Singapore Medical Device Registration & Regulatory Consulting | GRP

Committed to your success, from Concept to Approval.

Singapore / MEDICAL DEVICES CONSULTING

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.

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.

To develop the right regulatory strategy, our Regulatory Team performs the following tasks:

  • 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.

MEDICAL DEVICE 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.

Medical Device Classification

In Singapore, medical devices’ classification is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest-risk products.

Products 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.

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

Products 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.

Applications Categories

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 Medical Devices

 There are 4 evaluation routes for Class B Medical Devices:

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 Medical Devices

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

  • 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.

Content of the Registration Dossier

Class A Sterile Devices

The content of the registration dossier is listed below:

  • 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.

Quality Compliance

Manufacturers of devices other than Class A non-sterile, must submit proof that their quality system complies with one of the following standards: ISO 13485, US FDA cGMP, or Japan MHLW Ordinance #169.

Local Representation

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 HSA. The local agent must be a Singapore-based company, with local staff, and registered with the HSA.

Clinical Trials

Clinical studies are not required for registration approval in Singapore.