GMP Technical Instructions and Quality Management System Documentation

1. Key takeaways

Macao, China does not impose a single generic GMP covering all devices; instead it has issued six technical instructions by device type: Ruling No. 16/ISAF/2026 on the Good Manufacturing Practice for Medical Devices (GMP) (general provisions), No. 17 on the GMP for Customised Dentures, No. 18 on the GMP for Sterile Medical Devices, No. 19 on the GMP for Implantable Medical Devices, No. 20 on the GMP for In Vitro Diagnostic Reagents, and No. 21 on the GMP for Standalone Medical Device Software. In addition, Ruling No. 22/ISAF/2026 on the preparation and technical requirements of quality management system documentation for medical device manufacturing activities serves manufacturing licence applications.

• Six type-specific GMP rulings plus one general ruling cover the manufacturing landscape.
• Ruling No. 22/ISAF/2026 defines how the quality management system file for a manufacturing licence must be compiled.
• Existing quality system documents of manufacturers from the Chinese mainland can be reused after mapping (practical estimate).
• Standalone software has its own GMP: software development is treated as a manufacturing activity.
• GMP compliance is a continuing, inspectable obligation tied to the manufacturing licence, not a one-off submission.

2. Legal basis

The GMP obligations are distributed across six ISAF rulings of 2026, all in force from 1 July 2026, supplemented by the ruling on quality management system documentation and by the Implementation Rules, which require a quality management system file for manufacturing activities as part of the manufacturing licence application.

3. Expert insights

First observation: the granularity of the six GMP rulings shows that ISAF intends to conduct substantive review. Issuing separate standards for sterile devices, implantable devices, in vitro diagnostic reagents, standalone software and customised dentures closely resembles the structure of the GMP for medical devices of China and its annexes. Existing quality system documents of manufacturers from the Chinese mainland show a high degree of reusability after mapping (practical estimate). The task is one of structural translation — reorganising existing procedures to the headings the ISAF rulings expect — rather than writing a new system from zero.

Second observation: a standalone GMP for software means software is treated as a manufacturing activity. Ruling No. 21/ISAF/2026 establishes a GMP for standalone medical device software, an arrangement that is comparatively forward-looking in the region — the software development process is brought within the scope of quality management system review, and not merely the testing of the final product. Software companies should therefore expect reviewers to look at lifecycle documentation, release management and maintenance processes, not only at the artefact that is placed on the market.

Third observation: the GMP is tied to the manufacturing licence, not to product registration. The Implementation Rules list the quality management system file for manufacturing activities among the manufacturing licence application documents, with the compilation requirements set by Ruling No. 22/ISAF/2026. Where an overseas manufacturer has a Macao entity apply for registration through commissioned manufacture, the GMP obligations fall on the commissioned manufacturer (Article 36 on commissioned manufacture). This allocation matters when the overseas principal and the local contract manufacturer are separate compliance organisations.

Fourth observation: ISAF checks GMP compliance when renewing the manufacturing licence. The licence renewal provisions of the Implementation Rules state that, for the renewal of a manufacturing licence, ISAF shall inspect the medical device manufacturer to verify its compliance with the relevant good manufacturing practice. GMP is thus a continuing obligation that can be examined on site, not a document submitted once. Records, premises and personnel qualifications must remain in an inspection-ready state throughout the licence period, because the inspection occurs exactly when the business most needs the licence renewed.

4. Practical recommendations

• First determine the applicable GMP rulings by device type: the general ruling plus possibly several specific rulings, checked one by one.
• Map mainland quality system documents rather than rewriting them: restructure them to the framework of Ruling No. 22/ISAF/2026 while preserving the original records.
• Software companies should build their system on the standalone software GMP: bring the development lifecycle within the scope of quality management.
• Maintain the GMP in an inspectable state: a site inspection precedes renewal of the manufacturing licence, so records and facilities must remain continuously compliant.

5. Verification checklist

• □ The applicable GMP rulings have been determined by device type (No. 16 and the applicable specific rulings)
• □ The quality management system file has been compiled under Ruling No. 22/ISAF/2026
• □ Software products have a system built on Ruling No. 21/ISAF/2026
• □ In commissioned manufacture, the commissioned party has been confirmed as GMP compliant
• □ Preparation has been made for the site inspection at renewal of the manufacturing licence
• □ GMP compliance records have been retained continuously

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Macao, China. Our team prepares SSM-compliant dossiers, coordinates language and legalisation requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com