The Health Sciences Authority of Singapore ("HSA") recently announced two new schemes for medical devices in Singapore: Pre-Market Consultation Scheme ("PMCS") and Priority Review Scheme ("PRS"). In the PMCS, companies would be able to conduct consultations with the HSA during the device development and pre-submission phases to understand the regulatory requirements, which had not been available before. In the PRS, medical devices that fall under five designated healthcare focus areas, and which are designed and validated to address unmet clinical needs may qualify for priority review. This would allow patients to have earlier access to innovative medical devices. The schemes are tentatively set to be launched in August of 2017.
I. Pre-Market Consultation Scheme
In the PMCS, companies may apply for a Medical Device Development Consultation and/or a Medical Device Pre-Submission Consultation with the HSA. The following table summarises the scope of each consultation, accompanying fees and duration of consultation:
| Consultation Category
|| Fees (SG$)
|| Duration of Consultation
|Medical Device Development Consultation
Requirements regarding device development such as:
- Regulatory strategy
- Device claims
- Safety / Performance studies
- Risk management
- Clinical trials
|$500 per device per consultation
||Up to 2 hours
|Medical Device Pre-Submission Consultation
Requirements regarding the device dossier for submission such as:
- Risk Classification
- Registration Route
- Technical & Administrative Documents
| $200 per device application per consultation
|| Up to 1 hour
The consultations are not meant to be a scientific evaluation of the device and do not guarantee a successful product registration. Appointments can be made via the online Appointment Booking System of HSA. Applicants should make such booking 5 months prior to the consultation and submit the relevant documents 30 days prior to the consultation.
II. Priority Review Scheme
The PRS would allow medical devices that meet both the following criteria to be eligible for priority review.
| Qualification Criteria for Priority Review*
| Criteria 1
The medical device falls under 1 of the 5 health focus areas:
- Ophthalmic diseases
- Cardiovascular diseases
- Infectious diseases
| Criteria 2
The medical device is designed and validated to meet unmet clinical needs, in that it is:
- Intended for a medical purpose with no existing alternative treatment or means of diagnosis; or
- Considered to be a breakthrough technology that provides a clinically meaning advantage over existing technologies
*Class A devices and devices that incorporate registrable medicinal products are not eligible for the PRS.
Procedures to apply for product registration for a medical device have not been changed. Applicants should continue to submit the application via HSA's Medical Device Information and Communication System. Applicants wishing to apply for priority review should select "Priority Review Scheme" in the application and provide evidence to substantiate that the medical device meets criteria 2. The HSA will determine whether the medical device would qualify for the PRS.
Prior to the PRS, priority review was only given to new drug applications. The PRS demonstrates HSA's recognition that medical devices may likewise address unmet clinical needs.
Both the PMCS and PRS are a boon for the medical device industry. The PMCS would allow medical device developers to seek guidance on complex regulatory requirements early in a device’s development cycle. Further, the PMCS could be a useful platform for companies to consult the HSA on ‘grey areas’ in the regulatory framework that may arise from advances in technology. The PRS allows developers an accelerated evaluation and approval route provided that two key criteria are met. The introduction of the PMCS and PRS reflects HSA's dedication to support the growth of the medical technology industry (also known as "medtech") in Singapore.
This article is produced by our Singapore office, Bird & Bird ATMD LLP, and does not constitute legal advice. It is intended to provide general information only. Please contact our lawyers if you have any specific queries.