The article provides a general overview of the regulatory framework for medical devices no longer supported by their manufacturers, emphasizing the key points to be taken into consideration in order to ensure the continued safety of patients.
Table of content
The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published a draft guidance dedicated to the control of obsolete and discontinued medical devices in healthcare or related facilities for public discussion and consultations. Once finalized, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by all the parties involved in operations with such products in order to ensure compliance.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying legislation. The authority has developed this guidance in order to assist industry professionals and healthcare providers in complying with the Medical Device Act 2012 (Act 737) and its accompanying regulations.
The document clarifies regulatory requirements and offers structured recommendations for effective implementation. It is also important to mention that the MDA retains the authority to request additional information or define conditions not explicitly covered in this document for regulatory purposes.
Should contradictions arise between this document and written law, the latter takes precedence.
Introduction
Healthcare technology is evolving rapidly, driven by advancements that introduce new opportunities and challenges. Among these challenges are obsolete, orphaned, or discontinued medical devices, which may still play an essential role in government and private healthcare facilities, wellness centers, or other related institutions.
Such devices must be carefully managed to ensure patient safety and regulatory compliance. Obsolete and discontinued medical devices often encounter difficulties in meeting the registration requirements of Essential Principles of Safety and Performance (EPSP) and Common Submission Dossier Template (CSDT).
The Medical Device Act 2012 [Act 737] Section 5 prohibits the import, export, or market placement of unregistered medical devices. To prevent disruptions in healthcare services, the Medical Device (Exemption) Order 2024 exempts obsolete and discontinued devices from registration and licensing requirements, ensuring seamless healthcare operations.
This guidance outlines a framework to manage these devices, emphasizing patient safety and adherence to operational standards.
Scope and Application
This document applies to all obsolete and discontinued medical devices that align with definitions set out in the Medical Device (Exemption) Order 2024.
It provides:
- Eligibility criteria for devices
- Application procedures
- Responsibilities and obligations of establishments in managing such devices
Terms and Definitions
In order to assist the parties involved with interpreting the relevant provisions of the applicable regulations, the document provides definitions of the key terms and concepts used in the context of the guidance including the following ones:
- Applicant: The responsible individual from the manufacturer or an Authorized Representative (AR).
- Authority: The Medical Device Authority established under the Medical Device Authority Act 2012 (Act 738).
- Discontinued Medical Device: A device no longer distributed but still present in healthcare or related facilities.
- Establishment: As defined in Section 2 of the Medical Device Act 2012 (Act 737), referring to entities responsible for medical device management.
- Government Healthcare Facility: Facilities providing government-maintained healthcare services, excluding privatized or corporatized entities.
- Healthcare Facility: Premises providing healthcare services encompassing a wide array of services, from medical to diagnostic and preventive care. This includes allied health, pharmacy, nursing, and any apparatus or technology used to address health conditions.
- Manufacturer: Defined in Section 2 of the Medical Device Act 2012 (Act 737) as the entity responsible for device production.
- Medical Device: Defined by the same Act, covering any instrument, apparatus, or technology used for medical purposes.
- Obsolete Medical Device: A device rendered outdated due to design changes or technological evolution and no longer in production.
- Private Healthcare Facility: Facilities other than government-operated ones, including private hospitals, clinics, nursing homes, and specialty centers.
- Related Facilities: Healthcare infrastructures under ministry oversight, offering public medical services through hospitals, clinics, and specialized centers.
Key Provisions for Managing Obsolete and Discontinued Medical Devices
The document further outlines the key points of the existing legal framework applicable to the documents covered by the scope of the guidance.
- Eligibility and Exemption: Devices classified as obsolete or discontinued under the Medical Device (Exemption) Order 2024 are exempt from standard registration and licensing requirements to prevent disruptions in healthcare delivery.
- Responsibilities of Establishments: Establishments are responsible for ensuring that these devices remain operationally safe and meet relevant standards despite their exemption status. This includes (a) regular maintenance and monitoring, (b) compliance with safety protocols, and (c) clear documentation of device usage and condition.
- Application Procedures: Authorized Representatives or manufacturers must submit relevant applications under the defined exemption framework. Proper documentation and adherence to procedural requirements are critical.
Conclusion
In summary, the present MDA guidance on managing obsolete and discontinued medical devices describes the key regulatory requirements that are vitally important for ensuring patient safety and regulatory compliance. As explained in the document, the healthcare industry can maintain continuity without compromising standards by exempting these devices from certain registration requirements. The document offers a structured approach, balancing technological evolution with operational needs, thus safeguarding public health.
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