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Medical Device Registration Details needed:  

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Medical Device Registration Details needed:  

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Device description

Information of design verification and validation documents such as full reports of preclinical studies

Clinical evaluation report, including publications and full reports of studies references

Risk analysis

Name and address of the manufacturing and sterilization sites

Manufacturing process

Proof of at least one of the quality management systems

Manufacturer’s licence

CRIS company account for MEDICS

CorpPass or HSA pin

Application fees required

Payment mode: GIRO and eNETS

Must be approved by any of our independent reference regulatory agencies

The rules for classification of different risk level can be found in the link below.

LINK: https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule#tab=tab-general-medical-devices&toggle=togglepanel-rule-5-non-surgically-invasive-devices-i-e-devices-which-are-invasive-through-body-orifices-only

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Full Evaluation Route (qualifications as defined above)

Abridged Evaluation Route (qualifications as defined above)

Expedited Evaluation Route

Expedited Class C Registration (ECR) – same qualifications as for EBR

Expedited Class D Registration (EDR) – To qualify for EDR, the device must have obtained approvals from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to that intended for marketing in Singapore. The following devices do not qualify for EDR: active implantable devices; implantable devices in direct contact with the central nervous system; hip, knee and shoulder joint replacements; devices incorporating a registrable drug in an ancillary role, IVD devices intended for HIV testing or blood/tissue donor compatibility testing.

Process for Evaluation Routes (1-3) Above

Submission of application via MEDICS

Verification of Application

Evaluation of Application

Regulatory decision and listing on SMDR for successful registration

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Risk level: high risk

Example: heart valves and implantable devices

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(4) Immediate Class B Registration (IBR) Evaluation Route

To qualify for the IBR evaluation route, at the time of the submission the medical device must fit the following criteria:

1. Have approval from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to the one intended for marketing in Singapore.

2. Marketed for at least three years in two of the above independent reference regulatory agencies’ jurisdiction.

3. No safety issues globally associated with the use of the medical device when used as intended by the Product Owner in the last three years.

4. No rejection/withdrawal of the medical device by/from any reference regulatory agency/that foreign jurisdiction(s) or HSA/Singapore due to quality, performance/efficacy or safety issues.

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Process for Evaluation Routes (1-3) Above:

1. Submission of application via MEDICS

2. Verification of Application

3. Evaluation of Application

4. Regulatory decision and listing on SMDR for successful registration

Process for the IBR Evaluation Route

1. Successful submission of application via MEDICS

2. Device is registered and listed on SMDR

3. Verification of Documents

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Risk level: moderate to high risk

Example: ventilators

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(3) Expedited Class B Registration (EBR) Evaluation Route

To qualify for EBR1, at the time of the submission the medical device must fit the following criteria:

1. Have approval from at least one of HSA’s independent reference regulatory agencies for a labeled use identical to the one intended for marketing in Singapore.

2. Marketed for at least three years in the above independent reference regulatory agency’s jurisdiction.

3. No safety issues globally associated with the use of the medical device when used as intended by the Product Owner in the last three years.

To qualify for EBR2, at the time of submission the medical device must have obtained approvals from at least two of HSA’s independent reference regulatory agencies for a labeled use identical to that intended for marketing in Singapore.

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(2) Abridged Evaluation Route – To qualify, a medical device must have obtained at least one regulatory agency approval for a labeled use identical to the one intended for marketing in Singapore at the time of submission.

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(1) Full Evaluation Route – A medical device that has not obtained any prior approval from any of HSA’s reference regulatory agencies at the pint of application will be subject to the full evaluation route. 

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(1) Full Evaluation Route – A medical device that has not obtained any prior approval from any of HSA’s reference regulatory agencies at the pint of application will be subject to the full evaluation route. 

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Risk level: low to moderate risk

Examples: hypodermic needles

To register for class B to D medical devices, using the internet explorer, open the website.

https://www.hsa.gov.sg/e-services/medics

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Class A medical devices are exempted from product registration but will require to complete the class A exemption list in MEDICS during Dealer’s licence application.

Risk level: low risk

Examples: bandages

Use the internet explorer and open this website to register a class A medical device

https://eservice.hsa.gov.sg/medics/md/mdEnquiry.do?action=loadClassA&_ga=2.192597034.1803903920.1554265549-551332391.1551944793

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Approval: The application satisfies the registration requirements for quality, safety and efficacy

Approvable: Indicates the application can be approved, subject to adequate responses to minor deficiencies.

Non approvable: non-approvable application has major deficiencies that need to be addressed.

Rejection: response failed to address the major deficiencies specified in the non-approvable decision.

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Stage 1: Acceptance for evaluation
-  Application is accepted for evaluation. This marks the start of the evaluation timeline.

Stage 2: Active evaluation in progress
- When active evaluation is in progress for the application.

Stage 3: Evaluation at midway
- Application is approximately midway through the evaluation. Applicants can expect to receive the first set of queries from us during this stage.

Stage 4: Completed evaluation
- Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision will be issued

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To ensure the application type is correct and that the dossier is complete.
The screening timeline starts from the date of receipt of the application dossier.

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Full: Any new product that has not been approved by any drug regulatory agency.This evaluation route only applies to new drug applications (NDA).

Abridged: Any new or generic product that has been approved by at least one drug regulatory agency. This evaluation route applies to both new drug applications (NDA) and generic drug applications (GDA).

Verification: Any new or generic product that has been approved by our reference drug regulatory agencies. This evaluation route applies to both NDA and GDA.

Verification-CECA: Any generic product manufactured in India which has been approved by our reference drug regulatory agencies. This evaluation route only applies to GDA of products manufactured in India.

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- Should be submitted within 2 working days of the PRISM application submission for the NDA or GDA.
- Application dossier must be organised in either the International Council for Harmonisation Common Technical Document (ICH CTD) or the ASEAN CTD format

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GDA-1:First strength of a generic chemical product

GDA-2: For subsequent strengths of the generic chemical product that has been registered or submitted as GDA-1. The product name and dosage form should be the same as that for the GDA-1.

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NDA-1: 1st strength of product containing new chemical/biological entity

NDA-2:1st strength of product but contains new combination of registered chemical/biological entity

New dosage form,

New presentation, such as single-dose vials, multi-dose vials and pre-filled syringes.

New formulation, such as preservative-free.

Registered chemical or biological entities for use by a new route of administration.

Registered chemical or biological entities for new indication, dosage recommendation or patient population.

NDA-3:For subsequent strengths of a product that has been registered or has been submitted as a NDA-1 or NDA-2.

The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2 submission.

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Applications submitted through PRISM:
-Must have CRIS company account and CorpPass/HSA pin

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The acknowledgement of product notification from HSA must be

received by the person responsible before the product can be supplied.

Subsequent re-notification is required every year if the cosmetic product

continues to be supplied in the market.

Notification need not be submitted if:

a cosmetic product that is supplied solely as a sample in

connection with any advertising, sponsorship or promotional

activity; or

a cosmetic product that is supplied solely for testing or trial use in

connection with any research or development of that product; or

a cosmetic product that is manufactured by or in accordance with

the specifications of a medical practitioner, and supplied solely by

that medical practitioner for the use of patients under his care.

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4) Pay Annual feels for both notification and re-notification

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4) Pay Annual feels for both notification and re-notification

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Payment by Giro or eNET

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3) Determine High/Low risks cosmetic product

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3) Determine High/Low risks cosmetic product

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High risks: Applied around eyes, lips, hair dye containing phenylenediamines and oral and dental care

Low risks: All other cosmetics products that are not listed above such as moisturiser and skin whitening

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a) To apply for a cosmetic product notification, please use Internet Explorer 8.0 and above and go to the following website: https://www.hsa.gov.sg/e-services/prism/cosmetic-products-oral-dental-gums

b) Click on “Apply for cosmetic product notification” Step-by-Step Guide on Product Notification Dec 2019

c) Thereafter, you will be directed to the following page: Login using CorpPass or HSA PIN

d) Upon successful authentication, a welcome page will be shown. Click “Accept/Continue” to proceed with the eService. You will be directed to the online application form. The application form consists of 6 sections:

1. Particulars of local company responsible for placing the cosmetic product in the market

2. Particulars of person authorised to represent the local company

3. Particulars of manufacturer(s)

4. Particulars of product

5. Supporting document(s)

6.Declaration, validation, confirmation, & payment

* It is recommended for users to fill in the application form details in a systematic manner

* PLEASE FILL IN ALL SECTIONS IN ENGLISH To note: A HSA Pin holder or a drafter is able to fill up the form only. He or she is not authorised to submit the notification.  A submitter can perform both form filling and notification submission  CRIS Administrator can draft and submit a cosmetic product notification Step-by-Step Guide on Product Notification Dec 2019

e) Section 1: Particulars of local company responsible for placing the cosmetic product in the market a. Ensure that the details are accurate and corresponds to your company details. Fill in the Billing Address if the answer is “No” to section 1.6 b. Click “Next” to proceed to the next section

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Client Registration and Identification Service (CRIS)

CorpPass

is a corporate digital identity for businesses and other entities (such as non-profit organisations and associations) to transact with Government agencies online. Managed by Government Technology Agency (GovTech), CorpPass is the single login method for G2B transactions from 1 September 2018