SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
Medical Devices Ongoing obligations for registrants of medical devices include: • ensuring and maintaining objective evidence to establish that the medical device complies with safety and performance requirements; • maintaining records of every supply of the medical device; • maintaining records of complaint reports and of actions taken in response to these reports; • reporting defects in the medical device or adverse effects arising from the use thereof; • reporting information that adversely affects the validity of any data furnished to the HSA relating to the quality, safety or efficacy of the medical device; • notifying the HSA prior to any intended recall and furnishing a report of that recall; and • notifying the HSA prior to carrying out any field- safety correction in relation to a medical device and furnishing a report thereon. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations The Health Products (Medical Devices) Regulations 2010 and Health Products (Therapeutic Products) Regulations 2016 allow the disclosure of information relating to applications for registration. Trade secrets and information of commercial value that would be, or would be likely to be, diminished by disclosure are excluded from any such disclosure requirements. The HSA makes publicly available, on an online data- base, information submitted to it in support of health product registration applications for registered health products. Information relating to pending applications is currently not publicly available. Confidentiality Disclosure of any confidential information obtained in the administration or enforcement of the HPA is gener- ally prohibited, except with the consent of the person from whom the information was obtained. However, the HSA may disclose any confidential information relating to the quality, safety or efficacy of a thera- peutic product or medical device if the disclosure is, in the HSA’s opinion, necessary to protect the health
or safety of members of the public, or if the disclosure is to a government body. In addition, confidential supporting information given in relation to an innovative therapeutic product appli- cation is protected by the HSA for a period of five years after the application is received by the HSA, subject to exceptions. An innovative therapeutic prod- uct application can be made for a substance that is an ingredient in the manufacture or preparation of the therapeutic product to which the application relates and that has not been referred to as an ingredient in the manufacture or preparation of any other therapeu- tic product in any previous application. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Therapeutic Products Depending on the type of therapeutic product and whether it has been approved by any overseas drug regulatory agencies, different evaluation routes apply for the registration of a therapeutic product. For instance, if a therapeutic product has been approved by the HSA’s reference drug regulatory agencies – ie, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Health Canada (HC), the UK Medicines and Healthcare prod- ucts Regulatory Agency (MHRA), Swissmedic or the Australia Therapeutic Goods Administration (TGA) – it will be assessed under the verification evaluation route, which is subject to the lowest fees among the evaluation routes and has the shortest turnaround time. Medical Devices Similarly, different evaluation routes apply for the reg- istration of a medical device, depending on the class of medical device and whether it has been approved by any overseas referenced regulatory agencies. For instance, if a Class B, C or D medical device has received approval from at least one of the HSA’s over- seas reference regulatory agencies, it will be assessed under the abridged route.
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