TMDA Becomes an MDSAP Affiliate Member: Scope and Limits

1. Key takeaways

On 13 September 2026, the MDSAP Regulatory Authority Council (RAC) unanimously agreed to admit TMDA as an MDSAP Affiliate Member; the MDSAP website published a notice on 16 September 2026; and TMDA issued a public notice on 24 September 2026 confirming the development.

According to TMDA’s official wording, affiliate membership brings three concrete capabilities:

1. Access to official MDSAP audit reports and related quality management system (QMS) certification information;
2. Access to the directory of MDSAP participating facilities — information on shared manufacturing sites, audit dates and the responsible MDSAP Auditing Organizations (AOs);
3. Using this to strengthen TMDA’s desk review capability for manufacturers’ QMS compliance, reduce unnecessary duplication of regulatory audits and optimise the allocation of regulatory resources.

But the boundary must be stated clearly: affiliate membership does not affect product registration itself, nor does it automatically bring Tanzania’s national requirements into the scope of MDSAP audits.

For manufacturers, the practical meaning is narrower than the headline suggests. What has changed is TMDA’s ability to verify and use audit information it could already request; what has not changed is the substantive pathway for any particular product, and the criteria that decide whether a site is audited on paper or in person.

2. Legal basis

3. Expert insights

Insight 1: The official notice frames the purpose narrowly — desk review, not exemption from audit.

The original text of the TMDA notice states that access to this information “will significantly strengthen TMDA’s ability to conduct efficient and effective desk reviews of manufacturers’ QMS compliance”, and that by leveraging MDSAP audit results and existing regulatory information, “TMDA can reduce unnecessary duplication of regulatory audits”. The wording is reduce duplication, not waive. Reading this as automatic audit exemption for certificate holders is an over-interpretation, and planning an application on that assumption creates avoidable rework.

Insight 2: MDSAP audit reports were already acceptable desk review evidence well before 2026.

§7.2.2.4 of the quality audit guidelines requires submission of “notarized copies of audit reports issued within the past 3 years by SRAs, notified bodies, MDSAP, any other regional harmonization initiative and/or the WHO prequalification programme”. In other words, the listing of MDSAP reports as evidence is an existing rule, not a 2026 addition. What changed in 2026 is that TMDA itself now has an official channel to verify the authenticity and scope of those reports.

Insight 3: Affiliate membership and the exclusion of China operate in parallel without contradiction.

§7.2.1.4 of the quality audit guidelines excludes Brazil and China under the MDSAP item, and TMDA’s accession to MDSAP did not change that wording. Chinese manufacturers therefore cannot infer from TMDA’s admission to MDSAP that they may proceed by desk review. The two provisions must be read together, and the exclusion language continues to control the eligibility analysis.

Insight 4: The MDSAP participation structure defines the limits of affiliate rights.

The full (voting) members of MDSAP are the US FDA, Australia’s TGA, Brazil’s ANVISA, Canada’s Health Canada and Japan’s MHLW/PMDA. Affiliate members are regulatory authorities that participate in and make use of MDSAP audit reports and certificates, and evaluate applicable requirements within their own national regulatory frameworks. Affiliate members do not require Auditing Organizations to additionally cover their national regulations during MDSAP audits; whether to accept the audit results and whether to add an on-site audit is decided by each affiliate member itself.

Insight 5: An MDSAP certificate cannot replace product registration.

MDSAP audits target the manufacturing site: certificates are issued per production address, not per product, and they attest that the site’s QMS conforms to ISO 13485 and to the QMS regulatory requirements of the full members. Products still need to obtain registration or notification separately under the Tanzanian process, with its own dossier, fees and review timelines.

4. Practical recommendations

1. Read the MDSAP status as an improvement in the credibility of system evidence, not as a basis for shortening the product review cycle.
2. Manufacturers already within the MDSAP system: update the system evidence package in the Tanzanian submission, highlighting MDSAP audit reports from the last 3 years (§7.2.2.4 requires notarized copies).
3. Chinese manufacturers should not change their scheduling on this basis; continue to prepare along the on-site audit route described in article 13.
4. Track whether TMDA issues operational rules on the acceptance of MDSAP reports — the notice itself states principles only, without concrete decision criteria.

5. Verification checklist

• □ Confirmed that TMDA issued the public notice on 24 September 2026, with the RAC decision dated 13 September 2026.
• □ Aware of the three affiliate capabilities: access to audit reports, access to the facility directory, and strengthened desk review.
• □ Aware of the boundaries: it does not replace product registration, it does not automatically cover Tanzania’s national regulations, and TMDA retains the right to add an on-site audit.
• □ Aware that §7.2.1.4 excludes Brazil and China under the MDSAP item.
• □ Notarized copies of system audit reports from the last 3 years prepared in the submission package (where applicable).

Regulatory information verified as of 29 October 2026. All content cited in this document was checked against the TMDA public notice of 24 September 2026 and the quality audit guidelines §7.2.1.4 and §7.2.2.4, and will be re-checked when the regulations are updated.

• Tanzania local resources: licensed Local Responsible Person (LRP) and distributor resources can be coordinated to cover online submission, sample delivery, quality audit cooperation and port clearance.
• Service capabilities: classification determination, registration and notification pathway selection, technical documentation (CSDT/STED) preparation and localization, GMDN and grouping strategy, clinical evidence organization, software and AI device submissions, change management, vigilance and PMS reporting, annual retention fees and renewal management.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.