Persatuan Perkilangan Peranti Perubatan (PERANTIM)
Malaysian Medical Device Manufacturers Association
(PPM-023-10-19112018)
Qualifying Criteria
- Medical device manufacturer with a minimum of 51% ownership by a Malaysian, with the company director and factory based in Malaysia.
- Where the definition of manufacturer and medical device is in accordance to the Medical Device Act 2012.
- Preferably registered with Malaysian Medical Device Authority, under the purview of the Ministry of Health Malaysia.
- In compliance to ISO 13485.
- Qualifying criteria may change in accordance to the decision made by the committee.
- Application for memberships is subject to the collective decision amongst the selected committee members.
Types of Membership
- Full Member:
- Satisfies all of the requirements under the Qualifying Criteria.
- Associate Member:
- For applicants who partially meets the Qualifying Criteria.
- Companies that are indirectly involved in Medical Devices.
Important Notes
- We are a newly formed association and we may seek additional information from time to time. Particularly from the company representative mentioned in the application form.
- The annual fee will be ONE THOUSAND MALAYSIA RINGGIT (RM1000.00). Banking details will be sent to companies once application is approved via email as registered in this online application form.
- The following documents MUST be submitted along with this online application form:
- Form 9
- Form 49
- MDA Certificate
- ISO 13485 Certificate
For further enquiries, contact PERANTIM SECREATARIAT:
ELAINE HEW
WhatsApp: https://wa.me/60123349341
Email: perantimm@gmail.com