A regulatory requirement for the sale of most types of medical devices in most markets is that the manufacturer has a quality management system (QMS).
For manufacturers marketing in Europe and Australia their QMS must meet the requirements of the international standard ISO13485 Medical Devices Quality Management System. Evaluation to this standard is a critical aspect of conformity assessment.
For manufacturers marketing in the US their QMS must meet the requirements of the US Quality System Regulations (QSR) as mandated in the US code of federal regulations.
The design of some types of medical devices require adherence to design control. Both ISO13485 and the QSR have sections relating specifically to design control.
Risk analysis is a key element of both ISO 13485 and the QSR.
MTC can provide advice on the type of QMS applicable to your type of product, and help with implementation and training specific to your needs.
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances.
Design controls begin with an analysis of the customer’s requirements, and ends with the successful and proven translation of these requirements into the final product.
Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.
Design controls are incorporated into the manufacturer’s quality management system and are mandatory for most devices marketed in the US, and for most high-risk devices marketed in Australia and Europe.
Risk analysis is also a key element of design control.
MTC can help in establishing design control procedures in your company, and help with implementation and training.
Risk Analysis Manufacturers of all types of medical devices must have appropriate risk analysis procedures. Risk analysis is the procedure through which medical device manufacturers identify and manage the hazards and risks associated with their products. It is applicable to all stages of the lifecycle of a medical device, and includes the following elements:
Identification of hazards
Estimation of occurrence and severity of hazards
Determination of acceptable risk levels
Identification and implementation of risk control measures
Evaluation of risk control effectiveness
ISO 14971 Medical Devices - Application of Risk Management to Medical Devices is the international standard recognised by most regulatory bodies, including the TGA, FDA and European regulators.
MTC can help in establishing risk analysis procedures in your company, and help with implementation, facilitation and training.
Design Dossiers As part of the regulatory conformity assessment process for Class III and Active Implantable Medical Devices sold in Australia and Europe, the product’s design must be examined by the TGA or other appropriate regulatory body. This requires compilation of a design dossier.
The design dossier includes a description of the device and evidence of compliance to essential principles/requirements. It typically includes:
Design specifications and procedures
Verification and validation testing
Labelling and instructions for use
Once the design has been assessed and found to meet requirements, a design examination certificate is issued.
MTC can help in compiling design dossiers for your products.
A technical tile must be maintained by manufacturers of all medical devices sold in Australia or the US.
The technical file is a compilation of documents that demonstrate compliance to regulatory requirements. It typically includes:
Verification and validation testing
Labelling and instructions for use
Contract manufacture agreements
Post-market surveillance and vigilance procedures
MTC can help in compiling technical files for your products.
An important consideration in the design of any medical device is the choice of materials, particularly those that are contact with the body. Materials must be evaluated and tested to ensure they are safe for their intended use.
ISO10993 Biological Evaluation of Medical Devices includes a series of standards relevant to the evaluation of materials.
MTC can provide advice on materials selection, evaluation and testing.
A key element of clinical evidence for some devices, especially those with new or unproven technology, is clinical trial data.
Regulations for the conduct of clinical trials exist in most countries. These usually require nomination of the principle investigator and the institutions where the trial will be conducted, a protocol reviewed and approved by an institutional ethics committee or review board, and procedures to protect the rights of the patient. In most cases, approval from, or notification to, national regulatory bodies is also required prior to the start of human trials.
Clinical trial activities extend from site evaluation, initiation, monitoring, audit and site closure through to associated clinical documentation.
The design and conduct of clinical trials are performed in accordance to ISO 14555 Clinical investigation of medical devices for human subjects and Good Clinical Practice (GCP).
Product marketing plays an important role in the product development cross-functional team. Product marketing is the function that analyses and articulates the needs of the customer, and provides critical input to the design. The collation of customer requirements is the first step of the design control process.
Acknowledging the importance of product marketing function at the start of the development process helps ensure your product is designed for customers, not for engineers!
The product marketing function also manages marketing communication, product positioning, and launch strategies.
MTC can help ensure the product marketing functions within product development are addressed.
A manufacturer uses a conformity assessment procedure to demonstrate that a medical device conforms to the essential principles of safety and performance defined in the Australian and European legislation. Depending on the procedure chosen, the final design and manufacturing controls may need to be assessed by the TGA or another appropriate conformity assessment body prior to the device being included on the ARTG or CE Marked.
Medical devices sold in Australia that require conformity assessment by the TGA include:
Medical devices manufactured in Australia (except Class I devices that are not provided sterile and do not have a measuring function)
Medical devices containing material of human, animal, microbial or recombinant origin.
Medical devices containing a medicine
For other devices, TGA will accept conformity assessment certificates (e.g. CE Certificates) issued by European Notified Bodies.
For Class III and Active Implantable Medical Devices, conformity assessment includes an assessment of the product’s Design Dossier.
MTC can help you through the Conformity Assessment process.
Once a product as been approved for supply, the obligations of manufacturers and sponsors does not stop. The device must continue to meet regulatory, safety and performance requirements that were required for the approval.
This requires manufacturers and sponsors to have procedures in place to proactively monitor the performance of the device, and to implement corrective action in the case of adverse events. In some situations, notification to regulatory bodies and/or the recall of product may be required.
Distributors (sponsors) of AIMD, Class III or implantable Class IIb devices must provide three consecutive annual reports to the TGA once the products are included on the ARTG. Reports must include all complaints received by the manufacture relating to problems with the use of the device.
MTC can help in establishing post-market surveillance and vigilance procedures in your company, and help with implementation and training.
Depending on the type of product, in some countries the cost of medical devices is reimbursed by public or private health insurance.
For example, in Australia private health insurance companies may reimburse the policy holder (i.e. patient) the cost of an implanted prosthetic device. To be eligible for reimbursement the product must first be included on the Prosthesis Benefits List.
For some medical devices, the market success of the product in Australia may be reliant on a Government Medicare code. Applications for new Medicare codes are evaluated by the Medical Services Advisory Committee.
The Medicines (Database of Medical Devices) Regulations 2003 require the Director General of Health, New Zealand to maintain a database of all medical devices supplied in New Zealand.
A Sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices) is required to enter details into the database (known as "WAND") within 30 days of commencing supply or export of a new medical device.
MTC can assist in placing your products on the WAND database.
Depending upon their composition and intended purpose, the supply of cosmetics in Australia may be regulated as an “industrial chemical”, as a medical device, or as a medicine.
A cosmetic product classed as a medical device or a medicine must first be registered with the TGA, i.e. “included” on the Australian Register of Therapeutic Goods (ARTG) before it can be marketed in Australia. Refer TGA Product Registrations.
Cosmetics fall under the regulatory control of the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).
MTC can provide advice on classification of cosmetic products. MTC can also help with inclusion of products on the ARTG, or registration with NICNAS.
In most markets the advertising and promotion of medical devices is regulated.
In Australia, the Therapeutic Goods Advertising Code applies to advertisements for therapeutic goods that are directed to consumers. It is administered by the Therapeutic Goods Advertising Code Council (TGACG).
The TGA also has regulations dealing with advertising of therapeutic goods.
MTC can help if you believe competitors may be in violation of the Therapeutic Goods Advertising Code, or if the TGACG has contacted you about your advertising practices.
Medical devices sold within the European market must have the CE Mark affixed. The CE Mark indicates that the product is in compliance with regulatory mandates.
There are several routes available to obtain CE Marking. In most cases, manufacturers will need to have conformity to regulatory requirements assessed by a Notified Body. The TGA is a recognised Conformity Assessment Body able to award the CE Mark.
Class I products that are non-sterile and do not have a measuring function can be CE Marked without the intervention of a Notified Body. However, there are still certain regulatory requirements and obligations that must be fulfilled before the CE Mark can be affixed.
MTC can advise on the best route to follow for CE marking your product, and help you with the overall CE marking process.
The US represents the biggest market for most medical device manufacturers, and its medical devices regulations are quite different from other major markets. Understanding a product’s US regulatory strategy is thus critical for the success of the product. Depending upon the type of device and its classification, regulatory clearance/approval process may take as little as 3 months, to as long as 5 years.
Contact MTC for advice on regulatory strategy for the US market.
Most markets have made progress towards medical devices regulation harmonization. This means that satisfying the regulatory requirements for one market will satisfy the requirements for other markets. However, as always, there are still individual peculiarities to all markets.
MTC can help you to navigate the complexities of regulatory approvals for all international markets.