How To Register A Medical Device Company

Frequently Asked Questions - Registration, Licensing & Enforcement

FAQs - Registration, Licensing & Enforcement

Frequently asked question well-nigh Registration, Licensing & Enforcement

Please refer to document:
MDA/GL No. two - How to employ for institution License under medical device human activity 2012 ( Human action 737)

Please refer to document:
MDA/GL/004 - Awarding For Renewal Of Institution License

All establishments, ie manufacturer, authorised representative (AR), importer and benefactor must apply for establishment licence. Still, just manufacturer and AR demand to apply for medical device registration.

A distributor is a person or company appointed by an AR (for medical device manufactured in foreign land) or a manufacturer (for locally manufactured medical device) to further medical devices registered past the AR or the manufacturer into the Malaysian market. A benefactor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an institution license to bear its activity.

A benefactor is a person or company appointed by an AR (for medical device manufactured in foreign country) or a manufacturer (for locally manufactured medical device) to further medical devices registered past the AR or the manufacturer into the Malaysian market. A distributor shall just distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to behave its action.

There is no issue if the name of the distributor differs with the name of the manufacturer. However, an AR cannot be the make owner.

Diverse people or entities who are responsible for procurement, transportation, delivery, storage, device tracking, installation, commissioning, service, maintenance and calibration, need to be appropriately managed and regulated to ensure safety and operation of medical devices at the bespeak of employ. The level of risks associated with these activities may be of similar degree as those in the manufacturing surround and the lack of command over these activities may affect safety and functioning of the devices. GDPMD specifies the requirements for a quality management system (QMS) to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with medical device regulatory requirements as stipulated in Deed 737 and its subsidiary legislations. GDPMD requires an establishment to demonstrate its ability to maintain quality, condom and performance of medical devices in compliance with the regulatory requirements throughout the supply-chain. The requirement for GDPMD is stipulated as the QMS requirement for those involved in medical device supply chain, namely the AR, importer and distributor as required para xi of 3rd Schedule of MDR2012.

GDPMD is a requirement for institution licensing of benefactor. It is a type of QMS to ensure the safety

and performance throughout the medical device supply chain. The GDPMD volition be assessed and certified by

the CAB. The certificate issued past the CAB shall be submitted equally role of the requirements for establishment

license application.

Only certain non-confidential information on licensed establishments and registered medical devices will be made available for public access. Sections 67, 68 and 69 of Human action 737 and Regulations 21 and 22 of MDR2012 give the provisions on how the Dominance shall handle the information.

No, equally long as they do not involve in whatever activities related to distribution. Tendering agent are strictly for the purpose of procurement with the government hospital

Y'all may asked for the copy of establishment licensing certificate directly from your manufacturer/ Authorized representative (AR) / distributor. It is a requirement for Ministry building of Health procurement sectionalization to ascertain that this products are from a licensed establishment and registered. MDA will not provide whatsoever alphabetic character for tendering amanuensis. If they are nevertheless facing a problem, the tendering agent may call directly to MDA.

Requirement for CAB recognition must be from a local CAB in Malaysia that are registered nether Section 10, Act 737.

For manufacturer, it is required to have ISO 13485, not GDPMD

Please write an official alphabetic character to MDA to notify u.s.a. on this

Establishment tin apply establishment license once they become provisional certificates. Establishment need to update MDA once they get full certificates.

If the distributor is not licensed, then, as AR, you are responsible to not appoint the establishment as your distributor.

If our Singapore office staff is handling everything in Singapore, is this adequate? Answer If the medical device is identify in Malaysia market, then it is subjected to Human action in Malaysia. AR must have licensed and habitation in Malaysia

MDA volition refer to legal manufacturer simply.

Answer MDA will take action to the individual involve, not just the establishment under Malaysian deed

No, you have to get the scope for implantable