The article highlights the most important aspects associated with the declaration of conformity to be issued by a party responsible for a medical device to demonstrate compliance with the applicable safety and performance requirements.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, including medical devices, has published a guidance document dedicated to the Declaration of Conformity (DOC) and specific aspects associated thereto. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, so in case of any discrepancies with the respective provisions of the underlying legislation, the latter should prevail. Hence, the authority does not make any statements regarding the completeness or accuracy of the statements the document contains, and also encourages the engagement of regulatory compliance specialists when following the approach outlined in the guidance.
Under the existing framework, one element of a global regulatory model for medical devices is that the product owner attests that its medical device complies fully with all applicable Essential Principles for Safety and Performance and draws up a written DOC.
The scope of the guidance covers any medical devices that are intended to be marketed and used in Singapore.
According to the guidance, the Declaration of Conformity should be drawn up in English and contain the following elements and components:
- An attestation confirming that the product in question is fully compliant with the respective Essential Principles for Safety and Performance; and has been duly assigned to the appropriate class under the applicable risk-based classification system.
- Information is sufficient to identify the products covered by the scope of the Declaration.
- Indication of a risk class the device is assigned to.
- Information about the entity responsible for a medical device.
- Details regarding the applicable standards, including the ones related to quality management.
- Details of a responsible person authorized to sign the DOC on behalf of the entity responsible for the device, including the indication of the name and position of such person.
The authority additionally emphasizes that the Essential Principles for Safety and Performance of medical devices should be applied concerning any medical devices intended to be marketed and used in the country and falling within the scope of the Health Products (Medical Devices) Regulations 2010.
As further explained by the HSA, a Declaration of Conformity should be prepared and signed by an authorized person to be appointed by the party responsible for a medical device. According to the guidance, the said person should duly sign a Declaration of Conformity in paper format, and then provide the authority with a scanned copy, while the paper copy should be made available once requested by the HSA.
To assist medical device manufacturers and other parties involved with preparing a Declaration of Conformity, the authority provides an example of a Declaration to demonstrate the way the document should be drafted, and also to highlight the key points to be taken into consideration. In this respect, the authority emphasizes the following:
- A Declaration should be printed on the letterhead of the entity responsible for the medical device in question.
- A Declaration should contain a statement whereby the product owner explicitly confirms and assures that the medical device it is responsible for is fully compliant with any applicable regulatory requirements, including the Essential Principles for Safety and Performance as set forth by the respective regulations.
- The document should contain a detailed enough description of the manufacturing facilities involved in the manufacturing process.
- It is also necessary to provide information about the medical device in question, including its name, and model number, and indicate the class of the device under the applicable risk-based classification accompanied with a reference to the respective classification rule.
- In terms of the Quality Management System, it is important to provide the details regarding the certificate issued (including the name of the certification body, the number of the certificate, and also the dates when it was issued and when it will expire). The authority additionally emphasizes that for Class B, Class C, and Class D medical devices, declaration of conformity to either of the following QMS standards is mandatory: ISO 13485, US FDA Quality System Regulations, and Japan MHLW Ordinance 169.
- The document should also contain references to the applicable international standards.
- As it was mentioned before, a Declaration of Conformity should be dated and duly signed by an authorized person appointed by the manufacturer or other party responsible for a medical device.
In summary, the present HSA guidance describes the regulatory requirements to be followed when preparing a Declaration of Conformity – a document to be issued by the party responsible for a medical device intended to be marketed and used in Singapore to confirm compliance with the applicable requirements the product should comply with due to its class under the existing risk-based classification. The document outlines the most important aspects to be considered in terms of the structure of a Declaration and its content. In particular, the document indicates the elements to be included in a Declaration, and also explains the way it should be prepared and submitted to the HSA for review. The guidance also provides references to the underlying legislation and other guidance documents issued by the HSA and dedicated to the related matters (e.g., GN-16 Guidance on Essential Principles for Safety and Performance of Medical Devices).
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