History and overview
The Health Sciences Authority (HSA) is a government organization in Singapore that falls under the Ministry of Health. The HSA performs three primary roles: it acts as the national regulatory approval authority for all health products, manages the national blood supply including the blood bank and transfusion medicine standards, and offers expertise in areas like forensic medicine, forensic science, and analytical chemistry testing.
Established on April 1, 2001, HSA was created by merging five specialized agencies under the Ministry of Health, including the Centre for Drug Evaluation, the Institute of Science and Forensic Medicine, the National Pharmaceutical Administration, the Product Regulation Department, and the Singapore Blood Transfusion Service.
In February 2022, HSA achieved a significant milestone by becoming the world’s first regulatory authority to reach the highest maturity level (ML 4) in the World Health Organization’s classification for medical product regulatory bodies. This means that the WHO considers the HSA to have attained the highest level of medical regulatory excellence.
HSA medical device registration
The HSA oversees the regulation of medical devices within Singapore in accordance with the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010.
Companies are mandated to secure a dealer’s license from the HSA before engaging in the manufacturing, importing, or distributing of medical devices. For the distribution of all medical devices in Singapore (except for Class A devices, which are exempt from registration), they must first be registered with the HSA, unless approved under specific conditions.
Prior to distributing your medical device in Singapore, it is essential to complete the Singapore medical device registration process. The specifics of the registration process will vary based on the risk classification of your device and the appropriate pathways. Medical devices are categorized into risk classes:
1. Class A: Minimal risk (e.g., wheelchairs, tongue depressors)
2. Class B: Low to moderate risk (e.g., hypodermic needles, suction equipment)
3. Class C: Moderate to high risk (e.g., ventilators, bone fixation plates)
4. Class D: High risk (e.g., heart valves, implantable defibrillators).
There are four registration pathways:
1. Full Evaluation Route: This route is for medical devices that lack prior approvals from regulatory bodies in the US, Europe, Canada, Australia, or Japan during the registration application. The process takes 160-310 days.
2. Abridged Evaluation Route: Medical devices already approved in the US, Europe, Canada, Australia, or Japan can take this route, with a registration duration of 100-220 days based on the class.
3. Immediate Registration Evaluation Route (IBR): This route offers immediate registration upon submission, contingent on specific eligibility criteria being met. For Class B devices, the Immediate Route can be used if approved in one overseas country for at least 3 years with no safety concerns or approved in two countries with a clean record.
4. Expedited Registration Route (ECR): The ECR takes 120-180 days for registration and requires devices to meet specific eligibility criteria. This route is generally for class C and D devices with overseas approval.
HSA pharmaceutical product registration
In Singapore, the HSA oversees drug products through the Health Products Act (HPA) and its associated regulations, including the Health Products (Therapeutic Products) Regulations 2016.
It is mandatory for companies to secure a dealer’s license prior to engaging in activities such as manufacturing, importing, or supplying. Additionally, all therapeutic products must undergo registration with the HSA before they can be distributed in Singapore.
In Singapore, pharmaceutical drugs are categorized as follows:
1. Prescription-only medicines (POMs): Require a doctor’s prescription for dispensing.
2. Pharmacy-only medicines (P): Available at retail pharmacies, suitable for self-recovering conditions (conditions that can be resolved without any serious treatment)
3. General sale list (GSL): Can be freely purchased without restrictions, and considered safe for the general public.
The drug registration process with the HSA is outlined below.
1. Preliminary Preparation:
Gather essential application documents and consider consulting the HSA for guidance through inquiries or consultation sessions.
2. Application Submission:
Utilize the Pharmaceutical Regulatory and Information System (PRISM), Singapore’s online platform, to complete the application form. Submit the comprehensive drug dossier within 2 business days after submitting the PRISM form.
3. Application Screening:
The HSA will review the application to confirm the inclusion of required documents. Applicants must address any information requests from the HSA within 20 business days; failure to comply will result in application rejection.
4. Evaluation and Decision:
Following the completion of the application and fulfillment of information requests, the HSA will evaluate the submission and make a decision.
The HSA’s decision processing times for pharmaceutical registration in Singapore differ based on the evaluation dossier type:
– Full evaluation dossiers: 270 working days
– Abridged evaluation dossiers: 120-240 working days
– Verification evaluation dossiers: 60-120 working days
However, if the HSA needs more information, these times may be extended.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://www.hsa.gov.sg/