Foreign Facility Registration

LK-Unique · Mandatory pre-requisite to product registration

Overview

All foreign manufacturing sites must be registered and approved by the NMRA before any product registration application can be submitted. This requirement — unique in the region — means that market entry planning in Sri Lanka must start with facility registration.

Site Master File (SMF) Contents

Section	Required Information
Site identification	Facility name, address, GPS location, contact details
Premises	Description of buildings, zoning (manufacturing, QC, storage), cleanroom specifications
Organisational structure	Organisation chart, quality roles, qualified person(s)
Products manufactured	All product categories manufactured at the site
Manufacturing activities	Process summary, key equipment, outsourced activities
Quality system	QMS standard (ISO 13485), certification details, last internal audit
Regulatory history	Approvals held in other countries; history of regulatory inspections
Recent deviations	Any significant non-conformities from recent audits

On-Site Audit Process

1. MAH submits SMF to NMRA Medical Devices Regulatory Division
2. NMRA reviews SMF and determines if on-site audit is required
3. NMRA schedules audit — manufacturer notified in advance
4. NMRA inspector(s) conduct on-site audit:
   • GMP compliance review
   • QMS implementation assessment
   • Facility and equipment inspection
   • Personnel interview
5. Audit report issued with any findings
6. Manufacturer addresses non-conformities
7. NMRA issues site approval letter

Audit costs (NMRA inspector travel, accommodation, per diem) are borne by the manufacturer/MAH.

Audit Waiver — Evidence Required

An on-site NMRA audit may be waived with evidence of:

Option 1 — SRA Inspection:

• Copy of the most recent inspection report from an SRA
• SRA = FDA (USA) · MHRA (UK) · TGA (Australia) · EMA (EU) · Health Canada · PMDA (Japan)
• Report must be recent (typically within 2–3 years — confirm current NMRA requirements)
• Report should show no critical findings that would prevent continued manufacture

Option 2 — WHO Pre-Qualification:

• Current WHO PQ certificate and scope document covering the relevant product category

Waiver application: Submit waiver request with supporting evidence to the NMRA Medical Devices Regulatory Division.

Site Approval Validity and Renewal

• NMRA site approval has a defined validity period
• Renew before expiry to maintain eligibility for continued product registration and importation
• Changes to the manufacturing site (new buildings, major process changes, relocation) must be reported to NMRA promptly

Planning Timeline

Activity	Estimated Duration
SMF preparation	4–8 weeks
NMRA SMF review	4–8 weeks
On-site audit scheduling and conduct	4–12 weeks
Non-conformity resolution and site approval	2–8 weeks
Total if audit required	14–36 weeks
Total with audit waiver	8–16 weeks

Start facility registration before preparing the product registration dossier — particularly if an on-site audit is likely.