ASEAN CSDT Implementation
In Vietnam, a regulatory update marked by Decree 07/2023/ND-CP introduces significant changes to the management of medical devices outlined in Decree 98/2021/ND-CP. This amendment specifically impacts manufacturers and registrants (authorized representatives). The focus of this regulatory update is the implementation of the Common Submission Dossier Template (CSDT) for Class C and D product registration applications, effective from January 1, 2024.
The process of implementing the regulation involves the meticulous preparation of the CSDT, which closely adheres to the guidelines specified in the ASEAN Medical Device Directive (AMDD). This approach mirrors practices in other ASEAN countries. The CSDT encompasses various technical documents essential for the registration of medical devices, such as the Executive Summary, Essential Principles and Evidence of Conformity, Summary of Design Verification and Validation Documents, Pre-clinical test reports, Clinical evidence, and more.
While Decree 07/2023/ND-CP officially takes effect on March 3, 2023, the provisions concerning the CSDT will be enforced starting from January 1, 2024. Stakeholders in the medical device industry in Vietnam are advised to take note of these changes and ensure compliance with the updated regulations to navigate the evolving landscape of medical device management in the country.
SaMD/AI Guidance and Implementation
Thailand has recently introduced a regulatory update impacting manufacturers in the country. The focus of this update revolves around the implementation of guidance concerning Software as a Medical Device (SaMD) and Artificial Intelligence (AI). Manufacturers, specifically, are the entities affected by these regulatory changes. The update aims to provide clear instructions on SaMD and AI, though, as of now, there is acknowledgment of the importation process without a definitive set of instructions.
The regulatory implementation process involved the Thai FDA conducting a public hearing in July 2023. After the hearing, guidelines have been published, encompassing criteria for screening software and AI considered as medical devices. Notably, examples of software not falling under the medical device category have also been outlined, along with a checklist for Active Medical Devices, including SaMD/AI and the required documentation.
Regarding the timeline for implementation, the Thai FDA is actively working to establish a transparent process for SaMD/AI. However, the current guidance lacks coverage for certain processes, such as importation, and there is no specified timeline for the completion of the guidance. Despite this, there is an optimistic anticipation that clarity and completeness of the regulatory framework will improve in the coming year.
Criteria for screening software and AI that are considered medical devices
Examples of softwares that are not considered medical devices
Checklist for Active MD including SaMD/AI required document
Indonesia has recently introduced several regulations on Halal Certification, including UURI No. 33/2014 on Halal Product Assurance, PP No.39/2021 on Guaranteed Halal Product, and the latest one, Presidential Decree No. 6 Year 2023, focusing on Halal Certification for Drugs, Biological Products, and Medical Devices, effective from January 19, 2023.
Under these regulations, products entering, circulating, and being traded in Indonesia must obtain halal certification, except those originating from prohibited materials (Haram). Specifically, medical devices derived from animals are required to be halal certified by the Indonesian government within a specified timeframe. The regulatory authority overseeing this process is the Halal Product Assurance Organizing Body (BPJPH).
The implementation of the halal requirement will be phased in gradually until October 17, 2039, based on risk classes A-D. Non-halal products must be clearly labeled as such. Foreign manufacturers can obtain halal certification either through Indonesia's BPJPH or an overseas certification authority with mutual recognition from BPJPH. Despite the ongoing efforts, the list of recognized foreign halal certification bodies has not yet been released by BPJPH.
The timeline for the enforcement of the regulation varies. Starting from October 17, 2024, food products, beverages, slaughter products, and services must be mandatorily Halal Certified. For drugs, biological products, and medical devices, the enforcement deadline is determined by their risk classification:
- Risk class A: October 17, 2026
- Risk class B: October 17, 2029
- Risk class C: October 17, 2034
- Risk Class D: October 17, 2039
This regulatory update affects clients and manufacturers dealing with products containing animal resources and falls under the purview of the Indonesian government's efforts to standardize and enforce Halal Certification across various sectors.
Quality Management System and Traceability Form
In the latest regulatory update, significant changes have been introduced regarding the implementation requirements on Quality Management Systems (QMS) and the traceability form. This update primarily impacts manufacturers and authorized representatives (AR). The focal point of the regulation revolves around the stringent implementation requirements related to QMS and traceability forms in the context of medical devices. Notably, only QMS standards that are officially recognized will be accepted for both new registrations and re-registrations of medical devices.
From January 1st, 2024, onward, only the QMS standards explicitly listed in the provided table below will be permissible for the processes of new registration and re-registration of medical devices.
Medical Device Advertisement Application
In the second regulatory update, notable changes have been introduced pertaining to the Medical Device Advertisement Application for the year 2023, affecting both manufacturers and authorized representatives (AR). Effective from January 1, 2024, hard copy submissions for advertisement applications will no longer be accepted. Instead, all completed applications must be submitted electronically via email to email@example.com.
Furthermore, the update outlines specific guidelines for the submission procedure. All processing fees associated with the advertisement submissions must be paid through a bank draft or BayarNow, with cash and online payments being strictly prohibited. It is crucial to ensure the accuracy of payment information, as inaccuracies will result in the return of the submission. Once the application is accepted, a receipt will be issued, and it's important to note that the processing fee is non-refundable. This update signifies a shift towards a more streamlined and electronic application process for medical device advertisements, emphasizing adherence to the specified guidelines starting from the beginning of the year 2024.
Updated Application Fees for different types of transactions
In 2020, Administrative Order No. 2020-0017 simplified the licensing process for health-related device establishments. The fees for these establishments are determined by the latest FDA issuance.
In a significant move, PFDA is updating its rates for the first time since 2001. We foresee a significant alteration, as the revised fee structure is expected to undergo a 5x increase compared to the existing rates or will be subject to fluctuations depending on the risk classification.
Regulation for In Vitro Diagnostic (IVD) Registration Certificate (CIVDR)
Since 2014, FDA Circular No. 2014-005 has served as the protocol for registering specific In Vitro Diagnostic (IVD) devices. The registration requirement has been waived for all IVDs not listed in the previous circular, classifying them as non-registrable IVDs.
In a recent update, PFDA has introduced a draft regulation aimed at revising the rules, guidelines, procedures, and prerequisites for IVD registrations to align with ASEAN standards for IVD regulation. According to the draft, IVD products are categorized differently, each with distinct authorization requirements. Additionally, voluntary registration is scheduled to commence in Q2 2023
Good Storage and Distribution Practices for Medical Devices
Effectively managing medical devices involves critical aspects like storage and distribution. Various individuals and entities play key roles in handling medical products, exposing them to potential risks across stages like purchasing, storage, repackaging, relabeling, transportation, and distribution in the supply chain. PFDA has introduced a draft circular outlining the requirements for adhering to good storage and distribution practices for medical devices. This circular serves as comprehensive guidelines for medical device establishments in the Philippines
Adoption of the Post Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)
PFDA will release additional guidelines, supplementing the existing FDA Circular No. 2016-012 that outlines procedures for product recalls. The updates will include specifics on importation/distribution records, complaint records, criteria and format for adverse event reporting, the format for field safety corrective action (FSCA), and other supplementary guidance sourced from Annex 5 of AMDD
Revised 2001 Schedule of fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs
General Regulatory Fees and Charges
CIVDR Draft Regulation
Post Marketing Alert System Draft Regulation
Good Storage and Distribution Practices for Medical Devices
Proposed Guidance on Clinical Evaluation
In Singapore, regulatory updates are underway with the introduction of the proposed GN-20 Guidance on Clinical Evaluation (Rev 3). This guidance addresses several key points, including presenting the Health Sciences Authority's (HSA) stance on the utilization of real-world data in the establishment of clinical evidence for medical devices. Additionally, it provides specific clarifications regarding the clinical evaluation of software medical devices. The guidance aims to align its contents with the International Medical Device Regulators Forum (IMDRF) guidance on clinical evaluation wherever applicable.
It is important to note that these updates have recently undergone a consultation review process, which took place from October 27 to November 30, 2023. However, as of writing, the implementation date for these regulatory changes is yet to be announced. Stakeholders, including manufacturers, registrants, and labs/parties involved in clinical evaluation, should stay informed and be prepared for the forthcoming changes once the implementation date is disclosed.
In 2024, China is set to implement four pivotal regulatory updates in the field of medical devices, reflecting the nation's commitment to advancing healthcare standards. These changes aim to reorganizing categories, streamline approval processes, and align with global best practices, signifying a significant step forward in China's regulatory landscape for medical devices.
Sodium Hyaluronate Products
In a regulatory update issued on November 14, 2022, by the National Medical Products Administration (NMPA) in China, changes were introduced regarding the management category of medical sodium hyaluronate products. The update specifically impacts manufacturers, requiring them to review and potentially alter the management attributes or categories of their products. For those products necessitating a change, the approval number or registration certificate's validity will be limited, with a deadline set at December 31, 2024.
Unique Device Identification (UDI)
In the latest regulatory update issued on February 17, 2023, pertaining to Unique Device Identification (UDI), manufacturers in the medical device industry are mandated to implement the UDI for their products. This directive applies specifically to the third batch of medical device varieties. The deadline for the implementation of UDI for these varieties is set at June 1, 2024.
Starting from June 1, 2024, all manufactured medical devices listed in this batch must possess the Medical Device Unique Identification (UDI) and be submitted to the UDI database. Additionally, medical devices applying for registration on or after June 1, 2024, are required to submit UDI information. For those medical devices that were accepted or granted registration before June 1, 2024, the UDI information must be submitted during the renewal or modification of registration processes.
Improvement of Quality Management Systems
The National Medical Products Administration (NMPA) in China has recently issued a new set of quality management standards for the operation of medical device enterprises. This update, released on December 7, 2023, specifically targets businesses involved in the operation of medical device.
Key points of this update include the addition of a new chapter on "Establishment and Improvement of Quality Management Systems." Furthermore, it clarifies that electronic certificates hold the same legal validity as paper certificates. The update also introduces provisions for novel business formats and emerging operational methods within the medical device industry. The effective date for the implementation of these changes is set for July 1, 2024. Medical device operating enterprises are advised to familiarize themselves with these updated quality management standards to ensure compliance with the new regulations by the stipulated deadline.
Radiofrequency Therapy Products
The last update, released on March 30, 2022, focuses on the field of radiofrequency (RF) beauty devices, specifically those involved in non-ablative RF treatment (09-07-02 category). This update impacts manufacturers of RF treatment devices and RF skin treatment products.
As per the new regulations, manufacturers of RF treatment devices and related products are required to apply for registration in accordance with the specified guidelines. Starting on April 1, 2024, it is emphasized that the production, import, and sale of these devices will be prohibited if the necessary medical device registration certificate has not been lawfully obtained.
Manufacturers operating in the RF beauty industry should take note of these changes and ensure compliance with the new registration requirements by the stipulated deadline of April 1, 2024. This regulatory initiative aims to enhance oversight and safety standards within the RF beauty device sector.
Regulations for Amendment of Listed Medical Devices
In Hong Kong, a recent regulatory update from the Medical Device Division (MDD HK) has implications for various entities, including License Holders/Authorized Representatives (AR), and Local Responsible Persons (LRP), as well as Manufacturers. The regulatory focus revolves around modifications to medical devices listed under the Medical Device Administrative Control System (MDACS), and it aims to ensure the protection of public health by staying informed about these changes.
To provide guidance in managing and reporting modifications, MDD HK issued "Guidance Notes on Changes for Listed Medical Devices" (GN-10) in November 2023. GN-10 specifically assists LRPs in categorizing, managing, and reporting changes to listed medical devices. The intention is to enable LRPs and/or Manufacturers to differentiate changes, categorize them appropriately, and report them to MDD HK accordingly.
The implementation of this regulation involves distinguishing between major and minor changes to medical devices. GN-10 includes flowcharts in Section 4 that serve as assessment tools for determining the nature of changes. Major changes require a Change Application submitted to MDD HK at least 12 weeks prior to implementation, while notification of minor changes should be made within 24 weeks of the LRP becoming aware of the change.
Key points from GN-10 include the requirement that major changes are implemented only upon approval of the respective Change Applications. The altered version of the medical device must be supplied upon approval, while the original version can continue to be supplied concurrently if it complies with the Essential Principles of Safety and Performance, unless otherwise specified by MDD HK. The transition to the changed version should be completed within 24 weeks unless MDD HK specifies otherwise.
The effective date for compliance with GN-10 is January 1, 2024. From this date onwards, Local Responsible Persons and Manufacturers must adhere to the new guidance in managing modifications to listed medical devices under MDACS.