MEDICAL DEVICE MANUFACTURERS EVIDENCE WORKSHOP
Training and Workshops
COURSE STRUCTURE
The workshop consists of real-world case scenarios, supported by a series of mock-up manufacturer’s certification and checklists based on the requirements of the Australian legislation and Medical Device Regulations.
Participants are welcome to bring along their own medical device manufacturers certification to gain confidence in “self- assessing” a certificate prior to submitting the document to the TGA.
AIM
To build competence in submitting appropriate manufacturers evidence to the TGA
TOPICS COVERED
- How to avoid the pitfalls in submitting incorrect manufacturer’s certification;
- What type of manufacturers evidence is required for a specific class of medical device;
- What to look for to ensure the manufacturer’s evidence is appropriate;
- What is meant by multiple annex route certification;
- When to and when not to apply for a variation to manufacturers evidence when there has been a change to the EC Certificate such as:
- Expansion of the range of products covered under the scope of the certificate;
- Reduction in the range products covered under the scope of the certificate;
- An update of the certificate number or re-issue date;
- Alteration of the conformity assessment procedures (change to the Annex route);
- A change to the Notified Body undertaking the audit; and
- an amendment to the manufacturer’s details (change to name and/or address).
- What documentation is required for a variation to manufacturer’s evidence and from where is this information sourced.
DURATION: HALF DAY