ANVISA recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. Sponsors will need to submit Medical Device Clinical Dossier clinical (DICD). This resolution will be applicable to all clinical trials with medical devices for registration in Brazil.
DICD is compilation of documents to be submitted to ANVISA to evaluate the steps inherent to the clinical development of a medical device under investigation and to guarantee the safety and the rights of clinical trial participants at all stages of clinical development.
DICD is required for products:
- Risk class III or IV
- Supply energy to the participant
- Confirm diagnosis
Here are some requirements for DICD:
1. Sponsor should submit DICD to ANVISA if it intends to perform clinical investigation for the purposes of registration in Brazil.
2. If ANVISA does not provide any comments on the DICD within 90 calendar days then the sponsor can begin the investigation after ethical approvals.
3. DICD application shall contain:
a. Request form
b. Proof of payment
c. Clinical investigation plan
e. Summary of safety based on previous clinical investigation of the devic
f. Dossier of the medical device
g. Specific dossier of clinical trial to be performed
h. Proof that clinical investigation is registered in the International Clinical Trials Registration Platform/World Health Organization (ICTRP/WHO) or other international recognized database
4. DICD must be submitted physically along with an electronic media (pdf or word file).
5. All modifications, deviations, adverse events related to the clinical trial must be reported to ANVISA.
6. Once a DICD has been cancelled, no clinical investigation related to it may be continued.
7. Clinical Investigations must be in accordance to Good Clinical Practices (GCP).
8. Sponsor shall submit annual clinical development reports to ANVISA including adverse reporting, changes to medical device design, and results of ongoing clinical investigations worldwide.
9. ANVISA may perform GMP inspections of the medical device under investigation.
10. In order to import the device under investigation to Brazil, the following documents must be presented to Sanitary Authority:
a. Copy of the Special Communique (CE) for DICD
b. Copy of the Cargo through which the device will arrive
c. Copy of commercial invoice
d. CE Certificate or Certificate of Free Sales
e. Label must include:
i. Storage and Transportation conditions
ii. Shelf life
iii. Lot and Serial Number
iv. Quantity of imported material
v. EC number