The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the procedures and processes associated with medical device product registration. The initial article on the matter describes the applicable requirements for registration of Class A and B medical devices, while the present article addresses the regulatory matters related to the registration of Class C and D medical devices.
The document is intended to provide medical device manufacturers and other parties involved in placing medical devices on the country’s market with additional clarifications regarding the applicable regulatory requirements set forth under the current legislation.
Table of Contents
Evaluation
First, the document describes existing evaluation routes for Class C and D medical devices, namely:
- Full Evaluation Route,
- Abridged Evaluation Route,
- Expedited Evaluation Route,
- Expedited Class C Registration (ECR)
- Expedited Class D Registration (EDR)
- Immediate Class C Registration (ICR) Evaluation Route [solely for Standalone Medical Mobile Applications].
The authority additionally emphasizes that special accelerated pathways intended to facilitate placing medical devices on the market and reduce the time necessary to complete the appropriate regulatory procedures could be applied only for medical devices approved by the authority and/or having prior safe marketing history. In terms of approvals granted by foreign national regulating authorities in the sphere of healthcare products, the HSA recognizes those granted by the Australian Therapeutic Goods Administration (TGA), Health Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW), the US Food and Drug Administration (FDA), and the European Union Notified Bodies (EU NBs) duly designated to carry out conformity assessment under the Directives or Regulations.
The guidance further describes eligibility criteria to be applied with regard to each of the evaluation routes. In particular, the document contains a table providing the following details:
Submission Requirements and Processing the Application
According to the guidance, all information and documents submitted in support of the registration of Class C and D medical devices must be compiled in the ASEAN Common Submission Dossier Template (CSDT) format. If the intended use medical device in question is labeled for actually exceeds its inherent performance, the applicant could also be asked to submit additional clinical data. In case of placing medical devices on the country’s market under one of the accelerated frameworks, medical devices manufacturers should duly keep all necessary documentation in place to be able to provide it to the regulating authority upon request.
As it is described in the document, the application process includes the following steps:
- Submission of application via MEDICS;
- Screening of application;
- Evaluation of application;
- Regulatory decision and listing on SMDR for successful registration.
It is further stated that the application fee should be paid by the applicant immediately upon submission. The HSA also mentions that all applications are subject to preliminary screening in order to evaluate the completeness, as well as eligibility for the particular route. Should the authority determine the route selected by the applicant as inappropriate, it will forward the application to the one it finds suitable. The evaluation of the application will be carried out by the authority by using the documents initially provided by the applicant. Thus, the regulating authority will make its decision using the information provided. However, the authority is entitled to request additional documentation, should it be reasonably necessary to ensure completeness of review.
The calculation of the timeframe should commence once the authority requests the applicant to provide additional information or documentation and stop when a detailed enough response is received.
Additional Aspects
Apart from the key points described above, the document also outlines some additional aspects to be considered by medical device manufacturers intending to place their Class C and D medical devices on the market. First, the authority emphasizes the importance of the manufacturer being familiar with the regulatory requirements applicable for particular routes. According to these requirements, the manufacturer is allowed to submit its application under the appropriate framework, provided it meets any and all eligibility criteria. Under the general rule, an interested party may apply for marketing approval for a single medical device, medical device family, medical device system, or medical device group, provided the relevant eligibility criteria are met.
As mentioned, some medical devices are explicitly excluded from the scope of those eligible for placement on the market under the expedited routes. For such devices, Full or Abridged evaluation routes should be applied.
In summary, the present HSA guidance describes in detail existing regulatory frameworks to be applied when placing Class C and D medical devices on the market. The document provides additional clarifications on eligibility criteria and highlights the most important points to be considered when applying for marketing approval for a medical device in Singapore.
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