The Medical Device Authority (MDA), the department of the Ministry of Health in Malaysia, published draft guidance dedicated to notification of refurbished medical devices. The document is intended to assist industry representatives and provide them with the information necessary to maintain compliance with the provisions of the Medical Device Act 2012 and Medical Device Regulations 2012. The authority will accept feedback from all the parties involved in operations with medical devices before February 28, 2020.
In particular, the guidance describes the way the manufacturer must submit notifications regarding refurbished medical devices as it is prescribed by the Act and the appropriate Circular letter No. 1 of 2016.
Refurbished Medical Devices: An Overview
According to the official definition, “Refurbished Medical Devices” are devices that have been wholly or partially rebuilt in order to be used for the original purpose as determined by the manufacturer. This also includes situations when parts of one or several similar used medical devices were utilized to restore the operations of the device. In particular, the refurbishing process could include the following steps:
- Disassembling the device into parts and components;
- Examination of components to identify whether they are suitable to be used;
- Replacing the components that need to be replaced;
- Reassembling the device;
- Performing tests necessary to assess whether the device meets the appropriate criteria (either initial ones or modified respectively), or
- Identifying the device as refurbished.
First of all, the document provides the list of the most important definitions, including but not limited to the following ones:
- An applicant – a person refurbishing medical devices, either the manufacturer or the third party refurbisher,
- Refurbishment – restoring used medical devices by repairing, reconditioning, reworking, updating software, replacing the parts if necessary, where all operations should be conducted in accordance with the appropriate instructions provided by the manufacturer.
Submission of Notification of Refurbished Medical Device
An applicant represented by the manufacturer itself or the third party refurbisher shall submit the appropriate application to the MDA in electronic form using special “Notification of Refurbished Medical Device Form” to the email address specified by the authority. It is allowed to include several medical devices into one application in accordance with the rules on grouping medical devices. The application shall contain all elements required by the authority, namely:
- Name of the legal entity that would be responsible for the refurbished medical device and its full address,
- Type of an applicant (the particular role),
- Establishment license number,
- Name of the particular responsible person, his/her designation and contact details (phone number and email address),
- Names of the device and the brand as indicated in the labeling (the appropriate table should be filled in case if several devices are included in one submission),
- Brief description of the device,
- Intended use of the device as initially defined by the manufacturer,
- Codes in accordance with the Medical Device Nomenclature (e.g. GMDN, HS, UMDNS or other codes),
- Indication of the particular type of the device (general or in-vitro diagnostic), and of the class under the risk-based classification,
- Indication of the number of medical devices available,
- New lot/batch number assigned to the device by the entity performing the refurbishment,
- Information on the grouping of the device in accordance with the Medical Device Regulation 2012.
The application should be supplemented with the appropriate documents and materials, including:
- Catalogs or other printed materials containing the information regarding the initial intended purpose of the device, and also the general description of the device itself and the way it operates,
- The label of the device indicating that it has been refurbished and the refurbishment date,
- Quality Management System (QMS) certificate of the manufacturer (ISO 13485) the scope of which should include the refurbishing activities,
- Declaration of Conformity in accordance with the Medical Device Regulation 2012.
An application should be duly signed by the responsible person with the appropriate power of signature and stamped with the seal of the company. All application submissions are subject to appropriate payment, defined as an administrative charge payable through the bank draft with the indication of the name and contact phone number of the applicant at the back. It is also required to include the text “Notification of refurbished medical device” to identify the transaction. At the same time, the particular amount payable is still to be determined by the authority.
Additional Requirements and Acknowledgement
Upon receipt of the notification duly filed by the applicant, the authority provides an Acknowledgment on Notification Letter confirming that it was properly notified. It is stated that it would be dispatched to the applicant via email in a few days after receiving the application. Such acknowledgement allows its holder to make the refurbished medical device available on the market within the period it is valid.
The authority also imposes certain restrictions related to the acknowledgment, namely:
- The acknowledgement could not be assigned to another person or otherwise transferred,
- The holder of the acknowledgement should be able to provide it upon request,
- The holder of the acknowledgement should prevent any third party from abuse of the acknowledgement,
- The Medical Device Registration Certificate remains valid for 5 years from the date when the initial notification was filed by the applicant except the cases when it was withdrawn before its expiry.
The authority also reserves the right to impose any additional conditions or restrictions that would be reasonably necessary to ensure the safety of the devices and effectiveness of the regulatory framework.
Summarizing the information provided above, the whole process could be divided into the following consecutive steps:
- The applicant (the manufacturer or the third party refurbisher) performs the refurbishment and confirms that the product is a medical device,
- The applicant prepares the notification in the form prescribed by the guidance,
- The applicant submits the notification, supplemented with the documents required by the authority and pays the appropriate fee (administrative charge),
- The Medical Device Authority receives the application,
- The authority performs screening and reviewing of the application,
- The authority issues an acknowledgement letter allowing the applicant to place the device on the domestic market.
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