REHAB RADAR | Global Rehabilitation News Brief: Regulatory Mutual Recognition Becomes Mainstream; Leading Brain-Computer Interface Companies and Chinese Enterprises Expand Overseas in Tandem

The UK and the US have launched a major collaboration on medical device and AI regulation. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have announced the establishment of a deep partnership aimed at creating a “fast track” for innovative products to enter both markets. The collaboration rests on three core pillars:

1. Regulatory Mutual Recognition: Both parties commit to promoting standards harmonization and mutual recognition of regulatory approvals, thereby accelerating the delivery of safe and effective innovative technologies to patients. 2. Co-creating the AI Future: U.S. experts have joined the MHRA’s newly established National Committee on Medical AI Regulation to jointly develop a forward-looking regulatory framework. 3. Establish a trust pathway: The MHRA will establish an internationally trusted approval pathway, under which medical devices approved by the FDA are expected to benefit from a streamlined process and faster access to the UK market. This move will significantly reduce compliance costs for companies and usher in a new era of efficient market entry for medical device manufacturers worldwide.

The Medical Device Authority (MDA) of Malaysia has announced its official accession to the Medical Device Single Audit Program (MDSAP), becoming a new member of this international initiative. MDSAP was jointly launched by regulatory authorities from multiple countries, including the U.S. FDA and Australia’s TGA, with the aim of enabling compliance with the regulatory requirements of several jurisdictions through a single audit. Malaysia’s participation signifies that… Manufacturers may apply for market access in Malaysia by submitting MDSAP certificates and reports. This measure offers key benefits to enterprises, including reducing redundant reviews, accelerating product launches, lowering compliance costs, and enhancing market competitiveness.

As an important market in Southeast Asia, Malaysia’s accession will boost China–Malaysia cooperation in the medical‑device sector. Companies already holding MDSAP certification may directly leverage it, while those planning to apply can include Malaysia among their target markets. Enterprises holding only CE or FDA certification may also assess the feasibility of applying for MDSAP.

Brazil’s National Health Surveillance Agency (ANVISA) has released a new edition of the “Manual for the Registration of Medical Devices and Software as Medical Devices with ANVISA,” designed to align with the updated regulatory framework and provide clear, practical guidance. This update is part of ANVISA’s ongoing revision of its registration manuals for health products and devices, with the primary objectives of ensuring accurate communication and effective implementation of regulatory requirements, enhancing application quality, and reducing the rate of inquiries and rejections. The latest revision incorporates… RDC 751/2022, RDC 657/2022, RDC 848/2024 Three key resolutions cover the software and hardware compliance roadmap.

The manual provides a comprehensive, step-by-step guide, clearly defines product classification, and underscores a spirit of collaboration. Chinese medical device companies that are planning to enter or have already entered the Brazilian market should promptly obtain and carefully study this new manual, and reassess their product compliance strategies.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published the “2026 DORS Fee Guidance.” Shift the UKCA registration fee structure for medical devices from a “one-time application fee” to an “annual registration fee based on GMDN category.” , The new system will take effect on April 1, 2026.

This reform aims to establish a sustainable regulatory funding framework. Key changes include replacing the one-time application fee with an annual charge, calculated based on GMDN Level 2 classification; the MHRA will automatically generate invoices each year on April 1; and the DORS portal will be decommissioned and upgraded as of March 30, 2026. For businesses, cost planning shifts from a lump-sum outlay to an annual budget—companies with large product portfolios may face higher costs, but expenses become more predictable. Companies must complete critical steps—such as cleansing registration data and verifying product classifications—by March 30, 2026, and pay their annual bills within 90 days; late payments will incur severe consequences. Starting in April 2026, updates to company information and related services will no longer be subject to fees.

Risen Medical has expanded its portfolio of therapeutic care products through the acquisition of the Norwegian company Made for Movement. This specialized firm is internationally recognized for its clinically validated neurorehabilitation devices, which provide support to children and adults with neurological conditions. With this move, Risen Medical has strengthened its position in the European market for pediatric and adult rehabilitation care.

U.S. neurotechnology company Paradromics recently announced that its brain–computer interface (BCI) has received approval from the U.S. Food and Drug Administration (FDA) to launch its first long-term clinical trial. According to Nature, early next year, Paradromics—among the biggest competitors to Elon Musk’s neural‑tech firm Neuralink—will implant its BCI in two volunteers who have lost the ability to speak due to neurological disorders or injuries. The trial has two primary objectives: to ensure the device’s safety and to restore patients’ capacity for real-time spoken communication.

U.S. neurotechnology company Synchron has closed a $200 million (approximately RMB 1.4 billion) Series D funding round, led by Double Point Ventures, with participation from ARCH Ventures, Khosla Ventures, Bezos Expeditions, and others. The round did not disclose the financial advisor.

The funding will be used to accelerate the commercialization of its core Stentrode system, including regulatory submissions, manufacturing capacity expansion, and the development of next-generation high‑channel brain–machine interfaces. Founded in 2016, Synchron is among the world’s first medical device companies focused on “transvascular” brain–machine interfaces. Its product enables neural signal acquisition and transmission via a non‑craniotomy approach, offering significant advantages. The company has completed multiple clinical implants in the United States and Australia, with participants able to control computers and smart devices using brain signals.

Following its successful entry into the Thai market, Yuwell Medical has shifted its strategic focus to another major economy in the region—Indonesia—in order to further expand its presence in Southeast Asia and the global market.

At present, the Indonesian market exhibits robust demand for medical devices; however, its capacity for domestic R&D and self-sufficiency in medical equipment remains limited, with roughly 90% of products relying on imports. Meanwhile, Indonesia’s medical device market boasts a substantial annual compound growth rate, reaching as high as 10.8% over the past five years. For Chinese medical device companies, this represents a promising blue‑ocean opportunity worthy of thorough exploration. Against this backdrop, Yuwell Medical, drawing on its successful experience in the Thai market, is systematically expanding into Indonesia through a localization strategy that shifts from product export to co‑building an ecosystem. According to Yuwell’s strategic plan, the company will continue to foster joint research with local healthcare institutions, facilitate cross‑channel resource sharing, and establish a shared after-sales service network, while leveraging its deep roots in the Indonesian market to extend its reach into neighboring regions.

From the deep regulatory coordination between the UK and the US to rule updates in Malaysia and Brazil, global markets are embracing innovative products with unprecedented openness. At the same time, capital and R&D are pouring into disruptive technologies such as brain-computer interfaces, while Chinese companies’ international expansion has evolved from exporting products to co‑building ecosystems.