Health Sciences Authority issued a press release announcing changes to the regulatory process for medical devices. The changes include:
>> Faster market access for lower risk MDs;
>> Clearer regulatory controls for newer MDs (e.g. telehealth devices) and higher risk MDs; and
>> Greater emphasis on post-market measures.
The changes, effective 1 June 2018, are a result of extensive consultation with the medical industry, where Qualtech had covered the outcome of the public consultations in earlier regulatory update articles.
1) Licensing of Manufacturers, Importers and Wholesalers of Medical Devices
Changes made by HSA includes exemption on certain manufacturing activities that involves customizing products and repair of certain devices for end users. Details is summarized in the following table:
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The following medical device manufacturing activities do not require a manufacturer’s license: |
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a. Manufacture by way of fitting or adjusting the medical device to meet the requirements of the end user - Fitting of hearing aids using fitting software - Taking dental impression for making dentures or crowns from resins - Adjustment of spectacles by hand/ using special tools for better fit - Adaptation and fitting of the orthopaedic implants to the patient’s anatomy |
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b. Manufacture to enable the continued use of the medical device by the end user - Fix and refit broken frame or refitting lenses or replacing screws - Fix and refit of prosthetics |
Requirements for exemption from obtaining secondary assembly licensing were also added to the revised guidance:
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Requirements for exemption from Secondary Assembly licensing: a. Company holds an importer’s licence or a wholesaler’s licence b. Company complies with the requirements of the Good Distribution Practice Standard for Medical Devices (GDPMDS) including the clauses related to secondary assembly or ISO 13485 |
Each licensing application will be screened prior to reviewing. Any applicant compliance that is needed during this screening will be through an input request. The compliance must be met by the applicant during the prescribed time. After successful screening, the application will be reviewed as per the timeline set by the following table:
Table 1. TAT and Fees for License registration and amendment
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Application type |
Turn around time (working days) |
Fees |
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New medical device dealer’s licences (including manufacturer’s, importer’s and wholesaler’s licences) |
10 |
$ 1000 per license |
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Amendment of dealer license |
10 |
$150 per application |
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Submission of Class A medical device exemption list |
N/A |
N/A |
HSA updated the supporting documents needed to obtain license. In addition, HSA requires all dealers (except for Class A device dealers, importation for re-export only and importation for non-clinical use only) to have GDPMDS certification. The said certification should be performed by accredited third party bodies which is listed in an accreditation site.
Table 2. Supporting documents to obtain license
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Manufacturer’s Licence |
Importer’s Licence |
Wholesaler’s Licence |
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Type of QMS certification |
ISO 134851 or Declaration of conformity to a QMS |
ISO 134851 or GDPMDS or Declaration of exemption from GDPMDS or Declaration of conformity to a QMS |
ISO 134851 or GPDMDS3 or Declaration of exemption from GDPMDS or Declaration of conformity to a QMS |
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Other document where applicable |
Declaration letter of non-dealing in Class A medical devices |
Declaration letter of non-dealing in Class A medical devices |
Nil |
HSA made some additional notes for some items that are applicable for license amendment:
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Change of risk classification of medical devices: Can be done via license amendment application at no charge |
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Change of QMS (Quality Management System) certification type: supporting documents should include new QMS certificate or declaration letter from licensee |
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Changes to Class A devices: If a company decides to deal with Class A devices, updates on the list of Class A medical device will be required. |
2) Risk Classification of General Medical Devices
HSA has updated the Risk Classification guidance for general medical devices.There are new definitions for Accessory, Active Implantable Medical Device, and Active Medical Device:
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Accessory: for the purposes of this guidance document, means an article that is intended specifically by its product owner to be used together with a particular medical device to enable or assist that device to be used in accordance with its intended purpose. An accessory is typically intended to be used for one or more of the purposes as described in the definition of medical device and therefore should be considered a medical device. |
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Active Implantable Medical Device: means any active medical device that is intended by its product owner to be introduced, either by surgical or medical intervention, wholly or partially into the body of a human being; or by medical intervention, into a body orifice; and, to remain in place after the procedure. |
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Active Medical Device: means any medical device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy, but does not include any medical device intended to transmit energy, substances or other element between that medical device and a patient without any significant change to that energy, substance or element. |
As mentioned in the definition, if an accessory intends to aid to the use of the device, then the accessory will be classified as a medical device. In the new regulations, these accessories will be subjected to regulatory control by HSA.
Part of the amendment in the regulations are minor revision on the rules of classification:
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Old Regulation |
New Regulation |
Changes |
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Rule 1: All non-invasive devices which come into contact with injured skin: |
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- are in Class A if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates only, i.e. they heal by primary intent; |
- are in Class A if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates only, for wounds that heal by primary intention. |
Included wounds that heal by primary intention |
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are in Class B if they are intended to be used principally with wounds which have breached the dermis, including devices principally intended to manage the microenvironment of a wound. |
- are in Class B if they are intended to be used to manage the microenvironment of the wound. |
Focused on the devices intended to be used in managing the microenvironment of the wound. |
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Unless they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent, in which case they are in Class C. |
Unless they are intended to be used principally with wounds that cannot heal by primary intent, in which case they are in Class C.
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Rephrased to devices that can’t heal by primary intent |
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Rule 2. All non-invasive devices intended for channelling or storing body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class A, |
Rule 2(i). All non-invasive devices intended for channelling tissues, channelling or storing body liquids, liquids or gases
for the purpose of eventual infusion, administration or introduction into a human body are in Class A, |
From Rule 2 to Rule 2(i) |
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Unless they are intended for use of channeling blood, or storing or channeling other body liquids, or for storing organs, parts of organs or body tissues, in which case they are Class B. |
Rule 2(ii). All non-invasive devices intended for they are intended for channeling blood or blood components, or storing organs, parts of organs or body tissues, for the purpose of eventual infusion, administration or introduction into a human body are in Class B, |
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Rule 3. Unless the treatment consists of filtration, centrifuging or exchanges of gas or of heat, in which case they are in Class B. |
Rule 3 Unless the intended modification is carried out by filtration, centrifuging or exchanges of gas or of heat, in which case they are in Class B.
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Term change from “treatment” to “intended modification” |
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Rule 4. All other non-invasive devices are in Class A. |
Rule 4. All other non-invasive devices that do not come into contact with the patient or contact intact skin only are in Class A. |
Expounded the applicability of non-invasive devices |
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Rule 5 - are in Class A if they are intended for transient use;
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Rule 5 - are in Class A if they are intended for transient use;
Unless they are intended for transient use on the external surface of the eyeball, and are liable to be absorbed by the mucous membrane, in which case they are in Class B,
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Extended the rules for transient use applicability in Rule 5 |
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Rule 5 -are in Class B if they are intended for short-term use;
Unless they are intended for short-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class A, |
Rule 5 -are in Class B if they are intended for short-term use;
Unless they are intended for short-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity, and are not liable to be absorbed by the mucous membrane in which case they are in Class A,
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Added “not liable to be absorbed by the mucous membrane” |
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Rule 6.
Unless intended to have a biological effect or be wholly or mainly absorbed, in which case they are in Class C; or |
Rule 6.
Unless intended to have a biological effect or to be wholly or mainly absorbed by the human body, in which case they are in Class C; or
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clarified the aspect of the device to be wholly or absorbed by the human body |
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Rule 9(i). All active therapeutic devices intended to administer or exchange energy are in Class B, |
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Pointed the human body as the recipient or the vessel in which the device will exchange energy with |
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Rule 9(ii). All active devices intended to control or monitor the performance of active therapeutic devices in Class C, or intended directly to influence the performance of such devices, are in Class C. |
Rule 9(ii). All active devices intended to control or monitor the performance of active therapeutic devices in Class C or higher, or intended directly to influence the performance of such devices, are in Class C. |
Added “Class C devices or higher” |
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Rule 11.
Unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration, in which case they are in Class C. |
Rule 11.
Unless this is done in a manner that is potentially hazardous, taking into account the nature of the substances involved, the part of the body concerned and the mode and route of administration or removal, in which case they are in Class C.
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Added “removal” |
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Rule 13.
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, and which is liable to act on the human body with action ancillary to that of the devices, are in Class D. |
Rule 13.
All devices incorporating, as an integral part, a substance which, if used separately, is a registrable therapeutic/medicinal product, and which is liable to act on the human body with action ancillary to that of the devices, are in Class D.
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Change from “a medicinal product” to “registrable therapeutic/medicinal product” |
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Rule 14. All devices manufactured from or incorporating animal or human cells, tissues and/or derivatives thereof, rendered nonviable, or cells, tissues and/or derivatives of microbial or recombinant origin are Class D, |
Rule 14. All devices manufactured from or incorporating cells, tissues or derivatives of cells or tissues of animal origin, rendered non-viable, or derivatives of cells or tissues of human origin, rendered non-viable, or cells, tissues or derivatives of cells or tissues of recombinant origin
are Class D, |
Separate item for “human and animal cell” |
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Rule 15
Unless they are intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses, in which case they are in Class C. |
Rule 15
Unless they are intended specifically to be used for disinfecting or hydrating contact lenses, in which case they are in Class C.
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Removed “cleaning, rinsing or, when appropriate” |
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3) Medical Device Product Registration
HSA added definition for telehealth and it categories:
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TELEHEALTH: The provision of healthcare services over physically separate environments via infocomm technologies, categorised into four broad domains: > Tele-collaboration; > Tele-treatment; > Tele-monitoring; > Tele-support. |
Class A devices in the new regulation are exempted from product registration but these will need to comply with the Essential Principles for Safety and Performance for Medical Devices as specified in the Regulations prior to their placement on the Singapore market. If a Class A device is used with a registrable device in a closed system, the registrable device must be first registered before listing in SMDR. If there will be changes in the listing information of the listed Class A device/s, then Change Notification is needed.
All devices in submitted in different grouping (single, group, family or system) application must be eligible for the selected evaluation route. HSA introduced a new evaluation route for registration of Class B and C devices:
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Immediate Class B Registration (IBR) Evaluation Route o Eligibility: § Condition 1 · At least one approval from HSA’s independent reference regulatory agencies · Marketed for at least three years in the above independent reference regulatory agency’s jurisdiction · No safety issues globally · No prior rejection/withdrawal of the medical device by/from any reference regulatory agency § Condition 2 · At least two approval from HSA’s independent reference regulatory agencies · No safety issues globally · No prior rejection/withdrawal of the medical device by/from any reference regulatory agency |
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Immediate Class B Registration (IBR) Evaluation Route (standalone medical mobile application)
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Immediate Class C Registration (IBR) Evaluation Route (standalone medical mobile application)
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HSA aims to help applicants to gain faster access to Singapore market. The newly devised Priority scheme can help different manufacturers with this aim. This scheme is for those applicants that will go through Full Evaluation route. Priority Scheme has two routes:
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Eligibility for Route 1:
*no existing alternative treatment or means of diagnosis or represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology |
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Eligibility for Route 2:
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With the modification in the evaluation routes and introduction of Priority Scheme, the following will be the turn- around time and fee for the modified evaluation route:
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Risk Class |
Turn Around Time for Registration Routes (working days) |
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Immediate |
Expedited |
Abdriged |
Full |
Full(Priority Scheme) |
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Class B |
Immediate Registration upon Submission |
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100 |
160 |
120 |
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Class C |
Immediate Registration upon Submission( for standalone medical mobile application only) |
120 |
160 |
220 |
165 |
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Class D |
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180 |
220 |
310 |
235 |
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Class D (devices that incorporates medical products) |
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220 |
310 |
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4) Dealers on Class A Medical Devices
Class A devices, both sterile and non-sterile, will not be required to be registered anymore. Instead, they should be listed in a Class A medical device register by HSA licensed dealers. The dealers should make sure that the device will still conform to Essential Principles for Safety and Performance for Medical Devices. HSA provided a non-exhaustive list of devices which can be considered as Class A.
5) Labelling for Medical Devices
HSA released a new guidance document on labelling which gives flexibility for the manufacturer where to put the pertinent information in the device or its packaging. In addition of providing the general contents of labels, the new guidance also provides important information that should be present for the following:
- Sterile devices
- Non-sterile devices
- Single-use devices
- Reusable devices
- Custom-made devices
- Medical device intended for clinical investigation or performance evaluation
- Devices to be supplied for non-clinical use
- Refurbished medical devices
- Medical device incorporating or administering medicinal or biological substance
From the changes in licensing to improvement of evaluation routes, the change in regulation by HSA entices more manufacturers and product owners to enter the Singapore market in the future from low to high risk devices. Hopefully, the new regulations will make registration process efficient so Singapore can be a venue of a healthy medical device market.
References:
- GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices. (2018). 4th ed. [ebook] Singapore: Health Science Authority.
- GN-13: Guidance on the Risk Classification of General Medical Devices. (2018). 2nd ed. [ebook] Singapore: Health Science Authority.
- GN-15: Guidance on Medical Device Product Registration. (2018). 7th ed. [ebook] Singapore: Health Science Authority.
- GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration.
- GN-23: Guidance on Labelling for Medical Devices. (2018). 4th ed. [ebook] Singapore: Health Science Authority.