Health Science Authority singapore

Medical Devices

Singapore’s Health Authority:

 In Singapore, medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). In 2007, the HSA passed the Health Products Act, allowing them to conduct mandatory product registration and regulate the supply, distribution, manufacturing, import, and advertisement of all health products.

Medical Device Definition:

 They are defined as health products which have a physical or mechanical effect when used on human bodies and are used to: Diagnose, alleviate or treat a medical condition, e.g. X-ray machines; Measure or monitor functions of the body e.g. glucometer; Products which are used to maintain or support general well-being, such as body toning equipment, magnetic accessories and massagers, are NOT medical devices and hence not regulated by HSA.

Medical Device Registration Process:

All medical devices and pharmaceutical products imported and/or sold in Singapore must be registered, regardless of risk class (except those exempted from registration). The licensing of dealers (manufacturers, importers, and wholesalers) is also mandatory.

More Resources:

  • For more information on the Medical Devices and our Services in Singapore please click the “Read More” Tab.
  • Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website

 

Health Science Authority (HSA) Organizational Chart 

Authorized local agent

Foreign medical device companies that don’t have local presence in Singapore must appoint a local agent to submit their device application and represent them to the Health Science Authority (HSA). The local agent must be a Singapore-based company, with local staff, and registered with the ACRA (Accounting and Corporate Regulatory Authority) in order to register an account with the HSA. Applications to the HSA can only be made via MEDICS (Medical Device Information and Communication System) e-Services.

GRP Medical Device Services in Singapore:

  • Communication with the HSA
  • Assistance with HSA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support HSA consultation meetings
  • Product registration
  • Clinical Trial management
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest HSA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Singapore.

Regulatory Strategy

Defining the right regulatory strategy to be able to navigate through the regulatory system in Singapore is essential for successful product’s registration in Singapore. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in Singapore, in timely manner and reduced risk.

GRP Medical Device Services in Singapore:

  • Communication with the HSA
  • Assistance with HSA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support HSA consultation meetings
  • Product registration
  • Clinical Trial management
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Singapore in order to successfully register and commercialize their products in  Singapore’s market and maximize the value of their assets.

GRP’s Regulatory Affairs Services: 

  • regulatory intelligence
  • regulatory strategy
  • regulatory operations and publishing
  • product’s registration,
  • products’ life cycle management and maintenance

Product registration

In Singapore, medical devices are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). Singapore is a member of the Association of Southeast Asian Nations (ASEAN).

The registration pathway of medical devices depends of their classification. Medical devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for abridged evaluation routes. I n Singapore, medical devices’ classification is based on a four-tier system (Class A, B, C, and D). Table below  shows the device  designated class and some examples. 

Table 1: Medical Device Classification

Device Class Description
Class A Low risk
Class B Low-moderate Risk (Ex. Hypodermic needles, suction equipment)
Class C Moderate-high Risk (ex. lung ventilator, bone fixation plate)
Class D High risk (ex. Heart valves, implantable defibrillator)

Product Registration Process:

The HSA submission dossier, or technical file, is based on the ASEAN CSDT (Common Submission Dossier Format). Most part, documentation from an EU technical file can be used to satisfy many supporting documentation requirements. Declaration of Conformity to the Essential Principles is required. Once approved, products are listed in the Singapore Medical Device Register (SMDR) database.

Medical Device Application Pathways 

Class A MD

Class A Non-Sterile Devices

Class A non-sterile medical devices are exempt from registration and do not need to be registered with the HSA prior to being placed on the market. However, Class A non-sterile medical devices require a local agent in Singapore with appropriate wholesaler/importer licenses.

Even though Class A non-sterile devices do not require registration with the HSA, they still must conform to the Essential Principles for Safety and Performance for Medical Devices prior to going on the Singapore market.

Class A Sterile Devices

  • Step 1: Submission of application dossier via the Medical Device Information and Communication System (MEDICS) – The product application fee is immediately charged upon application submission.
  • Step 2: Review of application dossier – The review conducted by the HSA is based on the supporting data, which the applicant submitted. If clarification or additional information is required, the HSA will issue the applicant a request.
  • Step 3: Regulatory decision and listing on the SMDR for successful registration – Upon review of the application submitted, a regulatory decision is made by the HSA. Applications that satisfied the registration requirements are then registered and listed on the SMDR.

Class B MD

Class B Medical Devices

There are 4 evaluation routes for Class B Medical Devices:

  • Full Evaluation Route
  • Abridged Evaluation Route
  • Expedited Evaluation Route (ERB)
  • immediate Evaluation Route (IRB)

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.

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.

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:

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

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:

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

Class C & D MD

Class C & D Medical Devices:

There are 3 evaluation routes for Class C & D Medical Devices:

Full Evaluation Route

– Abridged Evaluation Route

– 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.

Table 2: Content of Medical Device Registration Dossier

Content of the Registration Dossier
Class A Sterile Devices • Letter of Authorization
• Proposed Device Labeling
• IFU, patient information leaflet and promotional material (including brochures and catalogues)
• A list of all materials of animal, human, microbial and/or recombinant origin used and manufacturing process if applicable
• Sources of all materials of animal, human, microbial and/or recombinant origin used and manufacturing process (if applicable)
• Information on sterilization method(s) and validation standard(s) used
• Proof of Quality Management System (QMS) – E.g. ISO 13485 certificate, conformity to US FDA Quality System Regulations, Japan MHLW Ordinance 169 or attestation stating adequate QMS
Class B, C & D Devices • The content of the registration dossier is listed below
• Letter of Authorization
• Annex 2 List of configurations
• Proof of reference agency’s approval(s)
• Proof of marketing history in reference agencies’ jurisdictions (e.g. invoice with date, proof of sale, or a declaration on marketing history
• Declaration of no safety issues globally
• Executive Summary
• Essential Principles checklist and declaration of conformity
• Device Description
• Design verification and validation documents
• Clinical Evidence
• Proposed Device Labelling
• Risk Analysis
• Manufacturer information
• Proof of Quality Management System (QMS) E.g. ISO 13485 Certificate, Conformity to US FDA quality system regulations, Japan MHLW Ordinance 169
• Manufacturing Process Flow chart.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Singapore. As Regulatory authorities, the HSA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

It is highly recommended to have a pre-consultation meeting with health authorities such as with the Health Science Authority (HSA) during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the HSA before starting key milestone of your product development.GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the HSA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Quality

ISO 13485:2016 is a quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements serves as the basis for QMS compliance worldwide.

 

Dealer’s license Requirements:

Only medical device dealers licensed by HSA can engage in the manufacture, import and/or wholesale of medical devices in Singapore.

Advantages of ISO 13485 certification:

If you manufacture or market medical devices you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:

  • It is the “de facto” standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
  • ISO 13485 certification requires effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
  • Increased efficiency, better product quality and improved customer service within your company.
  • Your commitment to quality will be evident to your consumers and partner

GRP ISO 13485 Services:

    • Customization of your ISO 13485 quality system to meet your specific needs,
    • Training on ISO 13485 requirements
    • Ensure that your QMS is implemented on time and on budget.
    • Provide qualified recommendations for third-party testing and certification firms that specialize in your category of devices.
China’s NMPA Random Inspections of COVID-19 Medical Devices Manufacturers

Pharmaceuticals

In Singapore, therapeutic products, known as western medicines, are required to be registered with the Health Sciences Authority (HSA) before they can be supplied in Singapore. The Health Products Act (HPA) regulates the manufacture, import, supply, presentation and advertisement of therapeutic products.

Therapeutic Product Definition:

Under the First Schedule of the Health Products Act, the definition of a therapeutic product is separated into its intended use, constituent active ingredients, its inherent effects, and lastly defines what it is not (i.e. medical device, whole blood).

A therapeutic product  is  intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof ; for investigating, modifying, or replacing any physiological process; for influencing, controlling or preventing conception; or for inducing anesthesia.

Related Links:

  • Guideline on Therapeutic Product Registration

For more information on the Registration process click the “Read More” Tab.

Authorized local agent

A drug company that does not have its own locally registered office in Singapore can appoint a locally registered company (either a distributor or an independent third party) to act as their local authorized agent and submit registration applications on their behalf. Only a locally registered company can apply for a drug product license via PRISM (Pharmaceutical Regulatory Information System) and act as the product license holder, who is responsible for the safety, quality and efficacy of the product placed on the market.

GRP Pharmaceutical Services in Singapore:

  • Communication with the HSA
  • Assistance with HSA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support HSA consultation meetings
  • Product registration
  • Clinical Trial management
  • Support importation process
  • Post-market vigilance
  • Manage Distributors
Health Science Authority singapore

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest HSA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Singapore.

Regulatory Strategy

Defining the right regulatory strategy to be able to navigate through the regulatory system in Singapore is essential for successful product’s registration in Singapore. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in Singapore, in timely manner and reduced risk.

GRP Pharmaceutical strategy services in Singapore:

  • Identify and the latest regulatory requirements related to your medical device.
  • Proactively identify challenges or issues that may delay the approval of your medical device in Singapore.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your medical product registered in Singapore.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Singapore include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Singapore in order to successfully register and commercialize their products in Singapore’s market and maximize the value of their assets.

Product registration

A company seeking to market a therapeutic product can make an application for registration via PRISM.

Application Types:

In applying for a new product registration for a therapeutic product in Singapore, there are two categories of applications – a new drug application (NDA) and a generic drug application (GDA).

A generic drug application applies to a therapeutic product that contains one or more chemical entities, and that is essentially the same as a current registered product with respect to its qualitative and quantitative composition of active ingredients, pharmaceutical dosage form and clinical indication.  

Table 1: Application Types and Description

Application Type Application Class Application Description
NDA – New Drug Application NDA-1 For the first strength of a product containing a new chemical or biological entity
NDA-2 (a) For the first strength of a product
1. containing a new combination of registered chemical or biological entities;
2. containing registered chemical or biological entity(ies) in a new dosage form (e.g. tablets, capsules, injectables), new presentation (e.g. single-dose vials, multi-dose vials, pre-filled syringe) or new formulation (e.g. preservative-free);
3. containing registered chemical or biological entity(ies) for use by a new route of administration; or, (iv) containing registered chemical or biological entity(ies) for new indication(s), dosage recommendation(s) and/or patient population(s).
(b) For products that do not fall under the requirements for NDA-1, NDA-3 or GDA.
NDA-3 For subsequent strength(s) of a product that has been registered or has been submitted as an 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.
GDA Generic Drug Application GDA-1 For the first strength of a generic chemical product.
GDA-2 For subsequent strength(s) 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.

Table 2: Evaluation Routes

Evaluation Routes
Full route Applies to any new product that has not been approved by any drug regulatory agency at the time of application submission to HSA.
Abridged route Applies to any new or generic product that has been evaluated and approved by at least one drug regulatory agency
Verification route Applies to any new or generic product that has been evaluated and approved by HSA’s reference drug regulatory agencies, which are EMA, US FDA, Health Canada, TGA and UK MHRA.

Application Process:

Step 1: Online application submission via PRISM

Step 2: Application Dossier (Should be submitted within 2 working days after application via PRISM)

Either the ICH CTD or the ACTD format is acceptable for making a submission to HSA.

Table 3: Submission Material

Documents Location in ICH CTD Location in ACTD
Administrative Documents and product information Module 1 Part I
CTD Overview and summaries Module 2 Incorporated in parts II, III and IV
Quality Documents Module 3 Part II
Non-clinical documents Module 4 Part III
Clinical Documents Module 5 Part IV

Post-Market Changes:

Any post-registration changes that occur during the product’s life cycle that may affect the product’s efficacy, quality and/or safety can only be made after approval for the variation has been obtained from HSA. There are two types of variation applications – major variation applications (MAV) and minor variation applications (MIV).

MAV-1: A variation to the indication(s), dosing regimen(s), patient population and/or inclusion of clinical information for extending the use of a registered product

MIV-1: A minor variation to the quality aspects, i.e chemistry, manufacturing and controls, and/or product labelling of a registered product.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Singapore and ASEAN.  GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Singapore. As Regulatory authorities, the HSA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health Authority Consultation

It is highly recommended to have a pre-consultation meeting with health authorities such as with the Health Science Authority (HSA) during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the HSA before starting key milestone of your product development.

GRP regulatory affairs Support team services:

  •  preparation and submission of the meeting package to the HSA health authority
  • prepare the questions based on the status of your product’s development and future
  • provide support during the meeting
  • write the meeting minutes and develop the appropriate action plan after the consultation meeting.
meeting | health authority

Clinical

An understanding of the regulatory requirements in Singapore and experience in dealing with the local regulatory authorities (HSA) is essential in administering a smooth, successful clinical trial in Singapore. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Singapore. Our local teams and affiliated partners located in Singapore and all-around Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

GRP clinical trials services for pharmaceutical companies in Singapore:

Clinical Trial Consulting Services

  • GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.

Regulatory Support

  • We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Singapore. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate HSA regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.

Clinical Trials Management

  • We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.

Quality Compliance and Audits

  • We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.

Adverse Events and Post Market Surveillance

  • We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Clinical trials that are conducted properly in Singapore will facilitate a smooth registration approval process and expedite access to other Asian markets. If you need assistance with clinical trials for your medical product in Singapore, contact us for a consultation with our regulatory experts.

Quality

Pharmaceutical Quality Systems for Drugs Products

Pharmaceutical companies are responsible for complying with HSA regulations to maintain a high level of safety, efficacy and quality of their products. Compliance can be achieved by implementing a pharmaceutical quality system. Adherence to the internal PQS can ensure the identity, strength, quality and purity of drug products by requiring stringent control of every step in the lifecycle. It is important to know CGMPs only are minimum (baseline) standards. A well-designed PQS should exceed these standards

Our Pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services include:

  • Full consulting GMP quality assurance and regulatory affairs.
  • Audits of your quality management system or a supplier’s quality system.
  • Review of corrective actions and recommendations for resolution.
  • Supporting quality metrics and analysis as part of the management review meetings.
  • Internal auditor training, risk management, quality system, or other training needs.
  • Complaint handling, contract review and surveillance audits.
  • Document control and maintenance of the quality system.