Foreign Facility Registration
LK-Unique · Pre-requisite before product registration
Why Facility Registration Is Required
The NMRA requires all foreign manufacturing facilities to be registered with and approved by NMRA before any product registration application can be submitted. This site registration is a hard prerequisite — submitting a product registration without an approved manufacturing site will result in rejection.
This requirement is unique in the region — most Asian markets do not require separate facility registration before product submission.
Site Master File (SMF)
The SMF provides the NMRA with a comprehensive overview of the manufacturing facility:
| SMF Section | Contents |
|---|---|
| Site identification | Name, address, GPS coordinates, contact details |
| Premises description | Layout, zoning, cleanroom specifications |
| Organisational structure | Org chart, key personnel, qualified person details |
| Products manufactured | Categories of devices manufactured at the site |
| Manufacturing activities | Process overview, equipment list |
| Outsourced activities | Services contracted to third parties |
| Quality management system | QMS certification details, quality manual overview |
| Regulatory status | Approvals held in other countries; history of inspections |
On-Site Audit
Following SMF review, the NMRA may require an on-site audit of the manufacturing facility:
- Audit is conducted by NMRA inspector(s)
- Audit costs (travel, accommodation, per diem) are typically borne by the manufacturer
- Audit scope covers GMP compliance, QMS implementation, and facility adequacy
- Non-conformities identified during audit must be addressed before site approval is granted
Audit Waiver — SRA Inspection or WHO PQ
An on-site audit may be waived if the manufacturing site has been:
-
Inspected by a Stringent Regulatory Authority (SRA) within a specified recent timeframe:
- FDA (US) · MHRA (UK) · TGA (Australia) · EMA (EU) · Health Canada · PMDA (Japan)
- Provide the SRA inspection report or equivalent inspection confirmation document
-
WHO Pre-Qualified (WHO PQ): A current WHO PQ status for the relevant product/facility serves as audit waiver evidence.
Documentation to provide for waiver:
- Copy of most recent SRA inspection report (or confirmation of inspection)
- Correspondence from the SRA confirming no critical findings that would prevent use of the site
- Alternatively, current WHO PQ certificate and scope document
Site Approval Validity
NMRA site approval has a defined validity period. The MAH must ensure the site approval is renewed before expiry to maintain eligibility for continued commercial importation. Changes to the manufacturing site (new building, process changes, major equipment changes) should be reported to NMRA.
Practical Planning
- Allow 3–6 months for the facility registration process if an on-site audit is required
- Start the facility registration process before preparing the product registration dossier
- For manufacturers with recent SRA inspections, the audit waiver process is significantly faster
- Multiple product registrations can reference the same approved manufacturing site — this fixed cost is shared across all products registered from that site