SINGAPORE MEDICAL DEVICE REGULATION
The Health Sciences Authority (HSA) is the authority responsible for the regulation of medical devices, medicines, national blood banks and public services established on 1 April 2001. To register a medical device in Singapore, you must first be registered locally in Singapore. with the Accounting and Corporate Regulatory Authority (ACRA), those who can apply for licenses and register medical devices. Especially for class A medical devices that are exempt from product registration. If already registered with the Accounting and Corporate Regulatory Authority (ACRA), the company must create a Client Registration and Identification Company (CRIS) account at the Health Sciences Authority (HSA). For companies to access the online MEDICS portal.
Medical Device Information and Communication System (MEDICS) is a special portal for online product registration transactions or future updates.Accounting and Corporate Regulatory Authority (ACRA) is a legal council under the minister of finance Singapore government in charge of regulating business registration, financial reporting, public accounting, and company service providers, was formed on April 1, 2004Once the CRIS account is ready, companies can apply for dealer licenses simultaneously according to their activities such as Manufacturer's license, importer's license or wholesaler's license (import and export. Only companies with registrant accounts can register medical devices in Singapore.
Post Market Surveillance (PMS) is surveillance for all events that occur in products in Singapore under the Health Products Law and Health Product Regulations 2010. Companies/product owners are required to carry out Post Market Surveillance (PMS) based on the ASEAN Medical Device Directive (AMDD) rules. which took effect on January 1, 2015. Medical device manufacturers are required to be diligent in reporting Adverse Events (AEs) and distributors are responsible for reporting AEs. HAS does not require to submit AE reports for events outside Singapore except for the possibility of fatal or serious injury.
Adverse Events (AEs) can be reported if three criteria are met, such as:
- There have been Adverse Events (AEs)
- The association of medical devices with Adverse Events (AEs)
- Adverse Events (AEs) leading to a serious threat to public health, Death of a patient, Serious deterioration in the health condition of the user or others, or An event that can cause fatal injury or death to the user or patient.
HSA steps in Post Market risk assessment:
- Exchange of information with medical device regulatory agencies in other ASEAN member countries;
- Reporting obligations of medical device distributors (economic agents such as producers and distributors);
- And reporting from health professionals
The companies involved must keep data on complaints received and a record is made for HSA to examine. The data created must contain information in accordance with the Regulation of the Law on Health Products (Medical Devices), 41.
Adverse Events (AEs) reporting has a certain time limit:
- Serious threats to public health must be reported within 48 hours at the latest
- For events that cause death or serious deterioration of health must be reported within 10 days at the latest
- For events that can result in death or serious deterioration of health due to relapse must be reported within 30 days at the latest.
Field Safety Corrective Action (FSCA) is action taken to reduce the risk of death or serious exacerbation of conditions associated with the use of medical devices, by performing:
- Return of medical devices to the product owner,
- Replacement or destruction of medical devices,
- All actions related to the use of medical devices are carried out according to the instructions of the device owner,
- Permanent or temporary changes to medical device labels or user manuals,
- Clinical management of each patient who has used a medical device,
- Modification of medical devices.
- Medical device modifications are subject to design changes or changes by the device owner.
- Software updates used in medical devices, including remote upgrades.
For medical devices that have been manufactured, imported or supplied in Singapore and medical devices that have been registered or specifically authorized for local supply, the FSCA can report. The reporter must be a retailer or product registrar that manufactures, imports, and supplies the equipment in question. If multiple traders are involved, each trader must report to the FSCA individually.
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There are risk factors posed by the device that can affect the classification of the device such as the duration the device is in contact with the body, the degree of invasiveness, whether the device delivers drugs or energy products to the device. patient, whether it is intended to have a biologic effect on the patient, and local versus systemic effects.
Medical devices and IVD are classified into 4 classes based on the risks that arise according to the attachment of the ASEAN Medical Device Directive (AMDD):
- Class B (Low to Moderate Risk)
- Class C (Medium to High Risk)
- Class C (Medium to High Risk)
GROUPING
In applying for registration of medical devices and IVD in Singapore, it can be grouped according to category, to help save costs and processing time. Grouping can be done if the Products come from the same owner, have a common purpose of use, are used in combination to achieve the same purpose of use and the specific requirements that apply are met for individual categories.
There are several categories in the grouping of medical devices and IVD and some rules are as follows:
- IVD ClusterIVD reagents or items with the same product owner are only included in risk category B with the general test method and are included in the same IVD cluster category.
- IVD Test KitReagents or products with the same product owner are intended to be used in combination for the specific purpose for which they are intended. They are sold as single test kits or labeled for use with IVD test kits.
- Single: Medical devices are sold in different packaging units and can also be supplied in different package sizes.
- Group: A set of two or more medical devices labeled and provided in one package for their common purpose.
- System: Medical devices with the same product owner intended for general purpose use and sold under a unique system name or label or labeled for use with the system
- Family: Medical devices share a common product owner and purpose, as well as a design and manufacturing process. Variants must be within the permitted variations.
- In vitro fertilisation (IVF) media: IVF multimedia medical devices with the same product owner are compatible when used together and used for IVF procedures and belong to the same IVF class.
- IVD analysers: The IVD analysis tools have the same product owner, the same asset name, the same risk classification, and the same method, with allowed variations.
- Fluorescence in situ hybridisation (FISH) probes IVD: Reagents and accessories from the same product owner belong to the same risk class B or C, based on the FISH methodology and under the same FISH Subheading IVD investigation.
- Immunohistochemistry (IHC) IVD reagents: IVD reagents and accessories from the same owner belong to the same hazard class B or C, according to the IHC method, and are in the same IHC classification category.
- Hearing aids: Hearing aids from the same owner with a Class B hazard classification with the same design, audio amplification and communication technology.
- Dental Grouping Terms (DGT): Dental equipment belonging to the same product is classified as dangerous class B, whose intended use is included in the description of the single tooth classification term.
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