Section 51 (c) of the Tanzania Medicines and Medical Devices Act, Cap 219 requires manufacturers of medical devices and diagnostics to comply with current requirements of good manufacturing practice/ quality management system as a condition for registration of their respective products.
Henceforth manufacturers of medical devices and in-vitro diagnostic devices have to demonstrate that their products are manufactured in compliance with quality management system (QMS) requirements of current ISO 13485 standard which covers the principles of good manufacturing practices of medical devices.
It is mandatory that all manufacturers of medical devices and in- vitro diagnostic in class C and class D to be inspected and approved before product(s) manufactured from those sites are granted market authorization. Moderate to low-risk medical devices and in-vitro diagnostic manufacturing facilities are inspected at the discretion of the Authority, based on the inherent risk of their products.
The audits are designed to:
- determine conformance of a manufacturer's quality system with regulatory requirements;
- determine the effectiveness of the implemented quality system for the purposes of meeting specified quality objectives;
- ensure that corrective actions agreed in various audits have been implemented effectively;
- ensure that corrective actions agreed in the previous audit have been completed effectively;
- ensure that, the products are consistently manufactured according to agreed standards and specifications submitted during market authorization; and
- determine conformance of a manufacturer's quality system applicable to a specific device’s standards.
- Initial Audit: An initial audit shall be conducted to confirm conformance with current ISO 13485 Standards and shall be an audit of all elements of the quality system.
- Surveillance Audit: A surveillance audit shall be conducted for a previously audited facility and shall constitute of either a full audit or partial audit of the quality system.
- Special Audit: This Audit is conducted if significant changes occured to a manufacturer which have been submitted or become known to TMDA and which could affect the decision on the manufacturer’s state of compliance to the regulatory requirements
- Un-announced Audit: An unannounced audit shall only be carried out when there are justifiable concerns about implementation of corrective actions or compliance with regulatory requirements by the manufacturer.
The facility which will be deemed compliant will be issued a quality audit certificate and the facility with major observation will have to rectify the observed non-compliance and send the response to the Authority for review before a final outcome is determined. The certificate is valid for 3 years
- Lodge an application through Trader Portal (attachments: application form and site master files)
- The audit is normally carried out for two (2) days by two (2) TMDA inspectors; one of them is the lead and the other is the co-inspector. Sometimes observers may be present.
- Tentative plan for the audit is normally sent in advance to the manufacturer before the date of audit.
- At the end of the audit, the audit findings and agreed action (if applicable) between Auditors and key representative from the audited facility are signed.
- The final audit report will be sent to the applicant 30 days after conclusion of the audit.
The facility which will be deemed compliant will be issued a quality audit certificate and the facility with major observation will have to rectify the observed non-compliance within 6 months and send the response to the Authority for review before a final outcome is determined. The certificate is valid for 5 years
The authority may carry desk review in lieu of physical inspection if criteria set for desk review have been met.
Desk review criteria:
- Manufacturing facilities located in countries that are founding members of Global Harmonization Task Force GHTF, currently IMDRF (excluding China, Brazil and Russia).
- Facilities that have been audited and found complaint to ISO 13485 or its equivalent by; USFDA, TGA- Australia, Health Canada, Ministry of Health Japan, European Union, or WHO prequalified facilities.
- Facilities that have already been audited by TMDA and found to comply with requirements of ISO 13485 and TMDA Medical Devices Regulations (upon Authority discretion).
- Any reason(s) of public interest
For more details on disposal, read the Guidelines for Recall, Handling and Disposal of Unfit Medicines