General Procedure for New Product Registration for Medical Device Site

PURPOSE The purpose of this procedure is to document the processes involved and identify the supporting documentation required during the planning and submission of medical device registration applications to the Regulatory Bodies. The activities are the responsibility of the Regulatory Affairs / QA Department. SCOPE The procedure covers the following aspects:

• Obtaining the supporting documentation from the device Legal Manufacturer
• Registering the Manufacturer’s Evidence with the Regulatory Body
• Submitting the Device Application to the Regulatory Body
• Responding to an Application Audit
• Processing the registration approval documentation
• Communication of Registration Approval information within the company

INITIATING REGISTRATION Requests for registration must be received via e-mail from Sales and Marketing. When a request is received it is forwarded to the Site Coordinator for approval. If approval to register the product is granted, form “Registration Requirements Checklist” is completed and sent by RA/QA to the relevant Design Authority requesting the documents. COLLATING PRODUCT DOCUMENTATION A key part of submitting a product registration application is the availability of specific information relating to the product. This information must be supplied by the Legal Manufacturer and is collated and forwarded to the site initiating the registration. As a minimum the following information is to be available for each product or product type:

• Examples of product labelling
• Instructions for Use for the product
• Technical File for the product, indicating Intended Purpose, GMDN (Global Medical Device Nomenclature) code and Class of the device
• Notarised copies of the CE (Conformité Européene) certificate for the manufacturing site
• A Declaration of Conformance from the manufacture to regulatory requirements

ACCURACY OF DOCUMENTATION FROM LEGAL MANUFACTURER It is critical that the details supplied by the Legal Manufacturer are correct. The information must be carefully crosschecked by registrant site to ensure there are no anomalies. Submitting incorrect or insufficient information may result in the registration application being rejected by the Regulatory Body, which results in a loss of the application fee and significant delays in preparing a revised submission. Key details to check for accuracy are: Product Labelling

• Manufacturing Lot Number shown
• Product Code shown
• Expiry Date shown, if applicable
• Sterility status shown
• Notification of Single Use, if applicable
• Quantity per pack shown
• Registrant site identifier as the Sponsor for the device

Instructions for Use

• Must clearly indicate the Intended Purpose of the device
• Must clearly indicate the correct operation of the device
• Must clearly indicate any warnings or side effects of incorrect use of the device
• Must be written in English

Summary Technical File

• Contains a list of standards to which the product complies
• Details Inspection criteria
• Details the method of Sterilisation, if applicable
• Contains the Intended Purpose of Use
• Contains the GMDN code and Class for the device

Manufacturer’s CE Certificate

• The certificate must be notarised by an authorised individual
• The certificate dates must be current
• The certificate must be issued by an authorised Certification Body
• It must state the manufacturer has achieved compliance to the applicable Annex of the European Medical Device Directives (MDD)
• It must identify the product family of product codes for which it is applicable

Manufacturer’s Declaration of Conformance

• Must reference the appropriate regulatory act of the market to be registered
• Must identify the applicable Schedule and Part number of the regulations
• Must reference to applicable Annex of the European Medical Device Directives (MDD)
• Must identify the CE certificate number applicable
• Must show the GMDN code and Class of the device
• Must be an original signed document

Any anomalies found with the documentation must be reported back to the Legal Manufacturer for amendment. THE REGISTRATION SYSTEMS TO REGULATORY AGENCY In many OECD and North American countries have online portal to support electronic register of therapeutic goods. All aspects of new product registrations or amendments to existing registrations can be undertaken via these systems. Sometime fees are applicable to many registrations with hardcopy registration certificates showing the unique application reference number being issued to the sponsor. Sometime no fees are applicable to this system and no hard copy certificates are issued, only a unique notification number provided. MANUFACTURER’S EVIDENCE The Manufacturer’s Evidence is electronically stored into these online systems. Full details on how to access and register information on these systems are contained in the site specific user manuals which can be downloaded from the respective websites and to be kept within the RA/QA Department. The first stage in submitting a product registration application is to determine if the current Manufacturer’s Evidence lodged with the regulatory Body is suitable to support the device application. If the current Evidence has the appropriate GMDN code and Class of device already included, no further action is required. If these details need to be added in support of a new application or if a new Manufacturer’s Evidence needs to be generated, a New Evidence Submission or a Variation to Evidence will need to be created, as per the instructions in the applicable system User Manual. New or changed Manufacturer’s Evidence will be reviewed by the Regulatory Body and approved in due course. It must be noted that a Device Application cannot be generated until a Manufacturer’s Evidence has been accepted and approved by the regulatory Body. DEVICE APPLICATION Once the Manufacturer’s Evidence has been accepted, a Device Application can be submitted via the online systems. The Device Applications are made electronically and the full application process details are given in the applicable system user manuals. In some countries in conjunction with the electronic application, a hardcopy application must be submitted, which includes a cheque for the appropriate payment (where applicable), a covering letter, and a print out of the applicable application invoice screen. REGULATORY APPLICATION AUDIT In some cases the regulatory agencies can decide to perform an application audit, prior to accepting the Device Application. These application audits aim to confirm that the sponsor making the application actually has the manufacturer’s supporting documentation, detailed in points above. Sponsors make a legally binding declaration when submitting Device Applications via electronic system, reaffirming that all the relevant documentation is available for review if required. The regulatory agencies will formally contact the sponsor and ask for one copy of all the documentation to be supplied within a 20 day timeframe. Failure to conform can lead to legal action. Device Applications are not processed further, until the agency has completed the application audit and reviewed the documents supplied for accuracy. If the application audit is successful, the application will be accepted onto their system. If the application audit deems there to be inaccuracies with the information supplied, the application may be rejected. Once rejected the application would have to be re-submitted and the fees would be payable again. ACCEPTANCE OF APPLICATIONS If the regulatory agencies accept the application, this status is indicated in their systems sometime publicly available. The device application will have a unique page, which identifies all the details relating to the device or product range in question, identified by a unique reference number. The RA/QA Department prints out a copy of this page to file with the other documentation relating to the device application held in the job file. Upon notification of the acceptance of the application, the RA/QA performs the following:

• Add the product code and registration and/or notification number to the site product registration databases.
• Make copies of the registration certificate.
• Place registration page print outs with the application paperwork.
• Transfer all supporting documentation, print outs and certificates from the job folder into the registration files within the RA/QA Department.
• Provide Registration Department with a copy of the certificate and details of the job number and product codes registered.
• Communicate the registration number to stakeholders such as Logistics, Sales and Marketing, Customer Service, including the applicable Product Manager.

QUALITY RECORDS All documentation generated as a result of performing the activities relating to Product Registration, are to be considered Quality Records and are to be processed and archived in accordance with procedure for “Quality Records”.