regulations and classification fall under the jurisdiction of the Federal Service for Surveillance in Healthcare (Rosdravnadzor or RZN). Devices are categorized into Classes 1, 2a, 2b, and 3 based on the EU risk-based model. The registration process typically spans 10-16 months, inclusive of time for addressing feedback from RZN and reviewing additional documents. Specific requirements include on-site audits mandated by decree No.135 starting September 2022, though there's a voluntary transition period until December 2023. Local testing within Russia is obligatory, covering biocompatibility, toxicology, EMC testing, and measuring instrument/equipment assessments. Moreover, medical device registration necessitates local clinical trials, with confirmation from technical experts required for Class 2a, 2b, and 3 devices before reopening registration, whereas Class 1 and IVD devices must undergo trials prior to submission to RZN.
South Korea
In South Korea, companies intending to market medical or in vitro diagnostic devices must register their products with the Ministry of Food and Drug Safety (MFDS). The registration process involves determining device classification, appointing a local License Holder, obtaining Korean Good Manufacturing Practices (K-GMP) certification if necessary, preparing an application with supporting documents, and paying relevant fees. Depending on device classification, submission to a review body and potential requests for additional information are required. Upon approval, marketing authorization is granted, and the device registration is published on the MFDS website.
Taiwan
To navigate the process of registering medical devices in Taiwan, companies must adhere to the regulations set by the Taiwan Food and Drug Administration (TFDA). This entails classifying devices based on risk levels (Class I, II, or III), obtaining pre-market approval for all classes, and submitting a comprehensive dossier containing technical details, test reports, and clinical data for Class II and III devices. Additionally, companies need Quality System Documentation (QSD) certification for many devices. For those outside Taiwan, appointing a local agent is necessary for managing registrations.
Singapore
Singapore boasts one of the world's most advanced healthcare systems despite its small size, making it a pivotal hub for medical technology in Asia. Governed by the Health Sciences Authority (HSA), Singapore's medical device regulations adhere to the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. Classification of devices into four tiers determines regulatory pathways, with streamlined routes available for products already authorized in key international markets. Submission dossiers, following the ASEAN CSDT format, necessitate thorough documentation and a Declaration of Conformity to Essential Principles. Foreign manufacturers must engage a Singapore-based Registrant for device registration and representation to the HSA, highlighting the significance of selecting a reliable in-country partner.
Thailand
Thailand’s medical device regulations, overseen by the Medical Device Control Division (MDCD) within the Thai Food and Drug Administration (FDA), are undergoing alignment with the ASEAN Medical Device Directives (AMDD). A recent announcement by the Ministry of Public Health outlines a four-tier classification system for devices based on risk level. Our consultants offer expertise in navigating these regulations. The registration process involves appointing an in-country representative, submitting product information, and paying fees. Medical device classification in Thailand follows the ASEAN risk-based system, with classes ranging from low to high risk, determined by factors such as invasiveness, duration of use, and biological effects for devices, and user expertise and data impact for in vitro diagnostics (IVDs).