The article describes the regulatory procedures to be followed when changing a registrant of a medical device.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to changes to the registrant responsible for a medical device allowed for marketing and use in the country. The document describes in detail the regulatory procedures to be followed, provides additional clarifications regarding the applicable regulatory requirements, and also highlights the key points to be taken into consideration in this respect. At the same time, it is important to mention that the provisions of the document are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. Furthermore, in case of any discrepancies between the recommendations provided in the guidance and respective provisions of the existing legislation, the latter should prevail, so the parties involved are encouraged to request professional legal and regulatory assistance to ensure compliance thereto.
First of all, the document defines a registrant in the context of the medical devices regulatory framework. According to the guidance, a registrant stands for a person who applied for and obtained the registration of a medical device under the Health Products Act (Act). The authority further outlines the duties and responsibilities of a registrant as set forth by the aforementioned Act, and also by the Health Products (Medical Devices) Regulations (Regulations). By the said regulations, these responsibilities include, inter alia, the following ones:
- Comply with the conditions applicable to the registered medical device and conditions imposed on the registrant;
- Submit applications to the Authority for changes made to the registered medical device;
- Maintain records of supply;
- Maintain records of complaints;
- Report defects and adverse effects to the Authority; and
- Notify the Authority concerning field safety corrective action (FSCA), including recalls.
As further explained by the authority, in case of a change to the registrant of a medical device, the appropriate application is to be submitted to the HSA. According to the guidance, the parties participating in this process would be the Relinquishing Company and the Accepting Company. The application to be submitted to the HSA should clearly outline the scope of responsibilities of each of them. It is also important to mention that the HSA will review the application and make a decision to either accept the application submitted or reject it.
Recommendations provided in the guidance could be applied concerning any medical devices allowed for marketing and use in the country.
To assist in interpreting the provisions of the applicable legislation, as well as recommendations contained in the document, the authority also provides definitions of the most important terms and concepts used in the context of medical device registration and changes thereto. The terms explained by the HSA include, inter alia, the following ones:
- Accepting company – the newly appointed registrant by the product owner;
- Relinquishing company – the registrant that has obtained the registration of the medical device and that shall be relinquishing the product registration for the medical device to the Accepting Company.
Apart from the ones listed herein, the document also explains such terms as “field safety corrective action”, “product owner”, “registrant”, and “supply”. For some of the terms, the definitions provided by the Regulation are used.
The document further describes in detail the application requirements to be followed when applying for changes to the registrant for a medical device listed on the Singapore Medical Device Register (SMDR), a country’s register for medical devices. According to the guidance, such an application could be submitted concerning a valid registration, provided there are no pending applications (e.g., change notification), otherwise such pending applications should be either completed or withdrawn. Furthermore, it is stated that for each product owner involved in the process a separate application will be required.
The application described herein should be submitted by the Accepting Company by providing the respective application forms to the authority. According to the document, the overall expected turn-around time (TAT) in such cases will be 40 business days. At this stage, the company applying should make sure the medical device listing subject to changes remains valid for at least for two months following the application date. The aforementioned TAT calculation will commence upon receipt of the complete application by the authority and will be placed on hold in case of additional requests issued by the HSA. It is also stated that the effective date of the change of registrant is the date of approval of the application by HSA.
According to the guidance, the application to be submitted by an interested party for the change of the registrant should include the following documents:
- A letter of authorization to appoint the Accepting Company as the registrant (the document provides a reference to the respective template);
- A letter of request addressed to HSA for the request for the change of registrant from the Relinquishing Company to the Accepting Company;
- Relinquishing Company Declaration Form, duly completed and signed by Relinquishing company.
The authority additionally emphasizes that the Relinquishing Company is responsible for maintaining the records related to complaints. As explained by the HSA, such records could be either maintained by the initial registration holder or transferred to a new one.
In summary, the present HSA guidance provides an overview of the applicable regulatory requirements in terms of applying for changes to the medical device registration holder. The document describes the application process and highlights the key points to be considered.
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