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The Health Sciences Authority (HSA) has published a guidance document dedicated to medical device recalls. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. Furthermore, medical device manufacturers and other parties involved are encouraged to obtain additional legal advice with respect to the matters since the recommendations provided in the guidance are non-exhaustive. 

The document describes in detail the approach to be followed by the parties involved when conducting a recall related to medical devices placed on the country’s market.

Regulatory Background 

Under the general rule, all the entities conducting operations with medical devices are obliged to develop and implement documented procedures to:

• Conduct effective and timely recalls;
• Ensure that defective or potentially defective medical devices are removed from the market or that measures are taken to correct the defect in an effective and timely manner;
• Ensure that any medical devices to be recalled are notified to the authority on or before initiation of any action;
• Ensure that the authority is made aware of their results and of the action taken to prevent the recurrence of the problem.

Recommendations provided in the document should be taken into consideration by all the parties involved in operations with medical devices allowed for marketing and use in Singapore including the ones who register, manufacture, import, and supply medical devices (collectively referred to as “dealers”).

Terms and Definitions 

First of all, the document provides definitions of the most important terms and concepts used in the context of medical device recalls, apart from the ones addressed in the Health Products Act (Act) and Health Products (Medical Devices) Regulations (Regulations). These definitions include, inter alia, the following ones:

• Importer – a person who causes the medical device to be brought into Singapore;
• Removal – the physical removal of a medical device from the location where it was supplied to, to some other location for repair, modification, adjustment, relabelling, destruction or inspection. 
• Wholesaler – a person who supplies the medical device by wholesale in Singapore. 

Responsibilities of Registrants and Dealers 

The document further outlines the responsibilities of the main parties involved in operations with medical devices when a recall is initiated. 

First of all, they should notify the authority about a recall before commencing further actions. In order to satisfy this requirement, they should submit information about a recall within 24 hours from the moment the appropriate decision has been taken. Furthermore, within 24 hours from the commencement of a recall, a preliminary report should be submitted. The recall is expected to the completed within 21 days from the date it was commenced, so the final report should be submitted within the same timeframe. 

As it was mentioned before, the parties conducting operations with medical devices are also obliged to develop and implement documented procedures addressing the matters related to recalls. According to the guidance, the appropriate procedure should outline:

• All external and internal personnel involved, along with their functions and responsibilities;
• Channels and means of communications for executing the recall;
• The level of priority and timeframe for completion of the recall. 

The authority further explains that the said documented procedure should describe the approach to be applied when developing a recall strategy based on case-specific circumstances, while all the personnel involved should be properly trained. In order to assist the parties involved in following the said requirement, the authority provides a list of aspects to be covered in one of the appendixes hereto.

Recall Strategy 

The document also provides additional clarifications and recommendations regarding the recall strategy, defined as a detailed plan for implementing a company’s recall procedure in a specific case. According to the guidance, the said plan should address the following aspects:

1. Depth of recall, determined based on the hazard and extent of distribution (could be on consumer/user, retail or wholesale level).
2. Recall communications to be issued in order to ensure the parties involved in operations with an affected medical device are duly notified of the recall and are aware of the actions to be taken. According to the guidance, the registrant and dealers of medical devices are responsible for promptly notifying each of its consignees about the recall. At the same time, the authority additionally emphasizes that when issuing a recall communication, a party responsible for a medical device should neither misrepresent the level of risk nor advertise medical devices.
3. Effectiveness checks should be duly conducted in order to ensure the recall objectives are duly achieved. Methods to be applied include, inter alia, personal visits, phone calls or letters. 
4. Stock control. In order to avoid a mix-up, a party conducting a recall should take all the measures ensuring the recalled devices will not be supplied again unless the necessary corrective actions are taken. 

Procedure’s Elements 

As it was mentioned before, the present guidance contains an annex outlining the key elements of a documented procedure to be developed and implemented by the parties responsible for medical devices. According to the guidance, the said procedure should include the following roles:

• Receive evidence of unsafe medical devices;
• Company to assess risk and prepare action plan;
• Notify and submit report to the authority;
• Send communication to consignees; 
• Submit follow-up report to authority, if required;
• Arrange for collection of affected stocks or any necessary action;
• Quarantine all affected stocks;
• Submit final report to authority.

In summary, the present HSA guidance provides an overview of the existing regulatory requirements in the sphere of medical device recalls. The document highlights the key points to be considered by the parties responsible for medical devices and outlines their main obligations. 

Sources:

https://www.hsa.gov.sg/docs/default-source/medical-devices/gn-04-r2-2_guidance-on-medical-device-recall(17nov-pub).pdf

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