On 23 April 2026, the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway1. This initiative is designed to accelerate access to certain…
In March 2026, the Medical Device Authority (MDA) officially launched its Innovative Medical Device Review Pathway, a strategic initiative to support the development and regulatory readiness of innovative medical devices in Malaysia1. Currently, the pathway includes a sole, key initiative:…
In the second quarter of 2026, the European Medicines Agency (EMA) intends to launch a pilot programme to support breakthrough medical devices and in vitro diagnostics (IVDs)1. The aim is to test a pathway that accelerates patient access to highly…
A Notice regarding matters relating to the pre-review of clinical trial protocols for innovative medical devices was issued by the Center for Medical Device Evaluation on 13 March 20261. This initiative allows applicants developing innovative devices to request a pre-review…
Medical Device Coordination Group MDCG 2025-9, Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746, was published in December 20251. A medical device or in vitro diagnostic (IVD) may be described as a breakthrough device (BtX) when it represents…
The National Medical Products Administration has developed and published a Catalogue of High-End Medical Devices Priority for Approval (2025 Edition)1. The Administration will give priority to the review of medical device registration applications for devices listed in the Catalogue (see…
Introduction The Breakthrough Devices Program is intended to expedite the development of, and prioritise the US Food and Drug Administration’s (FDA’s) review of, certain medical devices designated as ‘breakthrough devices’ that provide for more effective treatment or diagnosis of life-threatening…
On 3 July 2025, the National Medical Products Administration (NMPA) published the following 10 measures to optimise the supervision of the total product lifecycle, specifically to support the innovative development of high-end medical devices (e.g. medical robots, high-end medical imaging equipment,…
Feedback has been sought on measures to optimise the supervision of the entire lifecycle and support the innovative development of high-end medical devices1. The term ‘high-end medical devices’ refers to products such as medical robots, high-end medical imaging equipment, artificial…
The Center for Medical Device Evaluation has developed the following two Implementation Rules1: Implementation Rules for the Special Review Application for Innovative Medical Devices by the Medical Device Technology Review Center, covering: Chapter I: General Provisions Chapter II: Innovation…
Announcement No. 3 of 2025, dated 27 March 2025, details further support available for innovative medical device products in China1. For innovative medical device products, after the applicant completes the pre-clinical research and development of the product and the feasibility…
Please tell us a little about yourself and your role at Ropes & Gray. I am a partner in Ropes & Gray’s Singapore office. I focus my practice on life sciences and compliance regulatory matters and have advised many life…
Market overview Japan is the second largest market for medical devices in the world after the USA. This may be because all Japanese citizens are covered by national health insurance and Japanese medical device regulations are harmonised internationally1. Therefore, Japanese…
Anvisa – Brazil’s National Health Surveillance Agency – has invited interested companies to participate in a pilot project designed to support the development of innovative medical devices1,2. During this pilot, Anvisa will analyse the risks posed by the innovative device…
Final guidance on the Breakthrough Devices Program has been updated1,2 to align with the actions outlined in the Center for Devices and Radiological Health’s Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address…
A pilot programme has been launched to test the main elements of a new Innovative Devices Access Pathway (IDAP) and to provide informative learning and feedback to help improve this pathway1. The aim of IDAP is to enable and improve…
Regulatory background The ‘green channel’ is an official expression used by China’s National Medical Products Administration (NMPA) for its three fast-track processes that have been established to encourage innovation and deal with unmet medical needs: innovation approval, priority review, and…
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA) by His Majesty’s Treasury to help bring innovative new medicines and medical technologies to UK patients more quickly1. The funding will be used…
Interested parties had until 20 December 2022 to comment on draft guidance entitled, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care1,2. The draft guidance has proposed updates to clarify how the Breakthrough Devices…
The Center for Devices and Radiological Health (CDRH) has launched a voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot that will begin in fiscal year (FY) 20231. The TAP Pilot is one of the commitments agreed to between…
Pharmaceutical Safety and Environmental Health Bureau Notification 0902-2 of 2 September 2022 sets out details of a pilot programme for the priority review of software as a medical device (SaMD)1. Under the trial, applications for innovative SaMD will receive priority…
To speed up entry to the market for innovative medical devices so that they can be used quickly in clinical settings, the Ministry of Food and Drug Safety (MFDS) has announced plans1 to introduce parallel reviews for the designation of…
Guidance has been drafted1,2 to outline the policy for the Food and Drug Administration’s (FDA’s) participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary programme, facilitated through the Medical Device Innovation Consortium (MDIC), that evaluates the capability…
A second version of MDS-G002, Guidance on Innovative Medical Devices, was published by the Saudi Food and Drug Authority (SFDA) on 14 February 20221. The SFDA has introduced a fast-track approval pathway for innovative medical devices to allow patients faster…
Following a second round of applications, four more medical devices/in vitro diagnostic reagents have received Sakigake Designation in Japan: artificial tracheas; boron neutron capture therapy systems; the UT-Heart; and cancer-related gene panel inspection systems1. The Sakigake Designation is designed to…
Operational specifications have been issued1 for communication between applicants and the Center for Medical Device Evaluation (CMDE) during the technical review of innovative, priority medical device registration applications. Medical devices granted innovative device status are eligible for priority registration approval.…
At the end of November 2019, the Food and Drug Administration (FDA) announced the next steps in its ongoing efforts to advance innovation in medical device sterilisation with ethylene oxide (EtO). The Agency has released the results of its two…
Rules on Supporting Innovative Medical Devices have been drafted and circulated for public comment1. These rules prescribe the procedures and methods for modular review and priority review of medical devices to support the development and commercialisation of innovative medical devices.…
Five new guidance documents have been published recently by the Saudi Food and Drug Authority (SFDA): MDS-G34, Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (11 December 2019)1 The purpose of this guidance is to specify the…
Guidance has been drafted to outline the requirements of an expedited approval process for innovative medical devices1. In an effort to speed up patient access to innovative medical devices whilst still ensuring their safety and effectiveness, the Saudi Food and…
Officials have confirmed that the Ministry of Health, Labour and Welfare is considering establishing a rapid access mechanism for innovative/breakthrough medical devices, whilst still ensuring patient safety, along the lines of the Sakigake system used for certain drugs1. An innovative…
Introduction The Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP) are Food and Drug Administration (FDA) programmes intended to incentivise and speed the development of innovative medical devices that meet certain criteria.The BDPincentivises development of medical devices that…
On 1 December 2018, a revised version1 of the special review procedure for innovative medical devices came into effect, superseding Order 13 from 2014. Three of the most significant changes are as follows: An application for special examination of…
Policies that the Food and Drug Administration (FDA) intends to use to implement the Breakthrough Devices Program, as established by the 21st Century Cures Act, are described in a new final guidance document1,2. The Breakthrough Devices Program is a voluntary…
Introduction The Product Liability Directive 85/374/EEC1 sets out the liability for defective products in the European Union (EU). It is reviewed every five years, with the Commission producing a report that takes into consideration the efficacy of the legislation, its…
An ‘innovation challenge’ has been launched1 by the Food and Drug Administration to provide additional incentives for medical device developers to invest in products that can provide novel solutions to detecting, treating and preventing opioid addiction, addressing diversion of prescription…
Three consultations on regulatory changes that could affect the medical device industry were held in Australia in the final quarter of 2016: Regulatory framework for advertising therapeutic goods1. Comments were solicited on the appropriate body or bodies for the handling…
A Technical Note published in December 2016 has stated that clinical trial data is required for innovative and certain high-risk medical devices in Brazil1. The requirement applies to: all innovative health products, regardless of their risk category (e.g. innovative design,…
Introduction Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act), which has been enforced since November 2014…
A tentative launch date of 1 August 2017 has been set for Singapore’s new Pre-Market Consultation (PMC) Scheme and the new Priority Review Scheme1. The PMC Scheme has been developed to support innovation and device development by ensuring that devices…
Introduction The 21st Century Cures Act was signed into law on 16 December 2016. Putting aside whether enough funds will be dedicated to enacting Food and Drug Administration (FDA) policies, is this the legislation that will bring the FDA back…
Interested parties have until 24 November 2017 to comment on three draft policies that have been issued by the China Food and Drug Administration to encourage and support the innovation of new medical devices and pharmaceuticals: Related Policies about Encouraging…
The South Korean Ministry of Health and Welfare, other governmental organisations, and prominent industry leaders have agreed on measures to support the development and marketing of technological advancements and innovative medical devices1. At a meeting on 26 December 2017, the…
A new guidance document was published in January 20181 to outline the process for obtaining designation for priority review of either Therapeutic Goods Administration (TGA) conformity assessment, or inclusion in the Australian Register of Therapeutic Goods (ARTG). Applications that are…
Comments have been sought on a draft guidance1,2 that describes the policies that the Food and Drug Administration (FDA) intends to use to implement the Breakthrough Devices Program (BDP). The BDP is a voluntary programme for certain medical devices that…
