[APACMed]

MedTech Regulatory Intelligence Watch

Australia
At the end of March, the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019 released by the Department of Health (DoH) took effect. This order, released by the Department of Health (DoH) superseded the Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008. The order represents a conformity assessment standard for quality management systems. It provides an alternative means for medical devices manufacturers to demonstrate that they have applied those parts of the conformity assessment procedures that relate to the implementation and maintenance of a quality management system for device manufacturing.

The DoH also recently published Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2019. This stipulates that, from 1st July 2019, Australian sponsors of therapeutic goods will be required to pay a 2.05% fee increase for FY2020. The increase applies to application fees for registration; listing or inclusion of therapeutic goods (including medicines, biologicals and medical devices) in the Australian Register of Therapeutic Goods (the Register); application fees for licenses to manufacture, or to undertake a step in the manufacture of, therapeutic goods; fees relating to evaluation of therapeutic goods for marketing approval; clinical trial notification fees; application fees for export certificates and inspection fees for manufacturing premises. There is a slight reduction in the application fee for IVDs that are manufactured for export only.

Bangladesh
In accordance with Article 20 of the Bangladesh Environment Protection Act, 1995 (Act No.1 of 1995), the Government of Bangladesh published Waste Generated from Electrical and Electronic Products (E-waste) Management Rules, 2019. These rules will be applied to all manufacturers, traders, shopkeepers, collectors, transporters, repairers, collection center managers, crushers recyclers, auctioneers, exporters, consumers and major users, who are involved in the production, marketing, purchase, sale and distribution of electrical and electronic products.

China
On 2nd May, the National Medical Products Administration (NMPA) released a China Drug Regulatory Science Action Plan. To support the government in its adoption of regulatory science, nine key areas were identified for a first batch of regulatory science research projects, including:

· Technical evaluation and regulatory system of cell and gene therapeutic products;
· Safety evaluation and quality control of nanomedicine;
· Clinical oriented safety evaluation of traditional Chinese medicines;
· Post-market safety monitoring and evaluation of pharmaceuticals;
· Technical evaluation of drug/device combination products;
· Safety and effectiveness evaluation of artificial intelligence medical devices;
· Regulatory science for new materials of medical devices;
· Methodology of utilising the Real-World Data for clinical evaluation of medical devices;
· Safety evaluation methods for cosmetics.

On 22nd April, the NMPA announced the Removal of 36 Mandatory Certificate Requirements in Administrative Procedures for drug and medical device administration with the aim of reducing bureaucratic procedures and improving operational efficiency. This should have a positive impact on a number of procedures relevant to:

· Imported/domestic drug registration and approval;
· Drug license approval;
· Drug import record filing;
· Export approval for assimilated protein and peptide hormone;
· Precursor chemicals approval;
· Dispensing permit for medical institutes;
· Application for duplicate license regarding drug/medical devices manufacturing or marketing;
· Manufacturing of traditional Chinese medicine;
· Application for GSP certificate; 
· Transportation of narcotic and psychotropic drugs.

On 18th April, the NMPA published Technical Review Guideline on Animal Studies for Medical Devices. Part I: Principles of Decision Making. This document will guide the applicants in deciding whether to conduct animal research for a medical device during the research and development stage, and also serves as a reference for regulatory authorities in evaluating the necessity of animal testing during the technical review process. The guidance is applied to in vivo testing, excluding studies on dead and isolated tissues or organs. It includes a list of specific medical devices that may require animal testing. 

On 16th April, the NMPA hosted a workshop on the Medical Device UDI System Pilot Action Plan attended by several stakeholders including the National Health Commission (NHC), the National Healthcare Security Administration (NHSA), hospitals, and manufacturers. Consensus was reached among the participants on the benefits that UDI could bring to facilitate tripartite healthcare system reform in China. APACMed understands that NHSA is planning to utilise UDI as a tool to reform the tendering/procurement and pricing system of high-value medical consumables. Hospitals that have already piloted UDI also supported its implementation for the purpose of traceability, adverse event reporting, and re-evaluation of medical devices. High-risk medical devices (such as implants) and IVDs are likely to be selected as the first batch of products for the UDI pilot program according to the Plan. 

India
On 2nd April, during the 82th meeting of the Drug Technical Advisory Board, an agreement was reached to notify all medical devices as drugs under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 and also to provide exemptions in Rule 90 of the Medical Device Rules, 2017 during the transition period. The Board further agreed that the Central Drugs Standard Control Organization (CDSCO) would require a stronger workforce and infrastructure to regulate all medical devices and recommended the inclusion of dentists and ophthalmologists in the category of experts to be recruited. They concluded that an advisory could be issued to all the States in this regard.

On 2nd April, Ministry of Health and Family Welfare announces in recent Gazette Notification that it has included organ preservative solutions (OPS) to the list of notified medical devices, placing it under the purview of section 3(b)(iv) of the drugs and cosmetics (D&C) act 1940, with immediate effect on 2nd April 2019, after consulting with the Drugs Technical Advisory Board. 

Malaysia
On 1st April, the Notification of Medical Device for Special Access released by the Medical Device Authority (MDA) took effect. Import and entrance of a medical device onto the Malaysian market requires the device to comply with the requirements of the Medical Device Act 2012 (Act 737), including the registration of the device with MDA. However, the Medical Device (Exemption) Order 2016 exempted special access medical devices from registration requirement, provided they fulfill the criteria and submit a notification to the Authority. Subsequent to the receipt of notification from the applicant, an Acknowledgement of Notification will be issued by the Authority.  

Singapore
On 1st April, the Updates to GN-21: Change Notification of Registered Medical Devices released by the Health Sciences Authority (HSA) took effect. HSA has made changes to GN-21 Annex 1 Change Notification (CN) Submission Requirements but no changes to the overall document requirements for CN/CN routes. The document also standardised terms for document requirements across GN-15, GN-17, GN-18, and GN-21 to minimise confusion and further elaboration on examples of the types of documents required for certain document requirements.  

South Korea
On 30th April, Regulation No. 2019-231: Regulations on Management of Safety Information for Medical Devices, Including Adverse Event Reporting published by the Ministry of Food and Drug Safety (MFDS) took effect. Pursuant to Medical Device Act Articles 13(1), 15(6) and 31(1) and its Enforcement Rules Articles 27(1), 33(1)) and 51(4), these MFDS regulations establish how to collect, manage, and use safety information of medical devices and how to report adverse events.

On 30th April, the National Assembly published Act No. 16433: In Vitro Diagnostic Medical Device Act and Act No. 16405: Medical Device Act which will take effect on 1st May 2020. The Acts promote the efficient management of medical devices and IVDs, and further contribute to improvement in national health by addressing matters concerning the manufacturing, import and sale of the above-mentioned products.

On 30th April, Regulation No. 2019-33: Regulations on Clinical Trial Approval (CTA) for Medical Devices published by the MFDS took effect. Pursuant to Medical Device Act Article 10(7) and its Enforcement Rules Article 12(5), these MFDS Regulations stipulate the process for approving protocols of clinical studies for medical devices, its scope, amendments of the protocols, and procedures of protocol applications etc.

On 23rd April, the National Assembly published Act No. 16372: Bioethics and Safety Act which will take effect on 24th October 2019. The Act enhances the health of humans and the quality of human life by creating conditions that allow for the development of life sciences and biotechnologies that can be used to prevent or cure human diseases. Additionally, this act aims to protect human dignity and to prevent harm to human beings by ensuring that these life sciences and biotechnologies are developed safely and in accordance with the principles of bioethics.

Recently, the MFDS released Regulation No. 2019-25: Partial Amendment Notice of 'Good Manufacturing Practice (GMP) and Quality Control for Medical Devices' which will take effect on 1st July 2019. For medical device GMP international harmonization, the international standard for the quality control of the latest medical device (ISO13485: 2016) is reflected into the revised regulation so that a paper review on supplementary GMP documents can replace on-site GMP inspection. 

Recently, the MFDS released a draft on MFDS Circular No. 2019-163: Regulatory Impact Analysis of New Establishment of 'Regulations on Integrated Information Management System for Medical Devices' for public consultation. In accordance with the amendment of Medical Device Act and its enforcement, this draft regulation is intended to specify the details of the subject, scope, registration method and procedure of the information that should be registered in the Medical Device Integrated Information System. 
 
Sri Lanka
National Medicines Regulatory Authority (NMRA) of Sri Lanka issued a draft on Guideline for Classification of Medical Device to the local chambers association. All medical devices which are included in this draft document should be registered with NMRA and licenses are to be obtained for manufacturing, importation, re-packaging, sale, distribution and offers for sale. All foreign medical device manufactures should submit applications for registration through a Marketing Authorization Holder (local agent) in Sri Lanka who will be responsible for the registration, licensing, importation, sale and distribution, handling of quality failures and all aspects pertaining to the particular Medical Device in Sri Lanka. Registration of medical device in Sri Lanka is in accordance with the essential principles of Global Harmonization Task Force (GHTF) and other international standards accepted by NMRA. The purpose of this document is to assist manufacturers in ascribing appropriate risk classes to their medical devices in Sri Lanka, using a set of risk assessment principles described in the document. 

Thailand
On 26 April, the Medical Device Act (Vol.2) B.E. 2562 (A.D 2019) (English version by Tarius machine translation) was released by the Food and Drug Administration of Thailand. This Medical Device Act (Vol.2) will replace the Medical Device Act B.E. 2551 (A.D 2008). 

World Health Organisation (WHO)
WHO released the results for the Technical consultation on the selection of health products, 2019. This consultation mainly surveyed the following four model lists: 1) WHO Model List of Essential Medicines (EML); 2) WHO Model List of Essential In vitro Diagnostics (EDL); 3) WHO Lists of Priority Medical Devices (PMD) and 4) WHO Priority Assistive Products List (APL) on how they are used and might be improved and integrated to meet country needs.

Recently, WHO announced the most wide-ranging Reforms in the Organization’s history. The changes are designed to support countries in achieving the ambitious “triple billion” targets for the next five years: one billion more people benefitting from universal health coverage (UHC); one billion more people better protected from health emergencies; and one billion more people enjoying better health and well-being. Two major changes include: the setup of a new Department of Digital Health to support countries to assess, integrate, regulate and maximize the opportunities of digital technologies and artificial intelligence, as well as a new Division of Data, Analytics and Deliveryto significantly enhance the collection, storage, analysis and usage of data to drive strategic policy changes in countries.
 
APACMed Regulatory Intelligence Editorial Committee 
Dominik Reterski, Masatoshi Sakurai, Rhoel Laderas, Dacia Su, Yasha Huang, Emilie Rapley, Georgia Swan, Chiqi He
APACMed Regulatory Intelligence Working Group 
Adelheid Schneider, Cerline Tsai, Fan Bu, Leslie Kim, Liqin Li, Lisa Chen, Lynn Tseng, Mariana Gebara-Coghlan, Sahjogita Kathuria, Sharad Shukla, Shirley Zhang, Seung-Mi Han, Shivkumar Hurdale, Yohan Bae, Yuho Miyahara, Yuvesh Jain, Victoria Qu 

△ 홈페이지 바로가기