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Product Regulation & Liability

Singapore: Release of draft Regulatory Guidelines for Laboratory Developed Tests

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In brief

The Health Sciences Authority’s (HSA) Medical Devices Cluster (MDC) has released draft Regulatory Guidelines for Laboratory Developed Tests (LDTs).

The HSA’s MDC has invited stakeholders to provide feedback on the draft document, with the consultation period being from 12 July 2022 to 12 August 2022.

In more detail

The HSA’s MDC has released draft Regulatory Guidelines for LDTs, which seeks to provide guidance to laboratories on understanding the regulatory requirements applicable to LDTs. In particular, the draft Regulatory Guidelines explain the scope of LDTs and set out an overview of regulatory controls for LDTs, including product controls, manufacturing quality controls and post-market controls.

LDTs are in vitro diagnostic tests (IVDs) that are regulated as medical devices. In particular, they are IVDs that are developed and manufactured within a licensed clinical laboratory and solely for use within the same laboratory where it was developed; and intended for specific clinical diagnostic use. 

Through the Regulatory Guidelines, the HSA’s MDC has sought to provide some examples on what are and are not considered as LDTs. For instance, LDTs do not include the following (amongst others):

  • The use of commercial IVDs for purposes other than the intended use / indications for use specified by the manufacturer; and
  • Use of “research use only” tests or assays by licensed clinical laboratories for clinical diagnostic purposes.

The HSA’s MDC has also provided a brief overview of regulatory controls for LDTs, which is summarised below:

  1. Product controls

As LDTs are developed and used by laboratory professionals with expertise and experience within their own facility, LDTs are not required to undergo product evaluation by or registration with the HSA. Instead, clinical laboratories would be able to notify the list of LDTs that they implement and use in their laboratory at the Ministry of Health’s (MOH) licensing portal.  

  1. Manufacturing quality controls

Clinical laboratories that develop and use LDTs for clinical diagnostic purposes are considered manufacturers. They would already be licensed under the Healthcare Services Act, and therefore not be required to hold a manufacturer’s licence from the HSA.

However, clinical laboratories are required to implement and maintain appropriate quality management systems. This is to ensure that all batches of LDTs manufactured continue to meet consistent quality and performance specifications.

  1. Post-market controls

Clinical laboratories that manufacture LDTs have to comply with post-market requirements prescribed under applicable healthcare regulations, including the reporting of adverse events and field safety corrective actions, including recalls.

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The HSA’s MDC has invited stakeholders to provide feedback on the draft Regulatory Guidelines from 12 July 2022 to 12 August 2022.

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Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

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Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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