The development of medical devices is significantly influenced by the rapid pace of technology. While these cutting-edge devices may improve healthcare services, they also pose major risks to public health and safety. Due to this, regulatory agencies throughout the world have been continuously developing and updating their regulations to strengthen their management of product registration and mandate that applicants submit more detailed documentation. This article will cover the recently issued, upcoming, and influential worldwide medical device regulation updates for the year 2023 in various countries.
Good Distribution Practice
The Good Distribution Practice of Medical Devices (or CDAKB) was established by the Indonesian Ministry of Health (MoH) to manage the quality control of medical equipment sold in the Indonesian markets. It covers all essential parts of distribution, such as handling products and maintaining records. Moreover, in the event of a product recall, it also offers a channel and access to the distributors and manufacturers. Currently, a certificate of CDAKB compliance is required by MoH for stakeholders and businesses wishing to get or renew their Distribution Licenses (IPAK Certificates) and it is anticipated that these policies will be updated and improved in 2023.
Digital Transformation System
The Indonesia’s Ministry of Health (MoH) has launched the SatuSehat platform last year 2022 for the preparation on their plan to build a Pharmaceuticals and Medical Device Dictionary. This platform will contain unique codes that can be used and integrated into all standardized systems used by medical providers, policymakers, and other stakeholders. This year, 2023 they aim to have a pilot implementation and integration of the system in the pharmaceutical industry.
Regulatory Reliance with HSA Singapore
Regulatory Reliance of Thai FDA with Singapore HSA is an expedited medical device registration program administered by regulatory organizations that offers to shorten the registration process for the manufacturer or importer. The Thai FDA will evaluate the efficacy and safety of the medical device in this program using Singapore as a reference country along with the Health Science Authority (Singapore HSA) agency's evaluation report.
Good Manufacturing Practice (GMP) Update
The Thai Food and Drug Administration’s (TFDA) Good Manufacturing Practices (GMP) certificate is currently a voluntary requirement for local medical device manufacturers. Low-risk medical device manufacturing and notifications do not call for these certificates unless the products are exported, and certain destination nations demand them. The GMP regulations, which would mandate that new manufacturers acquire GMP certificates from the FDA, ISO 13485 certificates from recognized Certified Bodies, or other comparable certificates pre-approved by the FDA, are expected to be emphasized by the Thai FDA this year 2023.
AMDD Harmonization and Full CSTD Submission
Thailand has consistently updated its regulatory framework to comply with the ASEAN Medical Device Directive (AMDD), and most recently, the Thai Food and Drug Administration (TFDA) published a list of medical device categories on their official website for the Full ASEAN Common Submission Dossier Template (CSDT). In 2023, it is projected that the TFDA would publish new policies and improve existing ones to further harmonize with AMDD.
Requirements for Labelling of Medical Devices
The fifth version of the MDA/GD/0026 emphasizes the importance of the necessity for a local manufacturer and AR contact information, such as email, phone number, and website in the labelling, to ensure that the user can get technical support. The "Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition," which goes into effect in January 2023, specifies the labeling requirements that must be met by any businesses wanting to import and distribute medical devices into the Malaysian market.
Change Notification for Registered Medical Device
The fourth version of the Medical Device Authority (MDA/GD/0020) manual was released in 2022 to aid the industry and healthcare professionals in their efforts to adhere to the Medical Device Act (Act 737). It outlines the types of changes pertaining to registered medical devices as well as the conditions that must be followed in order to keep importing, exporting, or marketing the medical devices. The key changes made in this new edition are a) categorization, b) changes in labelling c) change of version for software related devices d) updated turn-around time.
Amendments on Decree No. 98/2021/ND-CP
Decree No. 98/2021/ND-CP governs medical device regulation in Vietnam, although since its adoption on January 1, 2022, the Vietnamese MOH has only granted a small number of new Market Authorization Licenses for Class C and D devices. A draft decree was published as an update to resolve the delays and change several items from their precedent policy. As one of the revisions to the draft, the MOH is anticipated to release the list of medical equipment that must reveal their pricing starting this year 2023. Additionally, the new class C/D medical device registration process will make use of third parties' evaluation.
Certificate of IVD Registration (CIVDR) Regulation
From 2014 till the present, FDA Circular No. 2014-005 has served as the recommended procedure for registering certain IVD devices. The registration process has been waived for all non-listed IVDs on the precedent circular, and they are all regarded as non-registrable IVDs. The PFDA published a regulation draft that aims to revise the rules, guidelines, procedures, and requirements for IVD registrations to comply with the ASEAN requirements on IVD regulation. According to the draft the IVD products are classified into various categories, and each has different authorization requirements. Moreover, they aim to start the voluntary registration on Q2 2023.
Medical Device Unique Device Identification (UDI) System
A guideline document on the medical device unique device identification (UDI) system has been produced by the Health Sciences Authority (HSA). The guidelines state that Singapore would put into place the UDI system designed to ensure the tracking and identification of medical devices approved for use and marketing in the nation. As further explained by the HSA, the first component, which is model-specific, offers details on the actual product, including the precise model, as well as the medical device maker and package configuration.
● Hong Kong
Pilot Run to Prioritize Listed Medical Device in Government Procurement
In Hong Kong, the Medical Device Administrative Control System (MDACS) has been in operation voluntarily since 2004 in anticipation of becoming law. Although it is not currently required for medical devices to be listed with the MDACS, those that are listed, are more likely than their non-listed competitors in the public sector to succeed in the public bidding process. The Department of Health in Hong Kong has initiated a trial program that has started to be in effect since 2022 and includes a new requirement that some medical devices it purchases should preferably be listed under MDACS. Moreover, they may include additional devices under the new requirement.
Implementation Guideline for Bar Code Labeling on Devices
To update the Implementation Guideline for Bar Code Labeling on Containers of Medical Devices, etc., the MHLW has issued PSEHB/PSD Notification No. 0913-2. The regulations are for bar code labeling of consumables, in-vitro diagnostics, and medical devices that are frequently used for medical reasons only at healthcare facilities. The updated guideline presents the usage of barcodes, database registration, data to be displayed according to device type, how to display expiration dates, and exemptions and exclusions.
GMP Clearance Processing Time
All compliance verification application types have temporary extended their GMP Clearance assessment target timeframes by 30 TGA working days (6 calendar weeks). All in-process applications will be subject to this increase immediately. These changes will be reviewed at the end of the financial year (June 2023).
● EU Region
Three Year Transition Period Extension of MDD to MDR
The Medical Devices Regulation (EU) 2017/745 (MDR) transition time will be extended by the European Commission for an additional three years. The proposal is made in response to concerns about the number of devices that have not yet switched over to the MDR, along with the increasing re-certification fee and the extended assessment times. The legislative process to enact the changes is expected to begin in early 2023.
Regulatory Strengthening of Artificial Intelligent (A.I) and Software as Medical Device (SaMD)
Taiwan has recently introduced a number of regulatory revisions relating to artificial intelligence (AI) and machine learning-based software as medical devices. With reference to the rules on the United States, Japan, Korea, and the International Medical Device Regulatory Forum, some of these restrictions were first issued back in 2020 (IMDRF). These rules are anticipated to be improved upon and changed in 2023 in order to guarantee the functionality, effectiveness, and caliber of medical device software, particularly those which make use of artificial intelligence (AI).
New Mandated Standards According to Device Category
China NMPA released an updated medical device compulsory standard covering a wide variety of medical devices. Some of these new criteria have already gone into effect in 2022, while others will start on May 1st, 2023, and continue through May 2024 and 2025. Manufacturers must ensure that they have updated paperwork demonstrating that their products adhere to the new specifications. Additionally, the NMPA may change these criteria once more in 2023 as part of their ongoing standard-setting process.
● Indonesia: The Future of Health in Indonesia, GDP Update (No.43)
● Thailand: Regulatory Reliance with HSA Singapore, Good Manufacturing Practice Update,
● Vietnam: Amendments on Decree No. 98/2021/ND-CP
● Malaysia: Labelling Guidance (MDA/GD/0026), Change Notification of Registered Medical Device
● Philippines: IVD Regulation Draft, PFDA Updates on IVD Regulation
● Singapore: Guidance on Medical Device Unique Device Identification (UDI) System
● Hong Kong: Pilot Run to Prioritize Listed Medical Device
● Japan: Implementation Guideline for Bar Code Labeling on Devices
● Australia: GMP Clearance Update
● EU Region: Transitional Provisions, Proposal for Extension
● Taiwan: Guidance for Classification of SaMD, Product Registration of A.I/Machine Learning-based SaMD
● China: List of Mandatory Standards Applicable to Medical Device Products