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Singapore – Amendments To Health Products (Medical Devices) Regulations.

27 April, 2012

 

Legal News & Analysis – Asia Pacific – Singapore – Regulatory & Compliance

 

INTRODUCTION

 

Following the introduction of the Health Products Act in February 2007, the Health Sciences Authority (“HSA”) has continued to strengthen its regulatory framework through the implementation of the Health Products (Medical Devices) Regulations (“Regulations”). The Regulations, which were introduced in three phases, sets out the mandatory requirements for medical devices in Singapore to ensure that patients have access to safe, good quality and efficacious medical devices.

 

Generally, HSA classifies medical devices (into Class A, B, C or D medical devices) based on their risk of use, which is in turn dependent on a number of factors, including the duration the medical device is in contact with a person’s body, the degree of invasiveness, whether the medical device delivers medicinal products or energy to the patient, and whether the medical device is intended to have a biological effect on the patient.

 

Phase one of the regulatory control for medical devices in Singapore was implemented on 1 November 2007, and required medical device manufacturers and suppliers to keep supply records, report adverse events arising from the use of medical devices, amongst others. On 1 November 2008, phase two of the medical device regulatory control framework was implemented, and HSA began accepting product registration and licence applications for certain classes of medical devices.

 

BACKGROUND

 

Phase three of HSA’s regulatory control framework which provided for the mandatory registration of medical devices came into effect in two stages:

 

(a) on 10 August 2010, in respect of product registration of Class C and D medical devices, and mandatory licensing of medical device dealers; and

(b) on 1 January 2012, in respect of product registration of Class A and B medical devices, resulting in all medical devices being subject to registration requirements, unless specifically exempted.

 

As Class A and B medical devices are generally regarded as low risk and commonly used devices, many members of the medical community, including medical professionals, provided feedback to HSA in relation to their concerns over increased registration costs, cumbersome processes and long approval times.

 

The medical device regulatory framework was revised on 5 April 2012, pursuant to the Health Products (Medical Devices) (Amendment) Regulations 2012, which provided that certain Class A medical devices would be exempt from the registration requirements before they can be imported or supplied.

 

On 20 April 2012, HSA announced further proposed amendments to the regulatory framework for medical devices. In particular, these proposed amendments relate to:

 

(a) expanding the list of exempt Class A medical devices; and

(b) streamlining the registration process for Class B medical devices.

 

PROPOSED KEY CHANGES TO THE REGULATORY FRAMEWORK

 

Amendments to registration of Class A medical devices

 

With effect from 1 May 2012, all Class A medical devices will be exempted from registration, except for sterile devices. This covers approximately 80% or 4,700 of Class A product types. Importers and manufacturer will only be required to list the medical devices with HSA to facilitate post-marketing surveillance and monitoring. No registration fee will be imposed for exempted Class A devices. Amendments to registration of Class B medical devices With effect from 1 September 2012, HSA will be implementing the following new routes for the registration of Class B medical devices:

 

(a) Immediate Registration Route; and

(b) Expedited Registration Route. Product registration fees under both routes will be reduced from $2,300 to $1,400.

 

Immediate Registration Route

 

From 1 September 2012, a new Immediate Registration Route for Class B medical devices will be introduced to allow immediate access to medical devices that have already been approved by at least two of HSA’s independent reference regulatory agencies (ie US Food & Drug Administration; European Union Therapeutic Goods Administration; Health Canada; Japan Ministry of Health, Labour and Welfare) and marketed for at least three years without safety concerns.

 

Expedited Registration Route

 

HSA will also be introducing an Expedited Registration Route, with a turnaround time of 60 working days. Product registration applications will qualify for the Expedited Registration Route if the medical device meets at least one of the two following criteria:

 

(a) approved by at least two of HSA's independent reference regulatory agencies; or

(b) approved by one of HSA's independent reference regulatory agencies and marketed in Singapore or that reference agency’s jurisdiction, for at least three years without safety concerns.

 

Miscellaneous Amendments

 

In addition to the changes in registration for Class A and B medical devices, HSA is also looking into a lower tiered fee structure for its Special Authorisation Route (“SAR”). The SAR is designed for innovative, low-cost and low-volume devices. HSA will be implementing the new fee structure on 1 August 2012, after reviewing the key products with dealers and healthcare professionals.

 

COMMENTS

 

It can be seen from the recent steps taken by HSA that it is seeking to have regard to valuable industry feedback, whilst having patient safety as paramount importance. As noted by HSA, patient safety remains the top priority for the regulator, given the pervasive use and rapid technological advances of medical devices at all levels of health care delivery. As such, whilst HSA has removed the registration requirements in relation to Class A medical devices (save for those with sterile use), it has not removed the registration requirements for Class B medical devices, although it is seeking to introduce an amended registration route for such medical devices.

 

REFERENCES

 

Please click on the following links to access the documents.

 

1. Health Products (Medical Devices) (Amendment) Regulations 2012

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

3. Letter to the Medical Device Industry: Enhancements to the Medical Device Regulatory Framework

 

 

For further information, please contact:

 

Benjamin Gaw, Director, Drew & Napier 

[email protected]

 

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