In Singapore, the person responsible for the registration of medical devices is an important legal requirement to ensure that medical devices are legally available for sale and use in the market. Here are some key facts about those responsible for medical device registration:
Regulatory requirements: Singapore's Health Sciences Authority (HSA) is the main body responsible for regulating medical devices, under the Health Products Act and the Health Products (Medical Devices) Regulations regulations, all companies selling medical devices in Singapore must appoint and register a local registration officer.
The role of the registration principal: The Registrar is the authorized representative of the medical device company in Singapore and is responsible for communicating with the HSA and fulfilling all legal obligations. They are responsible for ensuring that the company's medical devices comply with regulatory requirements in Singapore, including product registration, license application, quality control, safety and performance evaluation, etc.
Eligibility Requirements: The registered responsible person usually needs to be a Singapore citizen or permanent resident and must reside in Singapore. In addition, they must have relevant expertise and experience in order to perform their duties effectively. They also need to be up-to-date on the latest changes in Singapore's medical device regulations and policies.
Application Process: When a medical device company registers as a responsible person in Singapore, it is usually required to provide some key information, including the personal particulars, background information, relevant qualifications and experience of the registered person, as well as the company's details. The HSA will review this information and decide whether to approve the application of the Registrar.
Oversight and complianceOnce approved by the Registrar, they will be responsible for overseeing the medical device company's business, ensuring that the company's products are compliant and meet all regulatory requirements. They also need to stay in close contact with HSA to assist with product issues, recalls, complaints, etc.
Notice of ChangeIf the company decides to change the person in charge of registration, it must submit a notice of change to HSA in advance and complete the replacement of the person in charge of registration within a certain period of time after the change.
In conclusion, medical devices need to have a person in charge of registration in Singapore to ensure the legality and compliance of the medical device company in Singapore. The Registrar is responsible for communicating with the HSA and complying with all legal obligations to ensure that the medical device complies with regulatory requirements. They need to have the relevant qualifications and experience, and they need to work with HSA on a regular basis to ensure that the company's business continues to be compliant. Therefore, medical device companies must carefully comply with this regulatory requirement in Singapore to ensure that their products are legally sold and used in the market.