Medical devices are regulated by the Health Products Act (the “Act”) enacted in 2007 and the Health Products (Medical Devices) Regulations 2010 (the “2010 Regulations”) which came into operation on 10 August 2010. Before the Act, medical devices generally, were not regulated by legislation.
A “medical device” is defi ned to include a range of instruments used for health purposes such as for the diagnosis, prevention, monitoring of disease or injuries, support of life, or provision of medical information and other medical purposes, but which does not achieve its purposes through pharmacological, immunological or metabolic means.
Some changes to the regulation of medical devices brought about by the 2010 Regulations are:
1. The Act requires a manufacturer to hold a manufacturer’s license, a wholesaler to hold a wholesaler’s license and an importer to hold an importer’s license. However, manufacturers, importers and wholesalers (collectively, the “suppliers”) are not required to hold licenses in the following scenarios:
- At the request of a qualifi ed practitioner, private hospitals, medical clinics or healthcare establishments can, manufacture and supply custommade medical devices without a license and supply such unregistered health products for the use of any patient.
- A qualified practitioner is a registered medical practitioner (defi ned under the Medical Registration Act to be a person who is registered with the registrar of the Medical Council), when acting in the course of providing medical treatment to a patient under his care, or a registered dentist (defi ned under the Dental Registration Act to be a person who is registered with the registrar of the Singapore Dental Council).
- A manufacturer’s license is not required if a medical device is “manufactured by secondary assembly” before 1 August 2011, but a licence will be required after 1 August 2011.
- Secondary assembly means the process of repackaging a medical device from its original packaging into another packaging, without any breach of the primary packaging before the medical device is sold or supplied.
- A manufacturer who also wholesales its own medical devices, is required to hold only a manufacturer’s license and is not required to hold a wholesaler’s license.
- A supplier must not supply any health product that is not registered with the Health Sciences Authority of Singapore (the “HSA”) with the following exceptions:
- where the medical device is merely refurbished and returned, at the request of a private hospital, medical clinic, clinical laboratory or healthcare establishment who owns the device;
- where private hospitals, medical clinics or healthcare establishments manufactures and supplies custommade medical devices at the request of a qualifi ed practitioner;
- where a medical device is manufactured solely for export or imported for the sole purpose of re-export; or
- where the medical device is imported, supplied or used for a non-clinical purpose and the supplier has been granted a license for that same purpose.
2. Periodic testing may be carried out on the supply of medical devices by HSA.
3. Trade descriptions and labelling of medical devices must not be false or misleading, and sufficient information on the medical device must be provided on the device itself or the packaging of the medical device.
4. Advertisements of medical devices must contain only statements that can be verifi ed by objective evidence or facts.
5. Medical devices are divided into classes for the purposes of the Act and for registration.
- For example class A medical devices pose a low health risk to an end user of the medical device. Class A medical devices are non-invasive in nature and are not intended to come into contact with injured skin and used principally with wounds which have breached the dermis and cannot heal by primary intention.
- Class D medical devices pose the highest health risk on the end user and include invasive medical devices used specifi cally in direct contact with the central nervous system, or for the diagnosis monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body.
6. HSA may, on the application of a manufacturer, issue certifi cates including:
- a certificate of origin certifying that the medical device is manufactured in Singapore and if so required, registered under the Act;
- a certificate of registration where the HSA has registered a medical device, including a hardcopy of the certifi cate where requested;
- a certificate of free sale, certifying that the medical device is registered under the Act and may be supplied in Singapore without any restrictions.
7. Manufacturers and importers have duties, including to:
- comply with conditions of licenses or registration;
- maintain records;
- report defects or adverse effects of the medical device to HSA within the stipulated time period; and
- notify HSA of intended recall or a medical device at least 24 hours before the recall.