The 6th ASEAN Medical Device Committee (AMDC) Meeting 3-6 April 2018

April 11, 2018

Questions for ASEAN 

 

General

  1. Can we have the slides from the regulators update?

  2. What changes can to AMDD can be expected with EU MDR and EU IVD update and when?

  3. What are the change notification procedures for the different countries (particularly for Vietnam and Philippines, etc.)?

  4. If the device is no longer being sold but there are still installed unit that require maintenance, does the device still need to be registered for the maintenance and importing of spare parts?

  5. What is the role of Notified Bodies in countries such as Thailand and Indonesia?

  6. How would product registration be affected if the product is no longer CE marked?

  7. Are software version numbers required to be stated in the approval licenses for the different countries (particularly for Vietnam, Philippines, Malaysia)?

  8. Why can’t all member States share your documents database to avoid repetitive submission from applicants? Then you still have different evaluation ways and just ask for docs not submitted.

  9. Products like toothbrushes, feminine pads and diapers are MD in countries like Indonesia, Thailand, how will these be looked past AMDD in countries where they are under household products or other c

  10. Is there special license for unregistered medical devices for compassionate use or for name patient basis?

  11. Is there minimum labelling requirements on the product itself? Or is labelling on just the market unit carton considered sufficient?

 

ASEAN

  1. Will the slide decks presented by the various ASEAN regulators be shared with the audience?

  2. Do any of the ASEAN countries have plans to adopt UDI requirements? Or will they be harmonized with the US & EU?

  3. Possible to have a MDSAP model in ASEAN? Single Window approval across ASEAN countries?

  4. There is discrepancy of understanding of “Product Owner” in some ASEAN countries (not Legal Manufacturer but own the product, trademark, PMS etc). Will this be harmonized and discuss within AMDC

  5. With the upcoming EU MDR, what would be the impact to the ASEAN regulations which leverage the EU approval? For eg, A registered product is reclassified according to EU MDR.

  6. With harmonization to AMDD, will the individual ASEAN country maintain the country specific regulations?

  7. How does ASEAN plans to recognise safety standards as part of Regulatory/ product compliance? Eg.ISO/IEC

  8. How the list of products for various classes be harmonized across ASEAN countries. For the products which are under household care or cosmetics category in some and in MD category how will that be a

  9. Will ASEAN AMDC guidance documents available for industry /public access?

  10. There is define terminology of Authorized Representative which is clearly different from importer and distributor in Singapore and Malaysia. I would like to know view of other ASEAN countries

  11. How the ASEAN countries to harmonize the own regulation in accordance to AMDD? Eg. Type of medical device required for registration. Does AMDC able to release general the list of medical devices?

  12. What is the current status of GDPMDS, or similar requirement, implementation in ASEAN?

 

Philippines

  1. Does the Philippines FDA plan to recognize product approvals from other jurisdictions (such as the US or the EU) to streamline the pre-market review process?

  2. What is the process and planned timeline for implementing the Administrative Order 2018-2002? Is the order final, or are there opportunities for stakeholder input?

  3. Can  the foreign legal manufacturer be an applicant to submit the registration? Or does the applicant need to have a legal entity in Philippines?

  4. When can we expect an Administrative Order for IVDs?

  5. Proposed implementation timeline of regulation for IVD medical devices

  6. How and when would the existing CPRs transit to the new AMDD regulatory framework? During renewal?

  7. Will implementation of AMDD be Risk based or list based

  8. Do Research Use Only (RUO) products require product registration eg. Are they classified as medical devices/IVDs?

  9. What is the expected date for IVD regulation published?

  10. How to Harmonize to AMDD if the Risk classification is not following CSDT?

  11. With the implementation of new AO, will the existing CPRs that are not expired yet (those expiring in 2020-2022) still be valid?

  12. Is there a distinction between license holders and importers/distributors such that license holders need to authorize them to import and distribute products in the country?

  13. With the new implementation of MD guidelines, what will happen to the existing CPR certificate? Is it still effective?

  14. With the new implementation of PHP guidelines, can we still have multiple distributors for a product?

  15. Do we need to have all labelling to be translated to PhP and /or Eng?

  16. When is the implementation of PHP labelling? Please elaborate on MDAE reporting statement for labelling requirement?

 

Thailand

  1. What is the AMDD IVD implementation in Thailand?

  2. Proposed implementation timeline of regulation for IVD medical devices

  3. Will FDA plan to change requirement for reporting of FER from real time reporting to use once or twice a year?

 

Singapore

  1. What would be the impact to the SG regulation with the upcoming EU MDR implementation. For eg, what does it mean to sg if the registered product is reclassified according to EUMDR?

  2. HSA: what is the Essential Requirement update on the guidance? What is the reason for such update?

  3. Will Class A (non-sterile) Medical Device be included in the Public Online Search System?

  4. When will the draft of Health Products (Medical Devices) Regulation be published for comment?

 

Brunei

  1. What is the plan for AMDD implementation?

  2. The draft order to be discussed in 2018, is it going to incorporate AMDD requirement for premarket requirement? When will be the implementation date of premarket requirement?

 

Indonesia

  1. When and how halal requirements impacting medical devices registration as Halal requirements had been in discussion and to be implemented on drug products, cosmetics and health supplement?

  2. Please advise the exact requirements for products intended for Research Use Only (RUOs) (products which are not categorized as IVDs).

  3. When you say “prioritize local industry” under Pres. Instruction 6, what do you mean b that? Subsidies, government programs, incentives?

  4. Is there a distinction between license holders and importers/distributors such that license holders need to authorize them to import and distribute products in the country?

  5. What is the grouping guideline?

  6. Why will local products receive quicker review than imported ones? This appears discriminatory on surface.

  7. RUO product registration regulations, RUO certificate issued from the country of origin is required? Some countries, the governments do not issue such certificate, any advice on it?

 

Cambodia

  1. New regulations in Cambodia say reagents need to be separated from instruments. Is an English version of these regulations available?

  2. Will the MOH consider exempting Research Use Only (RUO) since it is not classified as medical devices?

  3. This is a general question – will there eventually be an online registration platform for Cambodia/Myanmar? If yes, when will it be implemented?

 

Vietnam

  1. Do Research Use Only (RUO) products require product registration eg. Are they classified as medical devices/IVDs?

  2. May we request MITG get regulatory updates from Myanmar and Vietnam, even though their regulators are not here.

 

Myanmar

  1. This is a general question – will there eventually be an online registration platform for Cambodia/Myanmar? If yes, when will it be implemented?

  2. May we request MITG get regulatory updates from Myanmar and Vietnam, even though their regulators are not here.

 

Malaysia 

  1. How is MDA handling change notification submissions/approvals that it is busy with all the reviews of the existing (on market) products?

  2. What is the status of the halal law standard, and has the scope of the standard narrowed to cover only device made with animal material (such as heart valve)?

  3. Will applications submitted before June 30, 2016 be able to obtain approval before June 30,2018, the date for full enforcement of registration requirements for medical devices?

  4. Will the change notification what is submitted be reflected in the certificate? Will MDA move into the approach of softcopy cert just like what Indonesia is working on?

  5. What is MDA plan in looking into product registration renewal?

  6. For home is device, shall Bahasa Malaysia be reflected in the labelling of the outer carton and the primary packaging of just IFU is sufficient because sometimes carton has no space?

  7. What is he Turn-Around Time for Special Access Application via Email in Dec 2017 and there is no acknowledgement given by MDA till date. Can we implement the changes if there is no response from MDA

  8. Can the IFU be electric?

  9. 1)Can one AR appoint more than 1 distributor for the same product? 2)Does sub-distributor (Doing warehouse, distribution or transportation) need to be GDPMD certified?

  10. Will Malaysia reconsider the need to label medical devices with the registration number? This is a stretch on industry resources. Please consider it is enough to label with AR contact.

  11. When should we submit for Establishment License renewal application? MDR mentioned one year in advance. But we were advised otherwise to submit later

  12. For Change Ownership Application, when shall the Current AR return the product Registration Certificates back to MDA?

  13. When and how halal requirements impacting medical registration as Halal requirements had had been in discussion and to be implemented on drug products, cosmetics and health supplement?

  14. Would MDA consider using the same registration number assigned to approved products on renewals? This will ease industry in continued effort to comply with the labelling requirements.

  15. What is the Turn-Around-Time for the application of Notification Of Exemption From Registration Of Medical Devices For The Purpose Of Clinical Research and Performance Evaluation?

  16. If no reply from MDA for Change Ownership Application, can we import under New AR who made application?

  17. We emailed a Change Ownership Application and enquire on when to purchase and provide the Bank Draft for the application, there is no response from MDA. Is there any misstep?

  18. Could the application continue?

  19. Will there be any plan for MDA to have an outline payment platform instead of bank draft for payment?

  20. Will the listing of Technical Personnel who deals with maintenance testing, installing, commissioning, disposal of medical devices become mandatory? If yes, in which year?

  21. We recently change address and gotten new GDPMD cert. this is during the time when we should go for license renewal. Hence should we go for renewal application or change application?

     

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