Uzbekistan GMP and ISO:13485 Certificate Requirements: Key Dates to 2027

1. Key takeaways

Presidential Decree No. UP-137 elevates the quality system certificate from a supporting document to a certificate-of-conformity threshold, with two dates: from January 1, 2027, obtaining a certificate of conformity for medicinal products requires a national GMP certificate for each type of medicine produced; and from July 1, 2027, obtaining a certificate of conformity for medical devices requires a certificate of conformity with the national standard ISO:13485. On the medicinal products side the national GMP certificate requirement arrives even earlier: from January 1, 2026, national registration of medicines and renewal of registration certificate validity already require it. The decree also defines four categories of exemptions, several of which can substantially change the compliance burden for device manufacturers that already hold foreign approvals.

Because a certificate of conformity is the document that unlocks placing a device on the market, the July 1, 2027 threshold effectively converts quality system certification from a voluntary asset into a market access prerequisite. Certificates take time to prepare, audit, and recognize, and the local recognition or conversion step is outside the manufacturer’s direct control, so the working assumption should be that the entire chain needs to be complete well before the deadline rather than started within it.

2. Legal basis

3. Expert insights

Insight one: the three dates belong to three separate lines and should not be merged into one memory. January 1, 2026 is the GMP requirement for medicine registration and renewal; January 1, 2027 is the GMP requirement for the medicine certificate of conformity; and July 1, 2027 is the ISO:13485 requirement for the device certificate of conformity. Device manufacturers need to back-plan only from July 1, 2027, but combination products that contain both a medicine and a device must check the first two dates as well.

Insight two: note that the requirement refers to national certificates; international certificates do not take effect automatically. The decree speaks of a national GMP certificate and a certificate of conformity with the national standard ISO:13485. This means that an ISO 13485 certificate issued by an international body may need to pass a local recognition or conversion procedure. Manufacturers should schedule around obtaining a system certificate recognized in Uzbekistan rather than treating possession of an international certificate as the finish line.

Insight three: among the four exemptions, the recognition pathway and WHO prequalification are the most useful for device manufacturers. Products registered through the simplified procedure of the recognition pathway, and products prequalified by WHO, do not need to submit GMP or ISO:13485 certificates. This matches the overall design logic of the recognition pathway: mature foreign regulatory evidence can replace the repeated verification of a local system certificate. For manufacturers in the Chinese mainland that already hold approvals in Europe or the United States, this is a substantive burden-reduction channel.

Insight four: system requirements are already permeating the registration stage and the post-market stage ahead of the deadline. Under Resolution No. 738, manufacturing condition inspections on the general pathway may be assessed by reference to national standards harmonized with ISO 13485; under Resolution No. 628, an ISO 13485 conformity assessment of the manufacturer may be required when post-market surveillance finds nonconformity. Even before July 1, 2027, the state of the quality system is already influencing registration and post-market outcomes.

4. Practical recommendations

1. Back-plan the acquisition of the national ISO:13485 certificate of conformity from July 1, 2027, reserving time for local recognition or conversion.
2. Check the applicability of the four exemptions first, especially the recognition pathway and WHO prequalification.
3. For medicine-device combination products, verify the medicine-side requirements of both January 1, 2026 and January 1, 2027.
4. Align the scope of the system certificate (manufacturing sites, product families) with the scope of the registration submission, to avoid gaps in coverage.
5. Maintain the quality system to ISO 13485 before the 2027 deadline, so that registration inspections and post-market assessments can be handled without urgency.

5. Verification checklist

• □ The acquisition plan for the national ISO:13485 certificate of conformity is back-planned from July 1, 2027
• □ The applicability of the four exemptions is checked one by one
• □ Combination products are checked against the medicine-side dates of January 1, 2026 and January 1, 2027
• □ The scope of the system certificate matches the manufacturing sites and product families in the registration submission
• □ It is confirmed that the system certificate must be a national certificate, and international certificates require local recognition or conversion
• □ Before the 2027 deadline, the quality system is maintained to ISO 13485 to handle inspections and assessments

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including quality system certification planning against the 2027 thresholds. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.