Section 51 (c) of the Tanzania Medicines and Medical Devices Act, Cap 219 requires manufacturers of medical devices to comply with current requirements of good manufacturing practice/quality management system for medical devices for their devices to be registered. 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 high-risk medical devices and diagnostics (class C and class D) 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.
Quality Audit Objectives
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
- determine conformance of a manufacturer's quality system applicable to a specific device’s standards.
Types of Quality Audits carried out by TMDA to medical devices and diagnostic devices manufacture include:-
- Initial Audit: An initial audit shall be conducted to confirm conformance with current ISO 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 there is significant changes occur 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 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 authority may carry desk review in lieu of physical inspection if criteria set for desk review have been met.
To apply for quality audit of medical devices and diagnostic devices manufacturer online click here.
For offline option applicant will be required to submit to TMDA office the following documents in soft copy and hard copy: -
- Quality Audit application form which is dully filled in, signed and stamped.
- Site Master File (SMF) which has been compiled in accordance to the template of site master file.
- Audit inspection fees as stipulated in fees and charges regulations in force.
Manufacturer/ and applicant of quality audit should expect the following: -
- The audit is normally carried out for two (2) days by two (2) TMDA inspectors which is four (4) days man job. Sometimes observers may be present.
- Tentative plan for the audit is normally sent in advance to the manufacturer before the day of the audit.
- At the end of the audit, signing of the audit findings and agreed action (if applicable) between Auditors and key representative from the audited facility.
- 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 and send the response to the Authority for review before a final outcome is determined.
The validity for Quality Audit Compliance certificate is Three (3) years, after which it is subject for renewal. To apply for renewal of the approved facility click here.