Scope of the Guidance
The document was published by the MDA in order to assist all parties involved in operations with medical devices to maintain compliance with the applicable regulations in general and with the Medical Device Act in particular, which constitutes the core regulatory act governing the relationship in this sphere. At the same time, the authority reserves the right to request any additional materials that would be found reasonably necessary or to set forth any additional conditions the device should meet in order to be allowed to be placed on the market.
In accordance with the aforementioned act, any and all medical devices intended to be marketed in Malaysia should be previously registered, while all the devices already placed in healthcare facilities before the Act entered into force are subject to obligatory registration too. At the same time, for some of these medical devices, the appropriate manufacturer or its authorized representative no longer exists, which makes it impossible to register them under the general procedure. To avoid issues related to such situations, a special Circular Letter on “Control of orphaned, obsolete and discontinued medical devices in hospital or healthcare and related facilities” has been issued by the MDA in order to create a legal basis for using orphaned medical devices in the future. According to the letter, all healthcare facilities using orphaned medical devices should form a list of such devices and submit it to the authority. The present guidance describes in detail the procedure to be used by healthcare facilities to notify properly the Malaysia MDA about the orphaned medical devices used. The document also highlights the particular obligations and the sphere of responsibility of healthcare facilities related to performing operations with such devices. According to the general principle the regulation employs, healthcare facilities using the orphaned medical devices should be responsible for the risk associated with such use and all potential consequences.
The scope of the documents covers all medical devices including the in vitro diagnostic (IVD) ones.
Guidance on Orphaned Medical Devices: Key Points
First of all, the document provides the list of definitions used to describe the most important concepts in terms to provide industry representatives with additional clarification. In particular, the document defines the following terms:
- An applicant. For the purpose of the guidance, an applicant is a healthcare facility irrespectively of whether they are private or state-owned.
- Beyond economical repair (BER) – a specific concept used to describe the situation when costs needed to repair the devices exceed its depreciated value or accumulated maintenance cost plus the estimated cost of repairing the device exceeds its depreciated value.
- Healthcare facility – the main subject of relationship covered by the guidance. Healthcare facilities could be represented by the premises where healthcare services are being provided to the public. For the purpose of the guidance, healthcare services include any medical, dental, pharmacy or other services that should be provided by qualified healthcare professionals, special accommodation intended for the purpose of providing healthcare services, diagnosis and treatment services, preventive services, any services requiring the application of medical devices and equipment for the intended purpose and also any health-related services including ones provided by healthcare para-professionals.
- Orphaned medical device – a device that is already in use in any healthcare facility, providing that neither its manufacturer nor its duly appointed authorized representative are longer available, that creates the situation of absence of the party responsible for medical device registration under the general procedure. As it is stated in the example provided in the guidance, such situations may take place in a case when the manufacturer suspends its operations, winds up or even if the particular manufacturer is unknown.
Besides the aforementioned definition, the document also provides the description of the concept of the responsible person, in the original guidance indicated as “person responsible” that, according to the official definition is a person responsible under all obligations set forth by applicable legislation. According to the document, the responsible person shall meet certain requirements provided by the guidance, namely:
- To be a member of the top management of the company and to have the appropriate powers to make decisions and act on behalf of the company,
- To be domiciled in Malaysia (either as a citizen or a foreigner being an employee of the company and holding the appropriate residence permit).
The guidance describes in detail the obligations of healthcare facilities related to the orphaned medical devices. In particular, they have to identify all medical devices that meet the appropriate definition among the devices they use, confirm that they are medical devices and provide the authority with the list of such devices together with the appropriate declaration of the orphaned medical device.
The document also provides the list of obligations imposed on any person using orphaned medical devices, namely:
- To ensure the device complies with all applicable safety and performance requirements,
- To use the device for the intended purpose initially defined by the manufacturer in a way prescribed in operational documentation supplied with the device,
- To have an appropriate qualification necessary to operate such devices,
- To suspend any operations with a medical device in case if it ceases to comply with safety and performance requirements.
Orphaned Medical Device Notification Form Content
Notifications should be filed to the Malaysia MDA in the electronic form via email. The authority requires the applicants to submit such notifications served in the form of “Notification/Listing of Orphaned Medical Device Form” attached to the guidance. It is allowed to submit one notification covering several medical devices.
According to the information provided in the guidance, the form should contain:
- Name of the applicant (healthcare facility),
- Its address, including the indication of the city, state, postcode, telephone number and email address,
- Details of the contact (responsible) person, including his/her name, designation, division/unit, landline and mobile phone numbers and email address,
- Information about medical device, including its name, brand, model, serial (batch) number, intended purpose as initially defined by the manufacturer, the indication of the date of purchase, current location and indication of the BER criteria,
- Details about the particular person responsible for the orphaned medical device, including his/her name, designation and division or unit.
The document should be signed by the person duly authorized to be a signatory of the application and sealed with the company stamp. In case if it would be found that the application contains any inaccurate or incorrect information, it would be deemed invalid.
The healthcare facility submitting the application would also have to confirm that the device indicated in the application meets the definition of the orphaned medical device for the purpose of the present guidance. The authority additionally emphasizes certain restrictions imposed on operations with such devices. In particular, they could not be sold, loaned, provided for free, donated or otherwise alienated except the exclusions explicitly indicated in the guidance (e.g. selling for disposal), and they also could not be used to perform the research on humans. Actually, such a device could be used for educational purposes, but not for treating or diagnosing the patient.
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