APACMed Newsletter vol.2

[APACMed]

MedTech Regulatory Intelligence Watch

Australia  
On 6th March, Therapeutic Goods Administration (TGA) published four draft guidance documents for public consultation (deadline 29th April) regarding changes to medical device classification.

In Proposed Changes to the Classification of Medical Devices Used in Direct Contact with the Heart, Central Circulatory or Central Nervous Systems, TGA is proposing a classification that differs from European Union Medical Device Regulation (EU MDR), in so far as these medical devices will be considered Class III, regardless of the duration of use or proposed indications. 

The Proposed Medical Device Classification for Human Cells, Tissues and Organs Storage Solutions and IVF Media specifies that classification of non-invasive medical devices that are substances or a mixture of substances intended to be used in vitro, in direct contact with human cells, tissues, organs or with human embryos before implantation/administration, will be classified as Class III (high risk) medical devices. The proposal is in line with EU MDR with additional clarifications. 

The Proposed New Medical Device Classification for Substances Introduced into the Body via a Body Orifice or Applied to the Skin and the Consultation: Proposed Changes to the Classification of Active Implantable Medical Devices (AIMD) and Their Accessories are in line with EU MDR. Classification of AIMD, their accessories, active devices intended for controlling, monitoring or influencing the performance of an AIMD and software that drives or influences the use of an AIMD will be Class III (high risk) medical devices. 

On 6th March, TGA issued a draft on Brexit – Implications for Therapeutic Goods in Australia (deadline 29th April). At the time of writing, the UK and EU have agreed to delay Brexit by 6 months, until 31st October. In the event of a “no deal” exit of the UK from the EU, the TGA will implement transitional arrangements to ensure minimal interruption in the supply of medical devices in Australia. In that case, the TGA will continue accepting conformity assessment documents issued by the UK notified bodies for existing products, while these remain current for the purposes of UK market authorisation. Under the proposed Brexit “deal”, UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be no immediate impact on manufacturers certified by these notified bodies. 

On 1st March, TGA published ISO 13485:2016 Transition Period Ending. TGA is reminding industry about the mandatory compliance to ISO 13485-2016 following the end of the 3-year transition period. All TGA issued ISO 13485:2003 QMS Certificates will expire by 1 March 2019 and cannot be extended beyond the end of the transition period. Since that date, conformity assessment applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard. The TGA can only issue ISO 13485:2016 QMS Certificates to manufacturers who have been audited against the new revision of the standard. 

China 
Recently, Center for Medical Device Evaluation (CMDE) of National Medical Products Administration (NMPA) issued a draft guidance on Evaluation Key Points for Deep Learning in Clinical Decision Support Software for public consultation. This guidance focused on data quality control, algorithm generalization ability, and risks in clinical use throughout the software lifecycle. Industry should continuously advocate for a risk-based and fit-for-purpose regulatory paradigm tailored to the unique needs and challenges associated with software development and deployment. Key areas to influence include a clearly defined scope of “deep learning”, harmonized regulatory framework (with IEC 62304:2006, ISO 14971, and IMDRF N41 guidance) for risk management process, software verification and validation, software modifications, and clinical evaluation. With regards to software modification, US FDA just released a discussion paper on Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).

In anticipation of a potential submission peak for Artificial Intelligence (AI) medical devices resulting from the thriving industry in China, CMDE is currently working on another general review guidance document for AI medical devices, as well as a review guidance document for prioritized (fast track for review) AI medical devices.

India 
In a recent consultation meeting hosted by the Central Drugs Standard Control Organization (CDSCO), the government sought industry perspectives on the five-year roadmap for regulation of all medical devices. CDSCO is planning to develop a database for devices which are not currently regulated; this will require industry to upload the following information: actual manufacturer/legal manufacturer details, ISO 13485 certification copy, and proof of compliance to quality standards, from importer/manufacturer. The CDSCO also intends to hold a press conference to launch the Materiovigilance Programme Of India (MvPI) in order to raise awareness among stakeholders of the adverse events reporting system.  

Japan  
On 23rd March, the Draft Pharmaceutical & Medical Devices Act (PMD Act) revision was submitted to the National Diet, the national bicameral legislature of Japan. The draft proposed several major changes for medical devices: to legalize the “Sakigake” designation (expedited review) system as well as the “Conditional Early Approval System”; to streamline post-market change management process for minor changes on existing products; to introduce a new pre-market review system for medical devices that are continuously improving in the field (e.g. AI mounted devices); to promote e-IFUs and to mandate the barcode (UDI, unique device identification) on labels. Other notable changes include a strengthened compliance framework for manufacturers, and monetary penalties for non-compliant advertising. 

New Zealand 
Recently, the Ministry of Health issued a draft on Therapeutic Products Regulatory Scheme for public consultation (deadline 18th April), which was developed to replace the Medicines Act 1981. The Bill will shift to a principles-based legislative framework. Consequently, the Act will contain less detail, while a large proportion of the requirements will be enshrined in regulations, which will be developed by the Ministry of Health, then require the approval of the Governor General. The regulator will then be able to make rules and notices, but there are restrictions on what these can cover and requirements for when and how they can be made. 

The new scheme will adopt the GHTF/IMDRF global model for device regulation and is expected to commence in late 2022 or early 2023 with a 2-year transition period. Under the new scheme, clinical trials will require a license; product development data will be required as part of product approval; local manufacturers will require a license and overseas manufacturers will be audited and checked via product approval process; pre-market product approval would be required (with some exceptions); register of all approved devices would be required; local wholesalers will require a license (unless exempt); use- and supply-restrictions can be applied; mandatory adverse event reporting (by product sponsors) and full suite of enforcement responses will be implemented.

Philippines  
On 2nd April, the Philippines Food and Drug Administration (FDA) released three draft documents for public consultation (deadline 2nd June) on medical device labeling requirements, clinical investigation and IVD product market authorization, including the Labeling Requirements for Medical Devices; the Guideline of the Conduct of Clinical Investigation of Medical Devices for Human Subjects; and the Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic (IVD) Medical Device Based on the ASEAN Harmonized Technical Requirements.  

South Korea 
On 4th March, Directive No. 134: Regulations on Internal Delegation for Matters Concerning Medical Products released by Ministry of Food and Drug Safety (MFDS) took effect. The Directive delegates the medical product matters, concerning the Pharmaceutical Affairs Act Article 35-2, the Medical Device Act Articles 11 and 15 and the Enforcement Rules of Medical Device Act Articles 9 and 34, to the National Institute of Food and Drug Safety Evaluation (NIFDS). This announcement specifies the role changes of the organization related to medical device approval. Previously this was a one step process to clear all questions for product approval/registration by the technical review team. The responsibilities will now be divided between two teams, the technical review and assessment team for the technical review, and the approval team for administrative review. 

Recently, NIFDS issued a guideline on No. Annaeseo-0759-02: Guide on Good Laboratory Practices (GLPs) to explain how to conduct and manage laboratory (non-clinical) studies for drugs, quasi-drugs, medical device and cosmetic products pursuant to the MFDS Regulation, Good Laboratory Practices (GLPs). According to the regulation, only GLPs accredited biocompatibility test reports carried out by GLP testing labs will be authorised from May 1st, 2019; Non-GLP testing reports are only allowed in certain cases specified by MFDS, such as 1) Non-GLP test report issued between 1st May, 2017 to 30th April, 2019; (2) Non-GLP test report performing as of 15th February 2019; (3) Testing applied before 15th March 2019; (4) In case biocompatibility testing with no GLP accredited testing labs in Korea per single testing; (5) In case MFDS deficiency question letter issued about biocompatibility testing when technical file review applied before 15th March 2019; (6) When the product is proven equivalent to the predicate device of which non-GLP biocompatibility test report submitted in terms of raw material, manufacturing method. The testing method/standard should be equivalent to MFDS regulation on biocompatibility testing. 

Vietnam
Recently, the Department of Medical Equipment and Construction (DMEC) of Ministry of Health (MoH) issued a draft on Guidelines for Evaluation of Registration Dossiers In Vitro Diagnostic Medical Devices (IVD) for public consultation. The purpose of this guidance is to assist the DMEC reviewers in evaluating IVD dossiers. It outlines the requirements for documents and detailed information in the submitted dossier. APACMed is currently working with the local association to provide comments on this guidance, and also plans to organize a workshop for both regulators and industry ahead of the Decree 169 implementation.  

Asian Harmonization Working Party (AHWP) 
AHWP issued a draft guidance on Change Management for Registered Medical Devices for public consultation (deadline end of this month. The document is intended to provide non-binding guidance for regulators and manufacturers to help them manage changes throughout the lifecycle of general medical device, In Vitro Diagnostic (IVD) medical device, and Software as Medical Device.  

International Medical Device Regulators Forum (IMDRF)  
On 19th to 21st March, the IMDRF meeting was organized by the host country Russia in Moscow. The next meeting will be held in Ekaterinburg, Russia, this September. The official outcomes of this meeting will be available on the IMDFR website with updates on working items including 1) Regulated Product Submission led by Canada; 2) Clinical Evaluation led by China; 3) Medical Device Adverse Event Terminology led by Japan; 4) Good Regulatory Review Practice led by US; “Medical Device Premarket Review Organization - Recognition Requirements and Processes” project co-chaired by US and Singapore; 5) Standards led by US; 6) Personalized Medical Devices led by Australia; 7) Unique Device Identification (UDI) led by EU; 8) Cybersecurity co-chaired by US and Canada. In 2020, Singapore will become the rotating Chair and Host country of IMDRF meetings. 

Early this month, the Medical Devices Clinical Evidence Working Group of IMDRF released 3 documents for public consultation (deadline 5th June) to update on GHTF/SG5/N3:2010 (Clinical Investigations), GHTF/SG5/N1R8:2007 (Clinical Evidence) and GHTF/SG5/N2R8:2007 (Clinical Evaluation). This working group is tasked to identify the Essential Requirements of Demonstrating Equivalence between the Device under Application and the Comparable Device for Clinical Evaluation; the Decision-Making Principals for whether a Medical Device Clinical Trial should be Carried Out; the Guidelines for the Acceptance of Overseas Medical Device Clinical Trial Data. And the clinical evaluation of IVD is out of the scope.  

World Health Organisation (WHO) 
WHO issued a draft on Global Strategy on Digital Health for public consultation (deadline 30th April). The Strategy aims to identify areas where WHO, its partners and stakeholders should focus their efforts. It has identified four strategic objectives: 1) Engage Stakeholders on a Shared Global Agenda on Digital Health; 2) Build and Consolidate Global Digital Health Capacity that reflects National Needs; 3) Commit and Engage Stakeholders to advance Digital Health in every Country; 4) Improve Measurement, Monitoring, Research and Practice in Digital Health. 

Recently, WHO issued a draft on Good Chromatography Practices for public consultation. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products. It was developed following a recommendation from the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). This guideline provides information on good practices to be considered in the analysis of samples when chromatographic systems are used. The principles should be applied in the analysis of, for example, raw materials, starting materials, intermediates, in-process materials and finished products. The principles contained in this guideline are applicable to all types of chromatographic analysis used in, for example, assay determination, testing for related substances and impurities, process validation, cleaning validation, cleaning verification and stability testing.

APACMed Regulatory Intelligence Editorial Committee
Dominik Reterski, Masatoshi Sakurai, Rhoel Laderas, Dacia Su, Yasha Huang, Emilie Rapley 
APACMed Regulatory Intelligence Working Group
Adelheid Schneider, Cerline Tsai, Leslie Kim, Liqin Li, Lisa Chen, Mariana Gebara-Coghlan, Sahjogita Kathuria, Sharad Shukla, Shirley Zhang, Shivkumar Hurdale, Yohan Bae, Yuho Miyahara, Yuvesh Jain, Victoria Qu

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