Singapore Medical Device and Pharmaceutical Regulations

Singapore’s Health Sciences Authority (HSA) is tasked with regulating drugs, innovative therapeutics, medical devices, and other health products to meet appropriate safety, quality, and efficacy standards, as well as contributing to the development of national drug policies. The HSA evaluates product registration applications, assesses clinical drug trials, and audits good manufacturing and distribution practices in order to grant approvals that allow products to be marketed in Singapore. In the post-market phase, the HSA conducts regulatory surveillance on medical products, enforces actions against illegal activities, and responds to adverse drug events.

The Health Products Act

Implemented in 2007, the Health Products Act regulates the registration, manufacture, import, supply, storage, packaging, and advertisement of all health products in Singapore, including therapeutic products (commonly known as western pharmaceutical drugs), medical devices, and cosmetics. All pharmaceutical and medical device products must be registered with the HSA before they can be sold in Singapore.

When applying for product registration in Singapore, foreign companies must appoint a Singapore-based entity as their Registrant–the company that applies for and holds the registration of the medical device. This Singapore-based entity can be the foreign company’s local office or a local Singaporean company that the foreign company partners with, as long as the company is registered with the Accounting and Corporate Regulatory Authority (ACRA) of Singapore.

The registration process for all products is conducted through the online Medical Device Information and Communication System (MEDICS).

Singapore’s Medical Device Regulations

For medical device registrations, the Registrant is required to obtain a dealer’s license from the HSA, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. Applicants can apply for product registration and the dealer’s license at the same time.

In Singapore, medical devices are classified as either Class A, B, C, or D. Class A devices include simple, low risk tools such as tongue depressors while Class D are complex, high risk objects such as heart valves. All Class A medical devices are exempted from product registration and are to be declared in the public online Class A database. Class B, C, and D devices require registration.

The Singapore Medical Device Register (SMDR) is a database that contains a list of all medical devices that are currently being used on patients. The database is openly accessible by anyone and the public can search for devices by using the device name, product owner, identification number, or hospital.

Singapore’s Pharmaceutical Regulations

When registering a therapeutic product, applicants should consider what application type and evaluation route to choose, as well as the need to attend a pre-submission consultation with the HSA.

The HSA distinguishes between chemical or biological therapeutic products. In addition, there are two categories of applications: new drug application (NDA) and generic drug application (GDA). A GDA applies to a chemical product that is essentially the same as a currently registered product in regards to its composition of active ingredients, dosage form, and clinical indication. A GDA does not apply to biosimilar products, which must be submitted via a NDA.

When registering a new therapeutic product, there are four possible evaluation routes:

• Full route – for new products that have not been approved by any regulatory agency
• Abridged route – for new/generic products that have been approved by at least one regulatory agency
• Verification route – for new/generic products that have been approved by HSA’s reference regulatory agencies (EMA4, US FDA, Health Canada, TGA and UK MHRA5)
• Verification-CECA route – for generic products manufactured in India that have been approved by HSA’s reference regulatory agencies (EMA4, US FDA, Health Canada, TGA and UK MHRA5)

The HSA encourages applicants to schedule a pre-submission consultation meeting if they have any questions or concerns regarding their product’s eligibility for an application type or evaluation route, or the adequacy of their application dossier.

For more detailed information about registration requirements and the regulatory pathway for medical devices and pharmaceuticals in China, please see Medical Device Registration in Singapore and Pharmaceutical and API Product Registration in Asia.

Singapore Medical Device and Pharmaceutical Regulatory Resources

For more free information and resources on the Asian medical device and pharmaceutical regulations and healthcare markets, please check out our Resource Center and Blog.