View Procedure

Procedure Name

The Registration of Medical Device

Description

Category

Permit/license

Responsible Agency

Department of Import and Export Control

Address: 120, Norris Canal Road, Colombo 10, Sri Lanka

Phone: +94 11 2698896/7

Legal base of the Procedure

National medicines regulatory authority act, no. 5 of 2015

Required Documents

No.	Type of documents	Note
1	Application Form

Process Steps

Step 1	Submission of registration application and two samples of the product to NMRA
Step 2	Process the Application
Step 3	Issue letter for payment of processing fee provided the application is complete.
Step 4	Pay the fee
Step 5	NMRA issues a specific File number and an Acknowledgement to the customer
Step 6	Sreening process
Step 7	Evaluation to assess eligibility for registration
Step 8	Evaluator sends the evaluation report for review by a panel of three regulatory pharmacists in the NMRA
Step 9	Panel issue the reviewed report to CEO, NMRA
Step 10	NMRA issue the registration certificate

*This information may be subject to change in the future by the NMRA

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
SCHEDULE I- Information required for registration of a device.	SCHEDULE I- Information required for registration of a device.	05-07-2018	05-07-2018

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Registration of medical Device	Registration Requirement		Standard Operating Procedure For Registration Of Medical devices	The basis for the regulatory control comes from National Medicines Regulatory Authority Act, No. 5 Of 2015	National Medicines Regulatory Authority Act	31-12-9999	Good