Business Process Plan concerning MOH Malaysia

[somashekar]

Company A is in India and makes class IIB medical device and have obtained CE thru an NB, and is also ISO13485 certified.

Company B is in USA and has an OBL CE based on the CE of company A, and is also ISO 13485 certified. Company B also has the 510(k) for these devices.

Company C is in Malaysia and is also the manufacturing outsource location of Company A. They are in the process of Establishment Licensing and Medical Device Registration per Act 737 of Malaysia Ministry of Health. Company C is ISO 13485 certified as contract manufacturer but not with a CAB recognized by the MOH Malaysia.

Company C wants to manufacture some of the class IIB devices and label with the CE of company B. and place in the market in Malaysia. Company C also wishes to sell these devices in Taiwan, Sri Lanka, Cambodia, Vietnam, Laos, Burma, Thailand, Indonesia, Brunei, Philippines, and Singapore. Company C has the Certificate of free sale from the MOH Malaysia.

Company A and Company B is OK with this. (A, B and C are part of the same corporate)

What are the next steps each of the company must take further?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[somashekar]

Q: What are the requirements for medical device registration?
A: Medical device registration shall be made by the manufacturer of the medical device or the authorized representative (AR) in the case of medical devices that are manufactured in foreign country. To register a medical device, the manufacturer or AR shall:
(i) determine the class of the medical device according to First Schedule of Medical Device Regulations 2012 (MDR2012);
(ii) determine grouping for the medical device according to second Schedule of MDR2012;
(iii) conduct conformity assessment to demonstrate conformity of the medical device to the requirements in Third Schedule of MDR2012;
(iv) collect evidence of conformity of the medical device to all requirements;
(v) depending on the class of the medical device, appoint a conformity assessment body to conduct assessment on the conformity;
(vi) prepare Common Submission Dossier Template (CSDT) including its supporting documents for medical device registration submission;
(vii) prepare the Declaration of Conformity (DoC);
(viii) pay application and registration fees accordingly;
(ix) make application submission via MeDC@St.
You are advised to refer to Sections 5 and 6 of Act 737 and Part III of MDR2012 for more detailed requirements.

Q: What documents of QMS shall be submitted for medical device registration?
A: ISO 13485 certificate issued by registered CAB shall be submitted for registration of medical devices. For further information on the requirement of QMS for medical device registration, please refer to Third Schedule of MDR2012.

Q: Please provide list of certification bodies approved by MOH so that we can begin preparation for our branch in Malaysia.
A: The list of CAB is available on our website. Besides the list of CAB, you will also find other useful information.

The above is a part of the FAQ from the MOH site <www.mdb.gov.my> Click here
So if you want to do business in Malaysia, then you have to ensure that your ISO 13485 CB and NB where necessary are on the recognized CAB list in Malaysia... ??
How this can be made to happen. For the sake of Malaysia, you have to change your CB / NB .. or additionally work with MOH recognized CAB apart from your existing CB / NB ??

 

[sreenu927]

Hi Somashekar,

If Company C wants to manufacture Class IIb devices and label them with Company B's CE marking, then I assume, Company B is the product owner with Company C as contract manufacturer.

For Company C to sell in Malaysia: Company C will be the Importer, Distributor and Authorized Representative for Company B, since the product owner is Company B.
Next steps: Obtain Establishment License with Medical Device Authority (MDA). To obtain Establishment License, they need to appoint Conformity Assessment Body (CAB) to assess their Quality Management System or GDPMD; as they already have ISO 13485, check with MDA whether they accept it or need to have a separate CAB listed with MoH. Company B should give Letter of Authorization (LOA) to Company C.
Upon obtaining Establishment License, submit for product registration and can sell.

In other SEA/Asian Countries (per your list): Company B is the product owner (or legal manufacturer). Company B should have local contact (distributor, in the absence of their presence in local) and have an agreement with them. Either Company B or C (since they are part of same corporate) can provide documentation support to register the product in those listed countries. The registration certificate could be on the name of distributor and some will have the name of Company B and some certs will have both Company B and C. For ex: Taiwan - the registration cert will have the name and address of both Company B and Company C, where the Quality System Documentation (QSD) approval will be for Company C.

Regards,
Sreenu

 

[sreenu927]

If your question is limited only to having Registration Body that is not from the list of CABs by MoH, then I'l check and get back to you.

Regards,
Sreenu

 

[moups]

Dear Sreenu,
I am not sure whether you've got answers to all your questions about registration and licensing in Malaysia.
If not, please confirm and I would be happy to clarify.
Mourad
Andaman Medical

 

[sreenu927]

We need to have the CAB that has been approved by MDA, Malaysia. But not to issue ISO 13485; but to verify GDPMDS requirements for importers and distributors and review the technical documentation.


Hi Mourad - Welcome to Cover. Please feel free to provide your opinion.

Regards,
Sreenu

 

[moups]

Hi Sreenu,
Your ISO13485 certificate can be issued by any Notified/Certification Body, but as a manufacturer you wil need one of the 8 approved CABs to conduct conformity assessment procedure.
Your importer, distributor and LaR need a CAB to conduct GDPMD assessment in order for them to obtain an establishment license.
Hope this helps,
Mourad
Andaman Medical

 

[sreenu927]

Hi All,

Malaysian Regulatory Authority has released five (5) circulars related to Medical device regulations. One of them is List of low risk (Class A) products exempted from registration. The second is that the Authority is considering the GHTF approvals for Abridged Route - this will reduce the review time by Conformity Assessment Bodies (CABs) and in turn shorten the approval times.

The details of all circulars can be found at the below link:
http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=205

Attached is the exempted list for product registration.

It is mentioned that:
Section 6) i) Exemption from registration requirements under the Medical Device Act 2012 (Act 737) for medical devices in the following categories subject to conditions to be imposed from time to time:
a) Low risk medical devices as listed in Appendix 1.

On the last page
* All Class A medical devices that are non-active, non-sterile, and has no measuring function are considered to be low risk medical devices and are exempted from registration requirement.

Regards,
Sreenu

 

[Murni Ahmad]

Hi,

Sorry to bump in.
I am looking for any update on GST charge for Medical Device.
Do you happen to have any update on this?

Plus,
I understood that there are no import duty on Medical device so far. Am i missing any relevant charge for medical devices? Any kind of tax maybe?

Thank you.