REGULATORY AUTHORITY: National Medicines Regulatory Authority (NMRA)
CLASSIFICATION SYSTEM:
Medical Devices: Listed Device/I/IIa/IIb/III
IVDs: A/B/C/D
TIMEFRAME: New full product registration will take a minimum of 6 months.
SPECIAL REQUIREMENT: Foreign manufacturing facility must be registered to and approved by NMRA. An on-site audit may be necessary, but NMRA would exempt on-site audit if the site had been inspected by a stringent regulatory authority or WHO.
Two (2) product samples will be required as part of the registration. Therefore, import license will be required to import the sample. The approval of foreign manufacturing facility, however, is required as the pre-requirements to apply for such import license.
Local testing is required for the following type of devices:
- Devices which are in contact directly with the blood stream.
- Plasters, gauze, sanitary napkins, bandages, latex condoms, surgical and examination gloves etc.
- Feeding bottles, toothbrush, and medical gas cylinders.
Approval from Atomic Energy Authority of Sri Lanka is required for radiation emitting devices.
LOCAL FEES (New Application)
New product registration
Processing fees: USD 1000
Additional data evaluation: USD 500
Certificate registration issuance: USD 400
Sample import license: USD 100
Import license: USD 100
Foreign Manufacturing Site Approval
Processing fees: USD 1500
Additional data evaluation: USD 500
On-site Inspection: USD 15000 (SAARC Countries*); USD 20000 (other countries)
*SAARC countries is the regional intergovernmental organization and geopolitical union of states in South Asia. Its member states are Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan and Sri Lanka.
LOCAL FEES (Manufacturer): Additional fee will be required for foreign manufacturer on-site audit.
LICENSE VALIDITY:
Provisional registration certificate – 1 or 2 years
Full registration certificate – 5 years
Import license – 1 year
LICENSE TRANSFER: Transferring registration certificate from one MAH to another MAH is possible and application to NMRA is required.
AUTHORIZED REPRESENTATIVE: All foreign medical device manufactures must appoint a Marketing Authorization Holder in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular medical device in Sri Lanka.
ADDITIONAL INFORMATION: Each new product will always be granted a 1-year provisional registration certificate. This certificate will be valid for 1 or 2 years. NMRA will mention if they require any additional information/documentation. After furnishing all additional request to the authority, the full registration certificate with a longer expiration date will be granted.
Other Central & East Asia Countries: Afghanistan, China, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Taiwan, Tajikistan, Uzbekistan, Pakistan, India
