HSA Enables Faster and Expedited Access for Lower Risk Medical Devices through Enhancements to its Regulatory Framework

The Health Sciences Authority (HSA) announced today that its regulatory framework will be enhanced for lower risk Class A and B medical devices, to facilitate expedited access and lower regulatory fees for these products. Class A and B devices account for about 70% of all medical device applications received by HSA.Further enhancements are also being planned for the higher risk Class C and D devices. The enhanced regulatory framework seeks to better address the concerns of the medical device industry while ensuring patient safety. HSA will continue to risk stratify the regulation of medical devices based on international best practice, while allowing greater customisation and flexibility in each class through judicious referencing of key overseas agencies and history of safety.

Faster and Expedited Access for Lower Risk Devices

2      HSA will be exempting all Class A devices from registration except for sterile devices from 1 May 2012. This will cover an estimated 80% (approx 4,700) of Class A product types, and importers/manufacturers will only be required to list the medical devices with HSA to facilitate post-market surveillance and monitoring.There will be no registration fee for exempted Class A devices.

3      For Class B medical devices, HSA will be implementing the following new routes on 1 September 2012:

(i) Immediate Registration Route

Immediate access for Class B medical devices that have already been approved by two of HSA's independent regulatory reference agencies [1], and marketed without any safety concern for at least three years in these jurisdictions.

(ii) Expedited Registration Route

Devices qualifying for this route are:

a. Class B devices which have already been approved by two of HSA's independent regulatory reference agencies; or

b. Class B devices which have already been approved by at least one of HSA's independent regulatory agencies and marketed in this jurisdiction or Singapore without any safety concerns for the past three years.

The medical devices that qualify for the Expedited Registration Route will see approval time being reduced from 100 to 60 working days.

4      For the Immediate and Expedited Registration routes, the regulatory fees will be reduced from $2,300 to $1,400 as the time and manpower needed to evaluate these products are correspondingly lower. An estimated 3,650 Class B applications will be eligible for these routes and represent 85% of Class B applications.

Further Initiatives

5      In addition, HSA is looking into a lower tiered fee structure for its Special Authorisation Route to take into consideration both existing and innovative, low cost and low volume medical devices to meet the continued medical needs of patients. This will be implemented on 1 August 2012 after reviewing the key products of concern with dealers and healthcare professionals.

6      Further enhancements are also being planned using the agency referencing approach for the higher risk Class C & D devices.

7      “Given the pervasive use and rapid technological advances of medical devices at all levels of health care delivery,patient safety remains the top priority for HSA. These changes reflect a flexible and responsive regulator that is willing to listen to the teething issues faced by the industry with the introduction of medical device regulation in Singapore, without compromising patients' well being. I am confident that these enhancements, in particular, for lower risk devices, will address the concerns of industry and that HSA will continue to enhance the framework to facilitate access to safe medical devices,” said Dr Amy Khor, Minister of State (Health).

Greater Emphasis on Post-Market Measures

8      “We appreciate the feedback received on issues faced by the industry and healthcare professionals. HSA has therefore made enhancements to its risk-based framework to better address these concerns through more judicious referencing of key regulatory agencies.This will facilitate faster access to new low risk medical devices, without compromising patient safety. We will manage risk by putting more emphasis on post-market vigilance, compliance, audit and enforcement,” said Associate Professor John Lim, CEO of HSA.

Cooperation with SMa

9      To address the issues faced by industry, HSA is in discussion with the Singapore Manufacturers' Federation (SMa) to pilot a project to provide training to companies on dossier submission, as well as a “concierge service” to help screen the completeness and appropriate risk classification of dossier applications to HSA.

10     The HSA-SMaRT Dossier Submission E-Guide will also be launched today on HSA's website. The E-Guide will provide industry with clearer step by step advice on dossier submission.

11     These initiatives will potentially help minimise delays due to incomplete submissions and documentation.

Extensive Consultation with Industry

12     The above changes and initiatives are the result of extensive engagement and consultation with the industry and healthcare professionals. HSA has had more than 60 communication sessions and workshops to help guide and explain the MD regulations to stakeholders over the past 4 years. In anticipation of issues that might arise in the final phase of implementing mandatory medical device regulation on 1 Jan 2012, HSA also initiated intensified engagement through 9 focus groups and dialogue sessions with doctors, dentists, medical device industry associations and hospitals' purchasing departments.

13     The feedback received has allowed HSA to understand key issues faced by stakeholders and craft the enhancements announced today. HSA will continue to engage its stakeholders to further enhance the medical device regulatory framework.

HEALTH SCIENCES AUTHORITY
SINGAPORE
20 APRIL 2012

^{[1]US FDA, EU Notified Bodies/Australian Therapeutic Goods Administration, Health Canada & Japan Ministry of Health, Labour and Welfare}

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