Singapore

Medical Devices

 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.  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.

 

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. Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA’s website.

Authorized local agent

GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics. GRP helps manufacturers, distributors, and marketers of cosmetics in Singapore. GRP can at as your Responsible Person in Singapore and ensure successful product registration and approval in Singapore.

GRP Cosmetic Services  in Singapore:

  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Manage Distributor
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

GRP experts can collect the HSA regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Singapore’s Market.

Regulatory Strategy

Developing the right regulatory strategy for your products in Singapore is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets in Singapore. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment.

With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with the Health Science Authority (HSA) regulatory authorities. Our Regulatory affairs teams help cosmetic companies understand and efficiently manage the demanding complexity of the HSA Regulatory requirements in order to successfully register and commercialize their products in Singapore’s market.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate HSA regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with HSA requirements and the products can be used safely by the consumers. GRP can review your cosmetic packaging and labels to make sure it complies with Cosmetic Regulation standards.

Product classification & Formulation Review

Global Regulatory Partners Inc. (GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP can review your cosmetic classification and ingredient formulation to make sure it complies with HSA standards.

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. 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. Click here.

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.

Global regulatory partners, Inc. (GRP) can act as your local agent and provide you with the following pharmaceutical services:

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

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 with minimal risk.

GRP medical device/ IVD regulatory 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 Content

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.

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 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. 

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.

Cosmetics

In Singapore, cosmetics are regulated by Health Sciences Authority (HAS) that is operating under the Ministry of Health. In addition to HSA regulations, companies must comply with Health Products (Cosmetic Products- ASEAN Cosmetics Directive) Regulations as well. Cosmetics are defined as any substance or preparation that is intended to be placed in contact with the external parts of the human body e.g. skin, hair, nails, lips, or mouth including gums, teeth, tongue, for the purpose of cleaning them, perfuming them, changing their appearance, correcting body odors or protecting them or keeping them in good condition.” Singapore is one of the world’s most affluent markets in Asia and is considered a Showcase-Market for the introduction of Cosmetics to the rest of Southeast Asia.

Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in Singapore. GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in Singapore and find the appropriate local distributor for your product.

 Related links:

Use the classification guide to check if your product is a cosmetic in Singapore. Click here.

Authorized local agent

GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics. GRP helps manufacturers, distributors, and marketers of cosmetics in Singapore. GRP can at as your Responsible Person in Singapore and ensure successful product registration and approval in Singapore.

GRP Cosmetic Services  in Singapore:

  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Manage Distributor
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

GRP experts can collect the HSA regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Singapore’s Market.

Regulatory Strategy

Developing the right regulatory strategy for your products in Singapore is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets in Singapore. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment.

With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with the Health Science Authority (HSA) regulatory authorities. Our Regulatory affairs teams help cosmetic companies understand and efficiently manage the demanding complexity of the HSA Regulatory requirements in order to successfully register and commercialize their products in Singapore’s market.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate HSA regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with HSA requirements and the products can be used safely by the consumers. GRP can review your cosmetic packaging and labels to make sure it complies with Cosmetic Regulation standards.

Product classification & Formulation Review

Global Regulatory Partners Inc. (GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP can review your cosmetic classification and ingredient formulation to make sure it complies with HSA standards.

Nutraceuticals

In Singapore, Nutraceuticals are known as “Health Supplements” and they are regulated by the Health Sciences Authority (HSA). They are defined as products used to supplement a diet, with benefits beyond those of normal nutrients, and / or to support or maintain the healthy functions of the human body. 

 

According to Singapore health legislation, health supplements include three categories: Vitamins and Dietary Supplements, Functional Foods and Functional Beverages. The products may include but not limited to: Vitamins, minerals, amino acids (natural and synthetic), substances derived from natural sources, like non-human animal and botanical materials in the forms of extracts, isolates, concentrates. Currently, health supplements can be imported and sold without a license from this Authority. They are not subjected to pre-market approval by this Authority. Nevertheless, manufacturers and distributors of health supplements are advised to comply with the guidelines for health supplements set out by this Authority.

 

Global Regulatory Partners, Inc. (GRP), has a team of experts in Singapore who can help Nutraceutical and food supplements companies in Singapore during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

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