Medical Device Authority of Malaysia (MDA) has announced the amendment of requirement establishment license renewal on 13 December 2022 (Refer here) . The amendment relates to point of 1.8 which stated that licensee holder must apply license renewal 90 days at least prior to expiration date. This amendment applies to all local manufacturers, authorized representatives, distributor and importer in Malaysia. The term is under Section 15 act of 737.
Late license renewal more than 90 days from any establishment will not be accepted and the establishment will have to undergo new license application. MDA also highlighted that any fee paid prior to late license renewal is non-refundable.
In general, establishments have to obey all the listed regulatory requirements by MDA. Among the terms are listed below:
1. Establishment information must be provided by licensee when requested by the authority.
2. MDA holds the authorized right to scrutinize the establishment at any time with or without notice.
3. License must be present on clear space and presented to the authority when requested.
4. License validity is subject to the license validity period and terms of quality management system certificate issued by Compliance Assessment Body.
5. MDA entitled to revoke or suspend any establishment license if licensee fail to obey the terms and conditions.
6. Licensee should not allow any misuse of establishment license.
7. Licensee cannot allow or proceed any import, export or place products in unauthorized medical device market from manufacturer or authorized distributor.
8. Any changes on license information should be informed and received approval by authority.
9. Licensee also must report to MDA for any new appointment letter or call off agreement by authorized distributor, importee or manufacturer.
10. Any authorized distributor that willingly to take over any medical device registration should receive agreement from current authorized distributor.
Establishments that fail to obey any terms, as provided in Act 737 Section 19 (1) meanwhile in Section 19 (2) mentioned license holder who violating Section 19 (1) may be fined up to RM 100, 000 or imprisoned maximum 1 year or both. Original list of establishment terms can refer here.
Contact us info@arqon.com for more information.