To all Local Medical Device Manufacturers

Notice Regarding GMP Inspection Waiver for Listed and Class 1 Medical Device Manufacturing Sites

The National Medicines Regulatory Authority (NMRA) has decided to waive the GMP inspection requirement for manufacturing sites involved in the production of Listed and Class 1 medical devices (refer to the attached list & Annexed 1). 

Manufacturers may now apply for product registration without prior GMP approval, provided the following criteria are met:

Submission Requirements:

Manufacturers must submit the following documents to the Manufacturing Regulatory Division (MFRD) on Thursday: 

Site Master File with, 

• Business Registration Information 
• Site Layout 
• Brief Description of Manufacturing Activities 
• List of Products intended to be manufactured at the facility

GMP Waiver Process: 

Upon review of the submitted documents, the MFRD will issue a GMP Waiver Document. This document must then be submitted along with the product registration application in place of GMP approval.

NMRA has granted two years blanket GMP approval to allow the relevant manufacturers to obtain ISO 9001 for the above category of products with effect from 10/05/2025 to 09/05/2027 

After 09/05/2027 NMRA will only accept ISO 9001 in lieu of GMP inspection for the above categories.

For any inquiries, please contact the Manufacturing Regulatory Division

CEO/NMRA

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